Annual Comprehensive List of Guidance Documents at the Food and Drug Administration

---
identifier: "/us/fr/06-2941"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Annual Comprehensive List of Guidance Documents at the Food and Drug Administration"
title_number: 0
title_name: "Federal Register"
section_number: "06-2941"
section_name: "Annual Comprehensive List of Guidance Documents at the Food and Drug Administration"
positive_law: false
currency: "2006-03-28"
last_updated: "2006-03-28"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "06-2941"
document_type: "notice"
publication_date: "2006-03-28"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "71 FR 15422"
fr_volume: 71
docket_ids:
  - "Docket No. 1998N-0046"
fr_action: "Notice."
---


#  Annual Comprehensive List of Guidance Documents at the Food and Drug Administration

**AGENCY:**

Food and Drug Administration, HHS.

**ACTION:**

Notice.

**SUMMARY:**

The Food and Drug Administration (FDA) is publishing its annual comprehensive list of all guidance documents currently in use at the agency. This list is being published under FDA's good guidance practices (GGPs) regulations. It is intended to inform the public of the existence and availability of all of our current guidance documents. It also provides information on guidance documents that have been added or withdrawn in the past year.

**DATES:**

We welcome general comments on this list and on agency guidance documents at any time.

**ADDRESSES:**

Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . For information on a specific guidance or to obtain a hard copy of any of the guidances currently in use, contact the appropriate Center listed in the *SUPPLEMENTARY INFORMATION* section of this document.

**FOR FURTHER INFORMATION CONTACT:**

Regarding GGPs: Lisa Helmanis, Office of Policy (HF-26), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3480.

**SUPPLEMENTARY INFORMATION:**

**I.  Background**

FDA's GGPs were published in the *Federal Register* of September 19, 2000 (65 FR 56468), and became effective October 19, 2000. GGPs (§ 10.115 (21 CFR 10.115)) are intended to ensure involvement of the public in the development of guidance documents, and to enhance understanding of the availability, nature, and legal effect of such guidance. In § 10.115(n)(2), FDA stated that it intended to publish an annual comprehensive list of guidance documents. The list in this document updates a comprehensive list that published January 5, 2005 (70 FR 824).

This year FDA has adopted a new format for its annual comprehensive guidance list. This new format is intended to increase the timeliness of the annual comprehensive list. For information on a specific guidance or to obtain a hard copy, please refer to the heading of each Center's section (sections II through VIII of this document). The list of guidance documents that have been withdrawn is for those guidances that have been withdrawn from January 5, 2005, to January 5, 2006. The list of current guidance documents is a printout of FDA's Web site as of January 31, 2006 or February 1, 2006. You are encouraged to use FDA's Web site as the most up-to-date source for all current guidance documents in use by the agency, as the Web site is updated on a daily basis.

In accordance with the agency's general policy on guidances, you may comment on this list and on any FDA guidance document at any time.

We have organized the documents by the issuing Center or Office within FDA. The dates in the list refer to the date we issued the guidances or, where applicable, the last date we revised a document. Because each issuing Center or Office maintains its own database, there are slight variations in the way in which they provide the information in this document.

**II.  Center for Biologics Evaluation and Research (CBER)**

For information on a specific guidance document or to obtain a hard copy, contact: Office of Communication, Training, and Manufacturers Assistance, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 1-800-835-4709 or 301-827-1800, *http://www.fda.gov/cber/guidelines.htm* .

The following is a list of CBER guidance documents that have been withdrawn from January 5, 2005, to January 5, 2006.

| Title of Document | Date of Issuance | Date of Withdrawal |
| --- | --- | --- |
| Draft Guideline for the Validation of Blood Establishment Computer Systems | 9/28/1993 | 3/9/2005 |
| Draft Guidance for Reviewers:  Premarket Notification Submissions for Automated Testing Instruments Used in Blood Establishments | 8/3/2001 | 6/28/2005 |
| Guidance for Industry:  Discontinuation of Donor Referral Related to Recent Fever with Headache as a Symptom of West Nile Virus Infection | 5/6/2005 | 6/30/2005 |

The following is a copy of the list of current CBER guidance documents obtained from the FDA Web site on March 14, 2006.

|  |
| --- |
| 2006 |
| Draft Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines—3/2/2006 |
| Draft Guidance for Industry: Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines—3/2/2006 |
| FDA Initiative Helps Expedite Development of Seasonal and Pandemic Flu Vaccines—3/2/2006 |
| Guidance for Industry: Reports on the Status of Postmarketing Study Commitments—Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997—2/15/2006 |
| Guidance for Industry: Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications—2/13/2006 |
| Draft Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims—2/2/2006 |
| Guidance for Industry: Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products—Content and Format—1/18/2006 |
| Guidance for Industry: Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products—Content and Format—1/18/2006 |
| Draft Guidance for Industry: Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products—Content and Format—1/18/2006 |
| Draft Guidance for Industry: Labeling for Human Prescription Drug and Biological Products—Implementing the New Content and Format Requirements—1/18/2006 |
| Draft Guidance for Industry: INDs—Approaches to Complying with CGMP During Phase 1—1/12/2006 |
| Guidance for Industry: Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP—1/11/2006 |
| Guidance for Industry: Fast Track Drug Development Programs—Designation, Development, and Application Review—1/11/2006 |
| Appendix 2 |
| Appendix 3—CDER MAPP 6020.3, CBER SOPP 8405 |
| Appendix 4 |
| 2005 |
| Draft Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees—12/30/2005 |
| FEDERAL REGISTER: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees—12/30/3005 |
| Draft Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency—11/30/2005 |
| Guidance for Industry: MedWatch Form FDA 3500A: Mandatory Reporting of Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)—11/30/2005 |
| Draft Guidance for Industry: Recommendations for Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin (IgG) Antibodies—10/19/2005 |
| International Conference on Harmonisation (ICH); Guidance for Industry: E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs—10/19/2005 |
| International Conference on Harmonisation (ICH); Guidance for Industry: S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals—10/19/2005 |
| Guidance for Industry: Providing Regulatory Submissions in Electronic Format—Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications—10/18/2005 |
| International Conference on Harmonisation (ICH); Guidance for Industry: Granularity Document Annex to M4: Organization of the CTD—10/18/2005 |
| Draft Guidance for Industry and FDA Staff: Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended—Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices—10/7/2005 |
| Draft Guidance for Industry and FDA Staff: Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002—Identification of Manufacturer of Medical Devices—6/19/2003 |
| Draft Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods—9/30/2005 |
| International Conference on Harmonisation (ICH); Guidance for Industry: E2B(R) Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports—9/30/2005 |
| Draft Guidance for Industry: Using Electronic Means to Distribute Certain Product Information—9/29/2005 |
| Guidance for Industry: Collection of Race and Ethnicity Data in Clinical Trials—9/19/2005 |
| Guidance for Industry, FDA Staff, and FDA-Accredited Third Parties: Requests for Inspection by an Accredited Person under the Inspection by Accredited Persons Program Authorized by Section 201 of the Medical Device User Fee and Modernization Act of 2002—9/15/2005 |
| Draft Guidance for Industry: How to Comply with the Pediatric Research Equity Act—9/7/2005 |
| International Conference on Harmonisation (ICH); Draft Guideline: M5 Data Elements and Standards for Drug Dictionaries—9/2/2005 |
| Draft Guidance for Industry: Gene Therapy Clinical Trials—Observing Participants for Delayed Adverse Events—8/23/2005 |
| International Conference on Harmonisation (ICH); Draft Consensus Guideline: Q9 Quality Risk Management—8/5/2005 |
| Draft Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry—7/19/2005 |
| Draft Guidance: Emergency Use Authorization of Medical Products—7/5/2005 |
| FEDERAL REGISTER: Guidance for Industry: Discontinuation of Donor Deferral Related to Recent Fever with Headache as a Symptom of West Nile Virus Infection; Withdrawal of Guidance—6/30/2005 |
| International Conference on Harmonisation (ICH); Guidance for Industry: Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process—6/29/2005 |
| FEDERAL REGISTER: Draft Guidance for Food and Drug Administration Reviewers: Premarket Notification Submissions for Automated Testing Instruments Used in Blood Establishments; Withdrawal of Guidance—6/28/2005 |
| Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection—6/23/2005 |
| Draft Guidance for Industry: Bar Code Label Requirements—Questions and Answers—6/7/2005 |
| Guidance for Industry: Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients—5/18/2005 |
| Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices—5/12/2005 |
| Draft Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials—4/29/2005 |
| Reviewer Guidance: Evaluating the Risks of Drug Exposure in Human Pregnancies—4/27/2005 |
| Guidance for Industry and FDA Staff: Application User Fees for Combination Products—4/20/2005 |
| Guidance for Industry: Providing Regulatory Submissions in Electronic Format—Content of Labeling—4/20/2005 |
| Guidance for Industry and FDA Staff: Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product—4/11/2005 |
| Draft Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics—4/1/2005 |
| International Conference on Harmonisation (ICH); Guidance for Industry: E2E Pharmacovigilance Planning—3/31/2005 |
| Guidance for Review Staff and Industry: Good Review Management Principles for PDUFA Products—3/30/2005 |
| Guidance for Industry: Premarketing Risk Assessment—3/25/2005 |
| Guidance for Industry: Development and Use of Risk Minimization Action Plans—3/25/2005 |
| Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment—3/25/2005 |
| Draft Guidance for Industry: Using a Centralized IRB Review Process in Multicenter Clinical Trials—3/25/2005 |
| Guidance for Industry: Pharmacogenomic Data Submissions—3/22/2005 |
| Attachment to Guidance on Pharmacogenomic Data Submissions—3/22/2005 |
| International Conference on Harmonisation (ICH) Guidance for Industry: M2: eCTD Specification; Questions & Answers and Change Requests—3/11/2005 |
| Companion Document: Current Q&As and Change Requests—3/11/2005—Updated—7/18/2005—Updated—1/6/2006 |
| International Conference on Harmonisation (ICH) Guidance for Industry: M2 eCTD: Electronic Common Technical Document Specification—4/1/2003 |
| International Conference on Harmonisation (ICH) Guidance for Industry: E2B(M): Data Elements for Transmission of Individual Case Safety Reports: Questions and Answers (Revision 2)—3/9/2005 |
| FEDERAL REGISTER: Draft Guideline for the Validation of Blood Establishment Computer Systems; Withdrawal of Guidance—3/9/2005 |
| Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle—3/9/2005 |
| Draft Guidance for Industry: Manufacturing Biological Drug Substances, Intermediates, or Products Using Spore-Forming Microorganisms—2/23/2005 |
| Draft Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications—2/17/2005 |
| Points to Consider on Plasmid DNA Vaccines for Preventive Infectious Disease Indications—12/27/1996 |
| FEDERAL REGISTER: Annual Comprehensive List of Guidance Documents at the Food and Drug Administration; Correction—2/11/2005 |
| FEDERAL REGISTER: Annual Comprehensive List of Guidance Documents at the Food and Drug Administration—1/5/2005 |
| International Conference on Harmonisation (ICH); Draft Guidance on Q8 Pharmaceutical Development—2/8/2005 |
| Draft Guidance for Industry: Clinical Lactation Studies—Study Design, Data Analysis, and Recommendations for Labeling—2/7/2005 |
| International Conference on Harmonisation (ICH); Draft Guidance on S8 Immunotoxicity Studies for Human Pharmaceuticals—2/7/2005 |
| Guidance for Industry: Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees—1/3/2005 |
| 2004 |
| International Conference on Harmonisation (ICH); Guidance for Industry: M-4: CTD—Efficacy: Questions and Answers (Revision 3)—12/22/2004 |
| International Conference on Harmonisation (ICH); Guidance for Industry: M4: The CTD—General: Questions and Answers (Revision 3)—12/22/2004 |
| Guidance for Industry and FDA Staff: Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use—11/30/2004 |
| Guidance for Industry: Continuous Marketing Applications: Pilot 2—Scientific Feedback and Interactions During Development of Fast Track Products Under the Prescription Drug User Fee Act of 1992; Notice of extension of application deadline—11/19/2004 |
| Guidance for Industry: Continuous Marketing Applications: Pilot 2—Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA—10/6/2003 |
| Guidance for Industry and FDA Staff: Resolution of Disputes Concerning Payment or Refund of Medical Device User Fees Under MDUFMA—11/17/2004 |
| Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)—11/12/2004 |
| Draft Guidance for FDA Review Staff and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)—11/8/2004 |
| Draft Guidance for Industry: Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as Red Blood Cell Substitutes—10/28/2004 |
| Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components (including Source Plasma and Source Leukocytes) to Adequately and Appropriately Reduce the Risk of Transmission of HIV-1 and HCV—10/21/2004 |
| Guidance for Industry, FDA Staff, and Third Parties: Implementation of the Inspection by Accredited Persons Program Under The Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria—10/1/2004 |
| Guidance for Industry: FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information—10/1/2004 |
| Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice—9/29/2004 |
| Draft Guidance for Industry: Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations—9/29/2004 |
| Draft Guidance for Industry and FDA: Current Good Manufacturing Practice for Combination Products—9/29/2004 |
| Draft Guidance for Industry: Computerized Systems Used in Clinical Trials 9/29/2004 |
| Guidance for Industry: Computerized Systems Used in Clinical Trials—5/10/1999 |
| FEDERAL REGISTER—Annual Guidance Agenda—9/23/2004 |
| Guidance for Industry and Clinical Investigators: The Use of Clinical Holds Following Clinical Investigator Misconduct—9/2/2004 |
| Guidance on Research Involving Coded Private Information or Biological Specimens—8/30/2004 |
| Guidance for Industry and FDA: FY 2005 MDUFMA Small Business Qualification Worksheet and Certification—8/20/2004 |
| Guidance for Industry: Independent Consultants for Biotechnology Clinical Trial Protocols—8/18/2004 |
| Guidance for Industry: Available Therapy—7/21/2004 |
| Guidance for Industry: FDA Export Certificates (Corrected to update the Medical Devices contact phone number 4/27/2005)—7/12/2004 |
| International Conference on Harmonisation (ICH); Guidance for Industry: Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV—7/2/2004 |
| Guidance for Industry: Developing Medical Imaging Drug and Biological Products—6/17/2004 |
| Part 1: Conducting Safety Assessments |
| Part 2: Clinical Indications |
| Part 3: Design, Analysis, and Interpretation of Clinical Studies |
| International Conference on Harmonisation (ICH); Guidance for Industry: M4: The CTD—Quality: Questions and Answers/Location Issues—6/8/2004 |
| International Conference on Harmonisation (ICH); Guidance for Industry: Q1E Evaluation of Stability Data—6/7/2004 |
| International Conference on Harmonisation (ICH); Guidance for Industry: E5—Ethnic Factors in the Acceptability of Foreign Clinical Data—Questions and Answers—6/3/2004 |
| Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Notification Submissions (510(k)s)—5/28/2004 |
| Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment—5/20/2004 |
| Draft Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)—5/20/2004 |
| Questions and Answers for Roll-Out of Donor Eligibility Final Rule and Draft Guidance |
| Draft Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components—4/23/2004 |
| Draft Guidance for Industry: Vaccinia Virus—Developing Drugs to Mitigate Complications from Smallpox Vaccination—3/8/2004 |
| International Conference on Harmonisation (ICH); Guidance for Industry: Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs—2/4/2004 |
| International Conference on Harmonisation (ICH); Guidance for Industry: E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs—11/1996 |
| Draft Guidance for Industry and FDA: Consumer-Directed Broadcast Advertising of Restricted Devices—2/4/2004 |
| Draft Guidance for Industry: Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements—2/4/2004 |
| Example of Fictional Highlights of Prescribing Information (Based on Proposed Physician Labeling Rule)—2/4/2004 |
| Example of Fictional Highlights of Prescribing Information (Based on Proposed Physician Labeling Rule) Translated in Consumer-Friendly Language and Formatted for Use in Consumer-Directed Advertisement—2/4/2004 |
| Draft Guidance for Industry: “Help-Seeking” and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms—2/4/2004 |
| Draft Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (Revision 1)—1/26/2004 |
| Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions—3/18/2002 |
| Guidance for Industry: IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer (Revision 1)—1/16/2004 |
| Draft Guidance for Industry: Drug Substance—Chemistry, Manufacturing, and Controls Information—1/6/2004 |
| 2003 |
| Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Human Dura Mater—12/17/2003 |
| Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components—12/09/2003 |
| Guidance for Industry and FDA Staff: Expedited Review of Premarket Submissions for Devices—11/21/2003 |
| Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Approval Applications—11/21/2003 |
| Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single Submission—11/21/2003 |
| Guidance for Industry and FDA: Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products—3/12/2003 |
| International Conference on Harmonisation (ICH); Guidance for Industry: Q1A(R2) Stability Testing of New Drug Substances and Products—11/20/2003 |
| International Conference on Harmonisation (ICH); Guidance for Industry: Q3B(R) Impurities in New Drug Products—11/13/2003 |
| International Conference on Harmonisation (ICH); Guidance for Industry: Q3C—Tables and List—11/12/2003 |
| Guidance for Industry: Q3C Impurities: Residual Solvents—12/24/1997 |
| Guidance for Industry: Product Recalls, Including Removals and Corrections—10/31/2003 |
| Guidance for Industry and FDA Staff: Premarket Approval Application Modular Review—10/31/2003 |
| Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Serological Reagents for the Laboratory Diagnosis of West Nile Virus—10/30/2003 |
| Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format—General Considerations—10/22/2003 |
| Guidance for Industry: Providing Regulatory Submissions in Electronic Format—General Considerations—1/28/1999 |
| Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Performance Assessment—10/8/2003 |
| Guidance for Industry: Continuous Marketing Applications: Pilot 1—Reviewable Units for Fast Track Products Under PDUFA—10/6/2003 |
| Guidance for Industry: Notifying FDA of Fatalities Related to Blood Collection or Transfusion—9/22/2003 |
| Guidance for Industry: Revised Recommendations for the Assessment of Donor Suitability and Blood Product Safety in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS—9/16/2003 |
| Guidance for Industry: Recommendations for the Assessment of Donor Suitability and Blood Product Safety in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS—4/17/2003 |
| Question and Answer on FDA Guidance Entitled “Recommendations for the Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Suspected and Probable Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS”—Since Publication of this guidance, CDC issued a health alert for travelers arriving from Toronto Canada, and updated their case definition. As discussed in the guidance under section II.B.3., Updated Information on Case Definitions in Areas Affected by SARS, the FDA indicated that you should consult with the CDC website and phone number for updates. Phone (888) 246-2675. |
| Updated Interim U.S. Case Definition of Severe Acute Respiratory Syndrome (SARS). http://www.cdc.gov/ncidod/sars/casedefinition.htm. |
| ICH Draft Guidance: E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting—9/12/2003 |
| Draft Guidance for Industry: Comparability Protocols—Protein Drug Products and Biological Products—Chemistry, Manufacturing, and Controls Information—9/3/2003 |
| Guidance for Industry: Part 11, Electronic Records; Electronic Signatures—Scope and Application—9/3/2003 |
| Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format—Annual Reports for New Drug Applications and Abbreviated New Drug Applications—8/27/2003 |
| Draft Guidance for Reviewers: Instructions and Template for Chemistry, Manufacturing, and Control (CMC) Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications (INDs)—8/15/2003 |
| Guidance for Industry and FDA: FY 2004 MDUFMA Small Business Qualification Worksheet and Certification—8/1/2003 |
| Draft Guidance for Industry and FDA Staff: Premarket Assessment of Pediatric Medical Devices—7/24/2003 |
| Guidance for Industry: Streamlining the Donor Interview Process: Recommendations for Self-Administered Questionnaires—7/3/2003 |
| Guidance for Industry and FDA Staff: Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices—7/3/2003 |
| Draft Guidance for Industry: Revised Recommendations for Donor and Product Management Based on Screening Tests for Syphilis—6/25/2003 |
| Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format—Postmarketing Periodic Adverse Drug Experience Reports—6/23/2003 |
| Guidance for FDA Staff: The Leveraging Handbook, An Agency Resource for Effective Collaborations—6/19/2003 |
| Guidance for Industry: Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling—5/30/2003 |
| Guidance for Industry: Exposure-Response Relationships—Study Design, Data Analysis, and Regulatory Applications—5/5/2003 |
| Guidance for Industry and FDA Staff: Premarket Approval Application Filing Review—5/1/2003 |
| FEDERAL REGISTER—Annual Guidance Agenda—4/4/2003 |
| Guidance for Industry: Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans—4/3/2003 |
| International Conference on Harmonisation (ICH) Guidance for Industry: M2 eCTD: Electronic Common Technical Document Specification—4/1/2003 |
| International Conference on Harmonisation (ICH) Guidance for Industry: M2: eCTD Specification; Questions & Answers and Change Requests—3/11/2005 |
| Companion Document: Current Q&As and Change Requests—3/11/2005—Updated—7/18/2005—Updated—1/6/2006 |
| Guidance for Industry and FDA: FY 2003 MDUFMA Small Business Qualification Worksheet and Certification—3/12/2003 |
| Draft Guidance for Industry; Comparability Protocols—Chemistry, Manufacturing, and Controls Information—2/20/2003 |
| International Conference on Harmonisation (ICH); Guidance for Industry: Q3A Impurities in New Drug Substances—2/11/2003 |
| Guidance for Industry and FDA Staff: Quality System Information for Certain Premarket Application Reviews—2/3/2003 |
| International Conference on Harmonisation (ICH); Guidance for Industry: M4: The CTD—Safety: Questions and Answers—2/3/2003 |
| Draft Guidance for Industry: Drug Product: Chemistry, Manufacturing, and Controls Information—1/28/2003 |
| International Conference on Harmonisation (ICH); Guidance for Industry; Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products—1/15/2003 |
| Draft Guidance for Industry and Reviewers on Estimating the Safe Starting Dose in Clinical Trials for Therapeutics in Adult Healthy Volunteers—1/15/2003 |
| Guidance for Industry: Recommendations for Deferral of Donors and Quarantine and Retrieval of Blood and Blood Products in Recent Recipients of Smallpox Vaccine (Vaccinia Virus) and Certain Contacts of Smallpox VaccineRecipients—12/30/2002—(Corrected 2/4/2003) |
| Questions and Answers on FDA Guidance Entitled “Recommendations for Deferral of Donors and Quarantine and Retrieval of Blood and Blood Products in Recent Recipients of Smallpox Vaccine (Vaccinia Virus) and Certain Contacts of Smallpox Vaccine Recipients” |
| 2002 |
| The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles; Final Guidance for FDA and Industry—10/3/2002 |
| Guidance for Industry: Establishing Pregnancy Exposure Registries—9/20/2002— |
| Draft Guidance for Industry: Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals—9/6/2002 |
| Draft Guidance for Industry: Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)—6/14/2002 |
| Guidance for Industry: Special Protocol Assessment—5/16/2002 |
| Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics; Questions and Answers—5/13/2002 |
| Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics; Chemistry, Manufacturing, and Controls Documentation—7/7/1999 |
| Draft Guidelines for Ensuring the Quality of Information Disseminated to the Public—5/2/2002—HHS Guideline |
| Draft Guidance for Industry: A Modified Lot-Release Specification for Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Blood, Blood Components and Source Plasma Donations—4/10/2002 |
| Guidance for Industry: Providing Regulatory Submissions to CBER in Electronic Format—Investigational New Drug Applications (INDs)—3/26/2002 |
| Electronic IND Demo |
| Guidance for Industry: Validation of Procedures for Processing of Human Tissues Intended for Transplantation—3/8/2002 |
| Draft Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and Their Intimate Contacts—2/1/2002 |
| Draft Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and Their Contacts—12/23/1999 |
| Guidance for Industry: General Principles of Software Validation; Final Guidance for Industry and FDA Staff—1/11/2002 |
| Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products—1/9/2002 |
| Questions and Answers on ”Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products” |
| 2001 |
| Guidance for Industry Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act—11/21/2001 |
| Draft Guidance for Clinical Trial Sponsors On the Establishment and Operation of Clinical Trial Data Monitoring Committees—11/15/2001 |
| Guidance for Industry—Recommendations for Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Possible Exposure to Anthrax—10/17/2001 |
| International Conference on Harmonisation (ICH); Guidance on M4 Common Technical Document—10/16/2001— |
| M4: Organization of the CTD |
| M4E: The CTD—Efficacy |
| M4Q: The CTD—Quality |
| M4S: The CTD—Safety |
| M4S: The CTD—Safety Appendices |
| Guidance for Industry: Content and Format of Geriatric Labeling—10/5/2001 |
| Guidance for Industry: Cancer Drug and Biological Products—Clinical Data in Marketing Applications—10/5/2001 |
| International Conference on Harmonisation (ICH) Guidance; Q7A Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients—9/25/2001 |
| Draft Guidance for Industry: Submitting Marketing Applications According to the ICH-CTD Format—General Considerations—9/5/2001 |
| Draft Guidance for Industry: Premarket Notifications [510(k)s] for In Vitro HIV Drug Resistance Genotype Assays: Special Controls—8/28/2001 |
| Draft Guidance for Industry: Submitting Type V Drug Master Files to the Center for Biologics Evaluation and Research—8/22/2001 |
| Guidance for Industry: Variances for Blood Collection from Individuals with Hereditary Hemochromatosis—8/22/2001 |
| Draft Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments—8/10/2001 |
| Draft Guidance for Industry: Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components—8/10/2001 |
| Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture—8/7/2001 |
| Guidance for FDA Reviewers: Premarket Notification Submissions for Blood and Plasma Warmers—7/19/2001 |
| Guidance for FDA Reviewers: Premarket Notification Submissions for Transfer Sets (Excluding Sterile Connecting Devices)—7/19/2001 |
| Guidance for FDA Reviewers: Premarket Notification Submissions for Empty Containers for the Collection and Processing of Blood and Blood Components—7/19/2001 |
| ICH Guidance for Industry: S7A Safety Pharmacology Studies for Human Pharmaceuticals—7/12/2001 |
| Guidance for Industry: Revised Recommendations Regarding Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors—7/11/2001 |
| Guidance for Industry: CBER Pilot Licensing Program for Immunization of Source Plasma Donors Using Immunogen Red Blood Cells Obtained From An Outside Supplier—7/11/2001 |
| Guidance for Industry: IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing and Controls Information—5/25/2001 |
| Draft Guidance for Industry: Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution—5/14/2001 |
| ICH Guidance for Industry: E 10 Choice of Control Group and Related Issues in Clinical Trials—5/11/2001 |
| Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format—Postmarketing Expedited Safety Reports—5/3/2001 |
| Guidance for Industry: Monoclonal Antibodies Used as Reagents in Drug Manufacturing—3/29/2001 |
| Guidance for Industry: Financial Disclosure by Clinical Investigators—3/28/2001 |
| Guidance for Industry: Acceptance of Foreign Clinical Studies—3/13/2001 |
| Draft Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines—3/12/2001 |
| Draft Guidance for Industry: Disclosing Information Provided to Advisory Committees in Connection with Open Advisory Committee Meetings Related to the Testing or Approval of Biologic Products and Convened by the Center for Biologics Evaluation and Research—2/15/2001 |
| Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods—Technical Correction February 2001—2/13/2001 |
| Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format—Prescription Drug Advertising and Promotional Labeling—1/31/2001 |
| Draft Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion—1/23/2001 |
| PHS Guideline on Infectious Disease Issues in Xenotransplantation—1/19/2001 |
| 2000 |
| International Conference on Harmonisation; Guidance on Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances—12/29/2000 |
| International Conference on Harmonisation (ICH) Guidance for Industry: E11 Clinical Investigation of Medicinal Products in the Pediatric Population—12/15/2000 |
| Draft Guidance for Industry: Recommendations for Complying With the Pediatric Rule (21 CFR 314.55(a) and 601.27(a))—12/4/2000 |
| Guidance for Industry: Use of Sterile Connecting Devices in Blood Bank Practices—11/22/2000 |
| Guidance for Reviewers: Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A Revised Protocol—11/20/2000 |
| Guidance for Industry: Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts—11/20/2000 |
| Guidance for Industry: Submitting and Reviewing Complete Responses to Clinical Holds—10/26/2000 |
| Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors—10/18/2000 |
| Guidance for Industry: Q & A Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products—10/3/2000 |
| Guidance for Industry: Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products—11/1995 |
| Draft Guidance for Industry: Analytical Procedures and Methods Validation—Chemistry, Manufacturing, and Controls Documentation—8/30/2000 |
| Guidance for Industry and FDA Staff: Guidance on Amended Procedures for Advisory Panel Meetings—7/22/2000 |
| Draft Guidance for Industry: Chronic Cutaneous Ulcer and Burn Wounds—Developing Products for Treatment—6/28/2000 |
| Guidance for Industry: Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric Blood Specimens—6/23/2000 |
| Draft Guidance for Industry: Pediatric Oncology Studies In Response to a Written Request—6/21/2000 |
| Draft Guidance for Industry: Recommendations for Donor Questioning Regarding Possible Exposure to Malaria—6/8/2000 |
| Guidance for Industry: Recognition and Use of a Standard for the Uniform Labeling of Blood and Blood Components—6/6/2000 |
| Guidance for Industry: United States Industry Consensus Standard for the Uniform labeling of Blood and Blood Components Using ISBT 128—11/1999 |
| Guidance for Industry: Gamma Irradiation of Blood and Blood Components: A Pilot Program for Licensing—3/15/2000 |
| Guidance for Industry: Formal Meetings With Sponsors and Applicants for PDUFA Products—3/7/2000 |
| Guidance for Industry: Formal Dispute Resolution: Appeals Above the Division Level—3/7/2000 |
| International Conference on Harmonsation of Technical Requirements for Registration of Pharmaceuticals for Human Use—2/10/2000 |
| 1999 |
| Guidance for Industry: In the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency Viruses Types 1 and 2—12/14/1999 |
| Guidance for Industry: In Vivo Drug Metabolism / Drug Interaction Studies—Study Design, Data Analysis and Recommendations for Dosing and Labeling—11/24/1999 |
| REVISED Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format—Biologics Marketing Applications [Biologics License Application (BLA), Product License Application (PLA) / Establishment License Application (ELA) and New Drug Application (NDA)]—11/12/1999, REVISED 11/22/1999 |
| CBER Computer Assisted License Application (CALA) Questionnaire |
| Guidance for Industry: Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug and Cosmetic Act—10/8/1999 |
| Guidance for Industry: Submission of Abbreviated Reports and Synopses in Support of Marketing Applications—9/13/1999 |
| Guidance for Industry: Possible Dioxin/PCB Contamination of Drug and Biological Products—8/27/1999 |
| ICH Guidance on Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products—8/18/1999 |
| Guidance for Industry: Consumer-Directed Broadcast Advertisements—8/6/1999 |
| Draft Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics—8/3/1999 |
| Draft Guidance for Industry: Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations—7/24/1999 |
| Draft Guidance for Industry: Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (OA)—7/15/1999 |
| ICH Guidance on the Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing); Availability—6/25/1999 |
| Draft Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis C Virus (HCV); (2) Supplemental Testing, and the Notification of Consignees and Transfusion Recipients of Donor Test Results for Antibody to HCV (Anti-HCV)—6/17/1999 |
| FEDERAL REGISTER Notice of Availability—6/22/1999 |
| Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Antidoby to Hepatitis C Virus (Anti-HCV); (2) Supplemental Testing, and the Notification of Consignees and Blood Recipients of Donor Test Results for Anti-HCV—9/23/1998 |
| Guidance for Industry: Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use—5/20/1999 |
| Draft Guidance for Industry For Platelet Testing and Evaluation of Platelet Substitute Products—5/20/1999 |
| Guidance for Industry For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and For the Completion of the Form FDA 356h “Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use”—5/10/1999 |
| Guidance for Industry On the Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for an Allergenic Extract or Allergen Patch Test—4/23/1999 |
| Guidance for Industry: Public Health Issues Posed by the Use of Nonhuman Primate Xenografts in Humans—4/6/1999 |
| Draft Guidance for Industry: Accelerated Approval Products—Submission of Promotional Materials—3/26/1999 |
| Draft Guidance for Industry: Product Name Placement, Size and Prominence in Advertising and Promotional Labeling—3/12/1999 |
| Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Biological In Vitro Diagnostic Product—3/8/1999 |
| Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Plasma-Derived Biological Products, Animal Plasma or Serum-Derived Products—2/17/1999 |
| Guidance for Industry: Clinical Development Programs for Drugs, Devices and Biological Products for the Treatment of Rheumatoid Arthritis (RA)—2/17/1999 |
| Guidance for Industry: Population Pharmacokinetics—2/10/1999 |
| Guidance for Industry: FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products—2/3/1999 |
| Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product—1/5/1999 |
| 1998 |
| Draft Guidance for Industry: General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products—11/30/1998 |
| Guidance for Industry; Advisory Committees: Implementing Section 120 of the Food and Drug Administration Modernization Act of 1997—10/30/1998 |
| Draft Guidance for Industry: Submitting Debarment Certification Statements—10/2/1998 |
| ICH Guidance on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin—9/24/1998 |
| Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Antidoby to Hepatitis C Virus (Anti-HCV); (2) Supplemental Testing, and the Notification of Consignees and Blood Recipients of Donor Test Results for Anti-HCV—9/23/1998 |
| ICH Guidance on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products—9/21/1998 |
| ICH Guidance on Statistical Principles for Clinical Trials—9/16/1998 |
| Withdrawal of “Guidance for Industry: Supplemental Testing and the Notification of Consignees of Donor Test Results for Antibody to Hepatitis C Virus (Anti-HCV)”—Information Sheet—9/8/1998 |
| Guidance for Industry: Supplemental Testing and the Notification of Consignees of Donor Test Results for Antibody to Hepatitis C Virus (Anti-HCV)—3/20/1998 |
| Guidance for Industry: How to Complete the Vaccine Adverse Reporting System Form (VAERS-1)—9/8/1998 |
| Guidance for Industry: Environmental Assessment of Human Drug and Biologics Applications—7/27/1998 |
| Guidance for Industry: Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997—Elimination of Certain Labeling Requirements—7/21/1998 |
| Draft Guidance for Industry: Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996—6/12/1998 |
| Guidance for Industry: Errors and Accidents Regarding Saline Dilution of Samples Used for Viral Marker Testing—6/11/1998 |
| ICH Guidance on Ethnic Factors in the Acceptability of Foreign Clinical Data—6/10/1998 |
| Draft Guidance for Industry: Stability Testing of Drug Substances and Drug Products—6/8/1998 |
| Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drugs and Biological Products—5/15/1998 |
| Guidance for Industry: Standards for the Prompt Review of Efficacy Supplements, Including Priority Efficacy Supplements—5/15/1998 |
| Guidance for Industry: Pharmacokinetics in Patients with Impaired Renal Function—Study Design, Data Analysis and Impact on Dosing and Labeling—5/15/1998 |
| Guidance for Industry: Classifying Resubmissions in Response to Action Letters—5/14/1998 |
| Draft Guidance for Industry: Instructions for Submitting Electronic Lot Release Protocols to the Center for Biologics Evaluation and Research—5/13/1998 |
| Draft Guidance for Industry: Manufacturing, Processing or Holding Active Pharmaceutical Ingredients—4/17/1998 |
| Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy—3/30/1998 |
| Draft Guidance for Industry: Container and Closure Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products—1/28/1998 |
| Guidance for Industry: Year 2000 Date Change for Computer Systems and Software Applications Used in the Manufacture of Blood Products—1/8/1998 |
| 1997 |
| Draft Guidance for Industry: Promoting Medical Products in a Changing Healthcare Environment; I. Medical Product Promotion by Healthcare Organizations or Pharmacy Benefits Management Companies (PBMS)—12/1997 |
| Final Guidance on Industry-Supported Scientific and Educational Activities; Notice—12/3/1997 |
| Guidance for FDA and Industry: Direct Final Rule Procedures—11/21/1997 |
| Guidance for Industry: Industry-Supported Scientific and Educational Activities—11/1997 |
| Guidance for Industry—The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in FDA-Regulated Products for Human Use—10/07/1997 |
| Guidance for Industry—Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report—8/27/1997 |
| Guidance for Industry—Donor Screening for Antibodies to HTLV-II—8/15/1997 |
| Guidance for Industry—Screening and Testing of Donors of Human Tissue Intended for Transplantation—7/29/1997 |
| Guidance for Industry—Changes to an Approved Application: Biological Products—7/24/1997 |
| Guidance for Industry—Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products—7/24/1997 |
| International Conference on Harmonisation (ICH) Guidance for Industry: Q2B Validation of Analytical Procedures: Methodology—5/19/1997 |
| International Conference on Harmonisation (ICH) Guidelines for the Photostability Testing of New Drug Substances and Products—5/16/1997 |
| Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies—4/10/1997 |
| Proposed Approach to Regulation of Cellular and Tissue-Based Products—2/28/1997 |
| Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use—2/28/1997 |
| Guidance For the Submission of Chemistry, Manufacturing and Controls Information and Establishment Description for Autologous Somatic Cell Therapy Products—1/10/1997 |
| 1996 |
| Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use—8/1996 |
| International Conference on Harmonisation: Final Guidance on Stability Testing of Biotechnological / Biological Products—7/10/1996 |
| Guidance for Industry—The Content and Format for Pediatric Use Supplements—5/1996 |
| Guidance on Applications for Products Comprised of Living Autologous Cells Manipulated ex vivo and Intended for Structural Repair or Reconstruction—5/1996 |
| FDA Guidance Concerning Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-Derived Products—4/1996 |
| International Conference on Harmonisation: Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals—3/1996 |
| International Conference on Harmonisation: Final Guideline on Quality of Biotechnical Products: Analysis of the Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products—2/1996 |
| 1995 and earlier |
| Draft Reviewers' Guide: Disease Associated Antibody Collection Program—10/1/1995 |
| Draft Reviewers' Guide: Informed Consent for Plasmapheresis / Immunization—10/1/1995 |
| Guideline for Quality Assurance in Blood Establishments—7/11/1995 (NOTE: The text version does not contain Tables 1-8) |
| FDA Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and Manufacturing of Biological Products—7/11/1995 |
| Points to Consider in the Manufacture and Testing of Therapeutic Products for Human Use Derived from Transgenic Animals—1995 |
| Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for Synthetic Peptide Substance—11/1/1994 |
| Guidance for Industry for the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products—11/1994 |
| Guidance on Alternatives to Lot Release for Licensed Biological Products—7/14/1993 |
| Draft Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals (1993)—7/12/1993 |
| FDA's Policy Statement Concerning Cooperative Manufacturing Arrangements for Licensed Biologics—11/25/1992 |
| Supplement to the Points to Consider in the Production and Testing of New Drugs and Biologics Produced by Recombinant DNA Technology: Nucleic Acid Characterization and Genetic Stability—4/6/1992 |
| Guideline for the Determination of Residual Moisture in Dried Biological Products—1/1/1990 |
| Guideline for Collection of Blood or Blood Products from Donors with Positive Tests for Infectious Disease Markers (“High Risk” Donors)—10/26/1989 |
| Points to Consider in the Collection, Processing, and Testing of Ex-Vivo Activated Mononeuclear Leukocytes for Administering to Humans—8/22/1989 |
| Draft Points to Consider in the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Antibodies to the Human Immunodeficiency Virus Type 1—8/8/1989 |
| Revised Guideline for the Collection of Platelets, Pheresis—10/7/1988 |
| Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test For Human and Animal Parenteral Drugs, Biological Products and Medical Devices—12/1987 |
| Guideline on General Principles of Process Validation—5/1987 |
| Guideline for the Uniform Labeling of Blood and Blood Components—8/1985 |
| Points to Consider in the Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology—4/10/1985 |
| Interferon Test Procedures: Points to Consider in the Production and Testing of Interferon Intended for Investigational Use in Humans—7/28/1983 |
| Guidelines for Immunization of Source Plasma (Human) Donors with Blood Substances—6/1980 |

**III.  Center for Drug Evaluation and Research (CDER)**

For information on a specific guidance document or to obtain a hard copy, contact: Division of Drug Information, Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573, *http://www.fda.gov/cder/guidance/index.htm* .

The following is a list of CDER guidance documents that have been withdrawn from January 5, 2005, to January 5, 2006.

| Title of Document | Date of Issuance | Date of Withdrawal |
| --- | --- | --- |
| Preclinical Development of Antiviral Drugs | 11/1/1990 | 7/6/2005 |
| Conjugated Estrogens, USP:  LC-MS Method for Both Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical Equivalence | 3/9/2000 | 8/12/2005 |
| Phenytoin/Phenytoin Sodium Capsules, Tablets and Suspension In Vivo Bioequivalence and In Vitro Dissolution Testing | 3/4/1994 | 9/6/2005 |
| Organization of an Abbreviated New Drug Application | 3/2/1999 | 11/18/2005 |
| Preclinical Development of Immunomodulatory Drugs for Treatment of HIV Infection and Associated Disorders | 9/4/1992 | 12/29/2005 |

The following is a copy of a list of current CDER guidance documents obtained from the FDA Web site as of March 14, 2006.

|  |
| --- |
| FDA's Good Guidance Practices regulation of September 19, 2000. |
| Comprehensive List of Guidance Documents  (updated 2/28/2006) |
| Guidance Agenda: Guidances CDER is Planning to Develop During Calendar Year 2006  (03/01/2006) |
| New/Revised/Withdrawn List for 2006 (updated 2/28/2006) |
| New/Revised/Withdrawn List for 2005  (updated 1/4/2006) |
| Advertising |
| Aerosol Steroid Product Safety Information in Prescription Drug Advertising and Promotional Labeling  (Issued 12/1997, Posted 1/12/1998) |
| Consumer-Directed Broadcast Advertisements (Issued 8/1999, Posted 8/6/1999) |
| Questions and Answers (Posted 8/6/1999) |
| Industry-Supported Scientific and Educational Activities (Issued 12/3/1997, Posted 12/4/1997) |
| Advertising Draft |
| Accelerated Approval Products: Submission of Promotional Materials  (Posted 3/26/1999) |
| Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements (Posted 2/4/2004) |
| Labeling Example |
| Labeling Example; Consumer-Friendly Version |
| Consumer-Directed Broadcast Advertising of Restricted Devices (Issued 1/26/2004, Posted 2/4/2004) |
| “Help-Seeking” and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms (Issued 1/26/2004, Posted 2/4/2004) |
| Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling  (Issued 1/1999, Posted 3/12/1999) |
| Promoting Medical Products in a Changing Healthcare Environment; I. Medical Product Promotion by Healthcare Organizations or Pharmacy Management Companies (PBMs)  (Issued 12/1997. Posted 1/5/1998) |
| Biopharmaceutics |
| Bioanalytical Method Validation (Issued 5/2001, Posted 5/22/2001) |
| Bioavailability and Bioequivalence Studies for Orally Administered Drug Products—General Considerations (Issued 3/2003, Posted 3/19/2003) |
| Cholestyramine Powder in Vitro Bioequivalence (Intermin Guidance) |
| Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing (Issued 6/17/2005, Posted 6/17/2005) |
| Corticosteroids, Dermatologic (topical) In Vivo  (Issued 6/2/1995, Posted 3/6/1998) |
| Dissolution Testing of Immediate Release Solid Oral Dosage Forms (Issued 8/1997, Posted 8/25/1997) |
| Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations  (Issued 9/1997, Posted 9/26/1997) |
| Food-Effect Bioavailability and Fed Bioequivalence Studies (Issued 12/2002, Posted 1/30/2003) |
| Metaproterenol Sulfate and Albuterol Metered Dose Inhalers In Vitro   (Issued 6/27/1989, Posted 3/2/1998) |
| Potassium Chloride (slow-release tablets and capsules) In Vivo Bioequivalence and In Vitro Dissolution Testing   (Revised 6/6/1994, Posted 6/22/1998) |
| Statistical Approaches to Establishing Bioequivalence (Issued 2/2001, Posted 2/1/2001) |
| Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. (Issued 8/2000, Posted 8/31/2000) |
| Biopharmaceutics (Draft) |
| Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action (Posted 4/2/2003) |
| Statistical Information from the June 1999 Draft Guidance and Statistical Information for In Vitro Bioequivalence Data   (Posted 4/11/2003) |
| Conjugated Estrogens, USP-LC-MS Method for Both Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical Equivalence. Withdrawn per August 12, 2005, Federal Register notice. |
| CGMPs (Pharmaceutical CGMPs for the 21st Century) |
| Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP (Issued 1/11/2006; Posted 1/11/2006) |
| Questions and Answers on Current Good Manufacturing Practices (cGMP) for Drugs (Posted 8/4/2004) |
| Part 11, Electronic Records; Electronic Signatures—Scope and Application (Posted 9/3/2003) |
| PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (posted 9/29/2004) |
| Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice Posted 9/29/2004 |
| CGMPs (Pharmaceutical CGMPs for the 21st Century)—Draft |
| Comparability Protocols—Protein Drug Products and Biological Products—Chemistry, Manufacturing, and Controls Information (Posted 9/3/2003) |
| Current Good Manufacturing Practice for Combination Products (Posted 9/29/2004) |
| INDs—Approaches to Complying with CGMP's for Phase 1 Drugs (Issued 1/12/2006; Posted 1/12/2006) |
| Powder Blends and Finished Dosage Units—Stratified In-Process Dosage Unit Sampling and Assessment (Issued 11/2003, Posted 11/6/2003) |
| Revised Attachments (Issued 11/2003, Posted 11/21/2003) |
| Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (Posted 9/29/2004) |
| Chemistry |
| BACPAC I: Intermediates in Drug Substance Synthesis; Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation (Issued 2/2001, Posted 2/16/2001) |
| Botanical Drug Products (Issued 6/2004, Posted 6/9/2004) |
| Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products  (Issued 7/1997, Posted 7/28/1997) |
| Changes to an Approved NDA or ANDA (Issued 4/2004, Posted 4/7/2004) |
| Changes to an Approved NDA or ANDA: Questions and Answers (Issued 1/2001, Posted 1/22/2001) |
| Changes to an Approved NDA or ANDA; Specifications—Use of Enforcement Discretion for Compendial Changes (Issued 11/19/2004, Posted 11/19/2004) |
| Container Closure Systems for Packaging Human Drugs and Biologics (Issued 5/1999, Posted 7/6/1999) |
| Container Closure Systems for Packaging Human Drugs and Biologics—Questions and Answers (Issued 5/2002, Posted 5/10/2002) |
| Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products |
| Development of New Stereoisomeric Drugs (5/1/1992) (Post Date: 1/3/1996) |
| Drug Master Files (9/1/1989) |
| Current DMF Information (e.g. lists, addresses, guidances, etc.) |
| Drug Master Files for Bulk Antibiotic Drug Substances (Issued 11/1999, Posted 11/26/1999) |
| Environmental Assessment of Human Drug and Biologics Applications  (Issued 7/1998, Posted 7/24/98) |
| Format and Content of the Chemistry, Manufacturing and Controls Section of an Application*  (Issued 2/1987, Posted 3/2/1998) |
| Format and Content for the CMC Section of an Annual Report (9/1/1994) |
| INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information (Posted 5/20/2003) |
| IND Meetings for Human Drugs and Biologics Chemistry, Manufacturing, and Controls Information (Issued 5/2001, Posted 6/4/2001) |
| Monoclonal Antibodies Used as Reagents in Drug Manufacturing (Issued 3/2001, Posted 3/28/2001) |
| Nasal Spray and Inhalation Solution, Suspension, and Drug Products (Issued 7/2002, Posted 7/3/2002) |
| NDAs: Impurities in Drug Substances (Issued 2/2000, Posted 2/24/2000) |
| PAC-ATLS: Postapproval Changes—Analytical Testing Laboratory Sites  (Issued 4/28/1998, Posted 4/28/1998) |
| The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) (12/20/2000) |
| SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation |
| SUPAC-IR Questions and Answers about SUPAC-IR Guidance (2/18/1997) |
| SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms Manufacturing Equipment Addendum  (Issued 1/1999, Posted 2/25/1999) |
| SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation  (Issued 10/6/1997, Posted 10/6/1997) |
| SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation  (Issued 5/1997; Posted 6/16/1997) |
| Reviewer Guidance, Validation of Chromatographic Methods |
| Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products |
| Submission of Chemistry, Manufacturing, and Controls Information for Synthetic Peptide Substances |
| Submitting Documentation for the Manufacturing of and Controls for Drug Products* (Issued 2/1987, Posted 3/2/1998) |
| Submitting Documentation for the Stability of Human Drugs and Biologics*  (Issued 2/1987, Posted 3/2/1998) |
| Submitting Samples and Analytical Data for Methods Validation |
| Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances |
| Chemistry (Draft) |
| Analytical Procedures and Methods Validation.  (Issued 8/2000, Posted 8/30/2000) |
| Comparability Protocols—Chemistry, Manufacturing, and Controls Information (Issued 2/2003, Posted 2/20/2003) |
| Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals  (Posted 9/11/2003) |
| Drug Product: Chemistry, Manufacturing, and Controls Information   (Issued 1/2003, Posted 1/28/2003) |
| Drug Substance: Chemistry, Manufacturing, and Controls Information (Issued 1/2004, Posted 1/6/2004) |
| Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations (7/24/1999) |
| Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products (Issued 11/13/1998, Posted 11/19/1998, Posted 9/27/1999) |
| Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation.   (Issued 7/2002, Posted 8/20/2002) |
| Stability Testing of Drug Substances and Drug Products  (Issued 6/5/1998, Posted 6/8/1998) |
| SUPAC-SS: Nonsterile Semisolid Dosage Forms Manufacturing Equipment Addendum  (Issued 12/1998, Posted 1/5/1999) |
| Clinical/Antimicrobial |
| Antiretroviral Drugs Using Plasma HIV RNA Measurements—Clinical Considerations for Accelerated and Traditional Approval (Issued 10/2002, Posted 10/31/2002) |
| Clinical Development and Labeling of Anti-Infective Drug Products (Issued 10/1992, Posted 3/2/1998, Revised 2/12/2001) |
| Clinical Evaluation of Anti-Infective Drugs (Systemic)  (Issued 9/77, Posted 3/2/1998) |
| Clinical/Antimicrobial (Draft) |
| Acute Bacterial Exacerbation of Chronic Bronchitis—Developing Antimicrobial Drugs for Treatment  (Issued 7/22/1998, Posted 7/22/1998) |
| Acute Bacterial Meningitis—Developing Antimicrobial Drugs for Treatment  (Issued 7/22/1998, Posted 7/22/1998) |
| Acute Bacterial Sinusitis—Developing Antimicrobial Drugs for Treatment  (Issued 7/22/1998, Posted 7/22/1998) |
| Acute or Chronic Bacterial Prostatitis—Developing Antimicrobial Drugs for Treatment  (Issued 7/22/1998, Posted 7/22/1998) |
| Acute Otitis Media—Developing Antimicrobial Drugs for Treatment  (Issued 7/22/1998, Posted 7/22/1998) |
| Antiviral Drug Development—Conducting Virology Studies and Submitting the Data to the Agency (Issued 5/24/2005, Posted 5/24/2005) |
| Bacterial Vaginosis—Developing Antimicrobial Drugs for Treatment  (Issued 7/22/1998, Posted 7/22/1998) |
| Catheter-Related Bloodstream Infections—Developing Antimicrobial Drugs for Treatment (Issued 10/1999, Posted 10/18/1999) |
| Community-Acquired Pneumonia—Developing Antimicrobial Drugs for Treatment  (Issued 7/22/1998, Posted 7/22/1998) |
| Complicated Urinary Tract Infections and Pyelonephritis—Developing Antimicrobial Drugs for Treatment  (Issued 7/22/1998, Posted 7/22/1998) |
| Developing Antimicrobial Drugs—General Considerations for Clinical Trials  (Issued 7/22/1998, Posted 7/22/1998) |
| Empiric Therapy of Febrile Neutropenia—Developing Antimicrobial Drugs for Treatment  (Issued 7/22/1998, Posted 7/22/1998) |
| Evaluating Clinical Studies Of Antimicrobials In The Division Of Anti-Infective Drug Products (2/18/1997) |
| Inhalational Anthrax (Post Exposure)—Developing Antimicrobial Drugs (Issued 3/15/2002, Posted 3/15/2002) |
| Lyme Disease—Developing Antimicrobial Drugs for Treatment  (Issued 7/22/1998, Posted 7/22/1998) |
| Nosocomial Pneumonia—Developing Antimicrobial Drugs for Treatment  (Issued 7/22/1998, Posted 7/22/1998) |
| Role of HIV Drug Resistance Testing in Antiretroviral Drug Development (Issued 11/26/04, Posted 11/26/04) |
| Secondary Bacterial Infections of Acute Bronchitis—Developing Antimicrobial Drugs for Treatment  (Issued 7/22/1998, Posted 7/22/1998) |
| Streptococcal Pharyngitis and Tonsillitis—Developing Antimicrobial Drugs for Treatment  (Issued 7/22/1998, Posted 7/22/1998) |
| Uncomplicated and Complicated Skin and Skin Structure Infections—Developing Antimicrobial Drugs for Treatment  (Issued 7/22/1998, Posted 7/22/1998) |
| Uncomplicated Gonorrhea—Developing Antimicrobial Drugs for Treatment  (Issued 7/22/1998, Posted 7/22/1998) |
| Uncomplicated Urinary Tract Infections—Developing Antimicrobial Drugs for Treatment  (Issued 7/22/1998, Posted 7/22/1998) |
| Vaccinia Virus—Developing Drugs to Mitigate Complications from Smallpox Vaccination (Posted 3/8/2004) |
| Vulvovaginal Candidiasis—Developing Antimicrobial Drugs for Treatment  (Issued 7/22/1998, Posted 7/22/1998) |
| Clinical/Medical |
| Acceptance of Foreign Clinical Studies (Posted 3/12/2001) |
| Available Therapy (Posted 7/22/2004) |
| Calcium DTPA and Zinc DTPA Drug Products—Submitting a New Drug Application (Posted 8/13/2004) |
| Cancer Drug and Biological Products—Clinical Data in Marketing Applications (Posted 10/11/2001) |
| Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA) (Issued 1/1999, Posted 2/16/1999) |
| Clinical Development Programs for MDI and DPI Drug Products  (Issued 9/19/1994, Posted 3/2/1998) |
| Clinical Evaluation of Analgesic Drugs (Withdrawn per August 5, 2003, Federal Register Notice) |
| Clinical Evaluation of  Antacid Drugs  (Withdrawn per July 20, 2004, Federal Register notice.) |
| Clinical Evaluation of Anti-Inflammatory and Antirheumatic Drugs (adults and children) |
| Clinical Evaluation of Antianxiety Drugs  (Issued 9/77, Posted 3/2/1998) |
| Clinical Evaluation of Antidepressant Drugs  (Issued 9/77, Posted 3/2/1998) |
| Clinical Evaluation of Antidiarrheal Drugs  (Withdrawn per July 20, 2004, Federal Register notice.) |
| Clinical Evaluation of Antiepileptic Drugs (adults and children)  (Issued 1/1981, Posted 3/2/1998) |
| Clinical Evaluation of Gastric Secretory Depressant (GSD) Drugs  (Withdrawn per July 20, 2004, Federal Register notice.) |
| Clinical Evaluation of General Anesthetics  (Issued 5/1982, Posted 3/2/1998) |
| Clinical Evaluation of Hypnotic Drugs  (Issued 9/77, Posted 3/2/1998) |
| Clinical Evaluation of Laxative Drugs  (Withdrawn per July 20, 2004, Federal Register notice.) |
| Clinical Evaluation of Local Anesthetics  (Posted 3/2/1998) |
| Clinical Evaluation of Psychoactive Drugs in Infants and Children  (Posted 3/2/1998) |
| Clinical Evaluation of Radiopharmaceutical Drugs (Withdrawn per July 20, 2004, Federal Register notice.) |
| Collection of Race and Ethnicity Data in Clinical Trials (Issued 9/16/2005, Posted 9/16/2005) |
| Content and Format for Pediatric Use Supplements |
| Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products |
| Developing Medical Imaging Drug and Biological Products |
| Part 1: Conducting Safety Assessments (Issued 6/17/2004, Posted 6/17/2004) |
| Part 2: Clinical Indications (Issued 6/17/2004, Posted 6/17/2004) |
| Part 3: Design, Analysis, and Interpretation of Clinical Studies (Issued 6/17/2004, Posted 6/17/2004) |
| Development and Use of Risk Minimization Action Plans (Issued 3/24/2005, Posted 3/24/2005) |
| Establishing Pregnancy Exposure Registries (Issued 8/2002, Posted 9/20/2002) |
| Evaluating the Risks of Drug Exposure in Human Pregnancies (Issued 4/27/2005, Posted 4/27/2005) |
| FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products (Issued 12/1998, Posted 2/2/1999, posted 9/14/1999) |
| FDA Requirements for Approval of Drugs to Treat Non-Small Cell Lung Cancer  (Posted 3/2/1998) |
| FDA Requirements for Approval of Drugs to Treat Superficial Bladder Cancer (Withdrawn per July 20, 2004, Federal Register notice.) |
| Format and Content of the Clinical and Statistical Sections of an Application  (Issued 7/1988, Posted 5/21/1997) |
| Format and Content of the Summary for New Drug and Antibiotic Applications*  (Issued 2/1987, Posted 3/2/1998) |
| Formatting, Assembling and Submitting New Drug and Antibiotic Applications*  (Issued 2/1987, Posted 3/2/1998) |
| General Considerations for the Clinical Evaluation of Drugs |
| General Considerations for the Clinical Evaluation of Drugs in Infants and Children  (Issued 9/77, Posted 3/2/1998) |
| Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment (Issued 3/24/2005, Posted 3/24/2005) |
| Guidance for the Development of Vaginal Contraceptive Drugs (NDA)  (Posted 3/2/1998) |
| Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs: Waiver of IRB Requirements for Drug and Biological Product Studies (Issued 1/2006) |
| IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer (Revised 1/15/2004, Posted 1/15/2004) |
| Internal Radioactive Contamination—Development of Decorporation Agents (Issued 3/1/2006, Posted 3/1/2006) |
| Integration of Dose-Counting Mechanisms into MDI Drug Products (Issued 3/2003, Posted 3/12/2003) |
| Levothyroxine Sodium Tablets—In Vivo Pharmacokinetic and Bioavailability Studies and In Vitro Dissolution Testing (Issued 2/2001, Posted 3/8/2001) |
| Oncologic Drugs Advisory Committee Discussion on FDA Requirements for Approval of New Drugs for Treatment of Ovarian Cancer  (Posted 3/2/1998) |
| Oncologic Drugs Advisory Committee Discussion on FDA Requirements or Approval of New Drugs for Treatment of Colon and Rectal Cancer  (Posted 3/2/1998) |
| Premarketing Risk Assessment (Issued 3/24/2005; Posted 3/24/2005) |
| Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report (Issued 8/27/1997, Posted 8/27/1997) |
| Postmarketing Reporting of Adverse Drug Experiences  (Issued 3/1992, Posted 3/2/1998) |
| Preparation of Investigational New Drug Products (Human and Animal)  (Issued 11/1992, Posted 3/2/1998) |
| Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products  (Issued 5/14/1998, Posted 5/14/1998) |
| Prussian Blue Drug Products—Submitting a New Drug Application (Issued 1/2003, Posted 2/4/2003) |
| Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs  (Issued 7/22/1993, Posted 3/2/1998) |
| Study of Drugs Likely to be used in the Elderly  (Issued 11/1989, Posted 3/2/1998) |
| Submission of Abbreviated Reports and Synopses in Support of Marketing Applications (Issued 8/1999, Posted 9/13/1999) |
| The Use of Clinical Holds Following Clinical Investigator Misconduct |
| Clinical/Medical (Draft) |
| Acne Vulgaris: Developing Drugs for Treatment (Issued 9/16/2005, Posted 9/16/2005) |
| Allergic Rhinitis: Clinical Development Programs for Drug Products (Issued 6/2000, Posted 6/20/2000) |
| Chronic Cutaneous Ulcer and Burn Wounds—Developing Products for Treatment (Issued 6/2000, Posted 6/27/2000) |
| Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (Issued 7/07/1999, Posted 7/14/1999) |
| Clinical Evaluation of Lipid-Altering Agents (Issued 10/1990, Posted 2/18/1998) |
| Clinical Evaluation of Weight-Control Drugs (9/24/1996, Posted 2/18/1998) |
| Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics (Issued 4/1/2005, Posted 4/1/2005) |
| Development of Parathyroid Hormone for the Prevention and Treatment of Osteoporosis (Issued 5/2000, Posted 6/13/2000) |
| Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals (Issued 9/6/2002) |
| Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms—Recommendations for Clinical Evaluation (Issued 1/2003, Posted 1/30/2003) |
| Evaluation of the Effects of Orally Inhaled and Intranasal Corticosteroids on Growth in Children (Posted 11/6/2001) |
| Exercise-Induced Bronchospasm (EIB)—Development of Drugs to Prevent EIB (Issued 2/2002, Posted 2/19/2002) |
| Exocrine Pancreatic Insufficiency Drug Products—Submitting NDAs (Posted 4/27/2004) |
| Female Sexual Dysfunction: Clinical Development of Drug Products for Treatment (Issued 5/2000, Posted 5/18/2000) |
| Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention (Issued June 24, 2005, Posted June 27, 2005) |
| Guidance for Clinical Trial Sponsors On the Establishment and Operation of Clinical Trial Data Monitoring Committees (Issued 12/01/2005, Posted 2/07/2006) |
| Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research (3/31/2000) |
| Inhalation Drug Products Packaged in Semipermeable Container Closure Systems (Issued 7/2002, Posted 7/25/2002) |
| OTC Treatment of Herpes Labialis with Antiviral Agents (Issued 3/8/2000, Posted 3/8/2000) |
| Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (Issued 2/2/2006), Posted 2/2/2006) |
| Pediatric Oncology Studies In Response to a Written Request (Issued 6/2000, Posted 6/19/2000) |
| Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis (Issued 4/1994, Posted 2/18/1998) |
| Recommendations for Complying with the Pediatric Rule (21 CFR 314.55(a) and 601.27(a)) (Posted 12/1/2000) |
| Systemic Lupus Erythematosus—Developing Drugs for Treatment (Issued 3/28/2005, Posted 3/28/2005) |
| Clinical Pharmacology |
| Drug Metabolism/Drug Interaction Studies in the Drug Development Process: Studies In Vitro  (Issued 4/1997, Posted 4/8/1997) |
| Exposure-Response Relationships—Study Design, Data Analysis, and Regulatory Applications (Posted 5/5/2003) |
| Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application*  (Issued 2/1987, Posted 3/2/1998) |
| In Vivo Drug Metabolism/Drug Interaction Studies—Study Design, Data Analysis, and Recommendations for Dosing and Labeling (Issued 11/24/1999, Posted 11/24/1999) |
| Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling (Posted 5/30/2003) |
| Pharmacokinetics in Patients with Impaired Renal Function  (Issued 5/14/1998, Posted 5/14/1998) |
| Population Pharmacokinetics  (Issued 2/1999, Posted 2/10/1999) |
| Clinical Pharmacology (Draft) |
| Clinical Lactation Studies—Study Design, Data Analysis, and Recommendations for Labeling (Issued 2/7/05, Posted 2/8/05) |
| General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products  (Issued 11/1998, Posted 11/12/1998) |
| Pharmacokinetics in Pregnancy—Study Design, Data Analysis, and Impact on Dosing and Labeling (Issued 10/29/2004, Posted 10/29/2004) |
| Combination Products (Drug/Device/Biologic) |
| Draft and Final guidances can be found on the Office of Combination Products web site. |
| Compliance |
| A Review of FDA's Implementation of the Drug Export Amendments of 1986  (Issued 11/1989, Posted 3/2/1998) |
| Compressed Medical Gases (Issued 2/1989, Posted 3/10/1997) |
| Computerized Systems Used in Clinical Trials (Issued 4/1999, Posted 5/11/1999) |
| General Principles of Process Validation |
| Good Laboratory Practice Regulations Questions and Answers  (Posted 3/2/1998) |
| Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities—FDA Public Health Advisory (Issued and Posted 4/5/2001) |
| Guideline for Validation of Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices  (Posted 3/2/1998) |
| Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron  (Issued 6/27/1997, Posted 6/27/1997) |
| Monitoring of Clinical Investigations  (Posted 3/2/1998) |
| Nuclear Pharmacy Guideline Criteria for Determining When to Register as a Drug Establishment  (Posted 3/2/1998) |
| Pharmacy Compounding—Compliance Policy Guide  (Issued 5/2002, Posted 3/12/2004) |
| Possible Dioxin/PCB Contamination of Drug and Biological Products (Issued 8/23/1999, Posted 8/23/1999) |
| Prescription Drug Marketing Act—Donation of Prescription Drug Samples to Free Clinics (Issued 3/2006, Posted 3/13/2006) |
| Street Drug Alternatives (Issued 3/2000, Posted 3/31/2000) |
| Compliance (Draft) |
| Bar Code Label Requirements—Questions and Answers. (Issued 6/7/2005, Posted 6/7/2005) |
| Computerized Systems Used in Clinical Trials (Posted 9/29/2004) |
| Current Good Manufacturing Practice for Medical Gases (Posted 5/6/2003) |
| Expiration Dating of Unit-Dose Repackaged Drugs: Compliance Policy Guide (5/27/2005) |
| Guidance for IRBs, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research (21 CFR 50.24) Draft released for comment 3/30/2000 (5/12/2000) |
| Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production (Issued 9/30/1998, Posted 9/30/1998) |
| Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients  (Issued 4/17/1998, Posted 4/17/1998) |
| Marketed Unapproved Drugs—Compliance Policy Guide (Issued 10/15/2003, Posted 10/17/2003) |
| PET Drug Products—Current Good Manufacturing Practice (CGMP) (Issued 9/15/2005, Posted 9/15/2005) |
| Drug Safety |
| Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review (Issued 2/2005, Posted 2/2005) |
| Drug Safety Draft |
| FDA's “Drug Watch” for Emerging Drug Safety Information (Issued 5/5/2005; Posted 5/5/2005) |
| Questions and Answers (Qs & As) |
| Electronic Submissions |
| Part 11, Electronic Records; Electronic Signatures—Scope and Application (Posted 9/3/2003) |
| Providing Regulatory Submissions in Electronic Format—ANDAs (Issued 6/2002, Posted 6/27/2002) |
| Providing Regulatory Submissions in Electronic Format—Content of Labeling (Issued 4/20/2005, Posted 4/20/2005) |
| Providing Regulatory Submissions in Electronic Format—Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.  To ensure you have the most recent versions of the specifications referenced in this document, check the appropriate center's guidance Web page. For CBER, this Web site is 
                            
                            . For CDER, this Web site is 
                            
                            .  (Issued 10/18/2005, Posted 10/18/2005) |
| Regulatory Submissions in Electronic Format; General Considerations  (Issued 1/1999, Posted 1/27/1999) |
| Regulatory Submissions in Electronic Format; New Drug Applications  (Issued 1/1999, Posted 1/27/1999) |
| SPL Standard for Content of Labeling Technical Qs & As ( Issued 12/2005, Posted 12/8/2005) |
| Example of an Electronic New Drug Application Submission (Posted 2/17/1999). |
| Electronic Submissions Draft |
| Providing Regulatory Submissions in Electronic Format—Annual Reports for NDAs and ANDAs (Posted 8/27/2003) |
| Providing Regulatory Submissions in Electronic Format—General Considerations (Issued 10/2003, Posted 10/22/2003) |
| Providing Regulatory Submissions in Electronic Format—Postmarketing Expedited Safety Reports (Issued 5/2001, Posted 5/3/2001) |
| Providing Regulatory Submissions in Electronic Format—Postmarketing Periodic Adverse Drug Experience Reports (Posted 6/23/3003) |
| Providing Regulatory Submissions in Electronic Format—Prescription Drug Advertising and Promotional Labeling (Issued 1/2001, Posted 1/30/2001) |
| Generics |
| 180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same Day (Issued 7/2003, Posted 7/31/2003) |
| Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAs (Posted 12/12/2000) |
| ANDA's: Impurities in Drug Substances (Issued 11/1999, Posted 12/2/1999) |
| Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (Posted 3/27/2000) |
| Handling and Retention of BA and BE Testing Samples (5/25/2004) |
| Letter announcing that the OGD will now accept the ICH long-term storage conditions as well as the stability studies conducted in the past.  (Posted 3/2/1998) |
| Letter describing efforts by the CDER and the ORA to clarify the responsibilities of CDER chemistry review scientists and ORA field investigators in the new and abbreviated drug approval process in order to reduce duplication or redundancy in the process  (Posted 3/2/1998) |
| Letter on incomplete Abbreviated Applications, Convictions Under GDEA, Multiple Supplements, Annual Reports for Bulk Antibiotics, Batch Size for Transdermal Drugs, Bioequivalence Protocols, Research, Deviations from OGD Policy  (Posted 3/2/1998) |
| Letter on the Provision of new information pertaining to new bioequivalence guidelines and refuse-to-file letters  (Posted 3/2/1998) |
| Letter on the provision of new procedures and policies affecting the generic drug review process  (Posted 3/2/1998) |
| Letter on the request for cooperation of regulated industry to improve the efficiency and effectiveness of the generic drug review process, by assuring the completeness and accuracy of required information and data submissions  (Posted 3/2/1998) |
| Letter on the response to 12/20/1984 letter from the Pharmaceutical Manufacturers Association about the Drug Price Competition and Patent Term Restoration Act  (Posted 3/2/1998) |
| Letter to all ANDA and AADA applicants about the Generic Drug Enforcement Act of 1992 (GDEA), and the Office of Generic Drugs intention to refuse-to-file incomplete submissions as required by the new law  (Posted 3/2/1998) |
| Letter to regulated industry notifying interested parties about important detailed information regarding labeling, scale-up, packaging, minor/major amendment criteria and bioequivalence requirements  (Posted 3/2/1998) |
| Major, Minor, and Telephone Amendments to Abbreviated New Drug Applications (Issued 12/2001, Posted 12/20/2001) |
| Potassium Chloride Modified-Release Tablets and Capsules: In Vivo Bioequivalence and In Vitro Dissolution Testing (Issued 10/25/2005; Posted 10/25/2005) |
| Revising ANDA Labeling Following Revision of the RLD Labeling (Issued 4/26/2000, 4/26/2000) |
| Variations in Drug Products that May Be Included in a Single ANDA  (Issued 12/1998, Posted 1/26/1999) |
| Generics (Draft) |
| ANDAs: Impurities in Drug Products (Issued 8/26/2005, Posted 8/26/2005) |
| ANDAs: Impurities in Drug Substances (Issued 1/28/2005, Posted 1/28/2005) |
| ANDAs:  Pharmaceutical Solid Polymorphism (Issued 12/17/2004, Posted 12/17/2004) |
| Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003—Questions and Answers (Issued 10/2004, Posted 11/3/2004) |
| Good Review Practices (GRPs) |
| Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review (Posted 2/18/2005) |
| Pharmacology/Toxicology Review Format (Posted 5/9/2001) |
| Good Review Practices (GRPs) (Draft) |
| Industry Letters |
| Continuation of a series of letters communicating interim and informal generic drug policy and guidance.  Availability of Policy and Procedure Guides, and further operational changes to the generic drug review program  (Posted 3/2/1998) |
| Fifth of a series of letters providing informal notice about the Act, discussing the statutory mechanism by which ANDA applicants may make modifications in approved drugs where clinical data is required  (Posted 3/2/1998) |
| Fourth of a series of letters providing informal notice to all affected parties about policy developments and interpretations regarding the Act.  Three year exclusivity provisions of Title I  (Posted 3/2/1998) |
| Implementation of the Drug Price Competition and Patent Term Restoration Act.   Preliminary Guidance  (Posted 3/2/1998) |
| Implementation Plan USP injection nomenclature  (Posted 3/2/1998) |
| Seventh of a series of letters about the Act providing guidance on the “130-day exclusivity” provision of section 505(j)(4)(B)(iv) of the FD&C  (Posted 3/2/1998) |
| Sixth of a series of informal notice letters about the Act discussing 3- and 5-year exclusivity provisions of sections 505(c)(3)(D) and 505(j)(4)(D) of the FD&C Act  (Posted 3/2/1998) |
| Supplement to 10/11/1984 letter about policies, procedures and implementation of the Act (Q&A format)  (Posted 3/2/1998) |
| Third of a series of letters regarding the implementation of the Act  (Posted 3/2/1998) |
| Year 2000 Letter from Dr. Janet Woodcock (10/19/98) |
| International Conference on Harmonisation |
| Safety |
| S1A The Need for Long-term Rodent Carcinogenicity Studies of Pharmaceuticals |
| S1B Testing for Carcinogenicity of Pharmaceuticals  (Issued 2/28/1998, Posted 3/24/1998) |
| S1C Dose Selection for Carcinogenicity Studies of Pharmaceuticals |
| S1C(R) Guidance on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on a Limit Dose and Related Notes  (Issued 12/4/1997, Posted 12/11/1997) |
| S2A Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals |
| S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals  (Issued 11/21/1997, Posted 5/4/1998) |
| S3A Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies |
| S3B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies |
| S4A Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing) Posted 6/25/99 |
| S5A Detection of Toxicity to Reproduction for Medicinal Products  (Issued 9/1994, Posted 4/23/1997) |
| S5B Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility |
| S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals  (Issued 11/1997, Posted 11/18/1997) |
| S7A Safety Pharmacology Studies for Human Pharmaceuticals (Issued 7/2001, Posted 7/12/2001) |
| S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals (Issued 10/19/2005, Posted 10/19/2005). |
| Joint Safety/Efficacy (Multidisciplinary) |
| M2 eCTD: Electronic Common Technical Document Specification (Posted 4/1/2003) |
| M2: eCTD Specification Questions and Answers and Change Requests (Posted 3/14/05) |
| Companion Document: Current Q & As and Change Requests (Issued 1/6/2006; Posted 1/6/2006) |
| M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals  (Issued 11/1997, Posted 11/25/1997) |
| M4: Common Technical Document for the Registration of Pharmaceuticals for Human Use (Posted 10/15/2001) |
| M4: Organization of the CTD |
| M4 Granularity Annex (Issued 10/18/2005, Posted 10/18/2005) |
| M4:  The CTD—General Questions and Answers (Issued 12/04, Posted 12/22/2004) |
| M4: The CTD—Quality |
| M4: The CTD—Quality Questions and Answers /Location Issues (Issued 6/2004, Posted 6/8/2004) |
| M4: The CTD—Efficacy |
| M4: The CTD—Efficacy Questions and Answers (Issued 12/2004,  Posted 12/22/2004) |
| M4: The CTD—Safety |
| M4: The CTD—Safety Appendices |
| M4: The CTD—Safety Questions and Answers (Issued 2/2003, Posted 2/4/2003) |
| Efficacy |
| E1A The Extent of Population Exposure to Assess Clinical Safety: For Drugs Intended for Long-term Treatment of Non-Life-Threatening Conditions |
| E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting |
| E2B International Conference on Harmonisation; Guidance on Data Elements for Transmission of Individual Case Safety Reports (Issued 1/15/1998, Posted 1/15/1998) |
| E2BM Data Elements for Transmission Of Individual Case Safety Reports  (Issued 4/2002, Posted 4/4/2002) |
| E2B(M) Questions and Answers (Revised 3/09/2005,  Posted, 3/16/2005) |
| E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs  (Issued 5/19/1997, Posted 3/19/1998) |
| E2C Addendum to ICH E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs (Posted 2/5/2004) |
| E2E Pharmacovigilance Planning (Issued 3/31/05; Posted 3/31/05) |
| E3 Structure and Content of Clinical Study Reports |
| E4 Dose-Response Information to Support Drug Registration |
| E5 Ethnic Factors in the Acceptability of Foreign Clinical Data |
| E5 Questions and Answers (Issue 6/2004, Posted 6/4/2004) |
| E6 Good Clinical Practice: Consolidated Guideline  Spanish Version (Issued 5/9/1997, Posted 3/19/1998) |
| E7 Studies in Support of Special Populations: Geriatrics |
| E8 General Considerations for Clinical Trials  (Issued 12/1997, Posted 12/17/1997) |
| E9 Statistical Principles for Clinical Trials  (9/1/1998) |
| E10 Choice of Control Group and Related Issues in Clinical Trials (Issued 5/2001, Posted 5/11/2001) |
| E11 Clinical Investigation of Medicinal Products in the Pediatric Population (Issued 12/2000, Posted 12/14/2000) |
| E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs (Issued 10/19/2005, Posted 10/19/2005) |
| Quality |
| Q1A(R2) Stability Testing of New Drug Substances and Products (Issued 11/2003, Posted 11/20/2003) |
| Q1B Photostability Testing of New Drug Substances and Products (Issued 11/1996, Reposted 7/7/1998) |
| Q1C Stability Testing for New Dosage Forms  (Issued 5/9/1997, Posted 3/19/1998) |
| Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products (Issued 1/2003, Posted 1/15/2003) |
| Q1E Evaluation of Stability Data (Issued 6/2004, Posted 6/7/2004) |
| Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV, revision 1 (7/1/2004) |
| Q2A Text on Validation of Analytical Procedures |
| Q2B Validation of Analytical Procedures: Methodology  (Issued 5/19/1997, Posted 3/19/1997) |
| Q3A Impurities in New Drug Substances (Issued 2/10/2003, Posted 2/10/2003) |
| Q3B(R) Impurities in New Drug Products (Issued 11/2003, Posted 11/13/2003) |
| Q3C Impurities: Residual Solvents or Adobe Acrobat version  (Issued 12/24/1997, Posted 12/30/1997) |
| Q3C Tables and List (Posted 11/12/2003) |
| Appendix 4, Appendix 5, and Appendix 6 (Appendices were issued with the Q3C draft guidance documents) |
| Maintenance Procedures for Updating (Posted 2/11/2002) |
| Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin (Posted 9/1998) |
| Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products |
| Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products |
| Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products; Availability  (Issued 9/21/1998, Posted 9/21/1998) |
| Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process (Issued 6/2005, Posted 6/29/2005) |
| Q6A International Conference on Harmonisation; Guidance on Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances. (12/29/2000) |
| Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (Issued 8/1999, Posted 12/14/2001) |
| Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (Issued 8/2001, Posted 9/24/2001] |
| International Conference on Harmonisation (Draft) |
| Efficacy |
| E2B(R) Clinical Safety Data Management:  Data Elements for Transmission of Individual Case Safety Reports (Issued 9/30/2005, Posted 9/30/2005) |
| E2D Postapproval Safety Data Management: Definitions and Standards for Expedited Reporting (Posted 9/12/2003) |
| Principles for Clinical Evaluation of New Antihypertensive Drugs. (Issued 8/2000, Posted 8/8/2000) |
| Joint Safety/Efficacy (Multidisciplinary) (Draft) |
| International Conference on Harmonisation; Draft Guidance on M5 Data Elements and Standards for Drug Dictionaries (Issued 9/2005, Posted 9/2/2005) |
| Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (Issued 9/2001, Posted 9/5/2001) |
| Quality |
| Q8 Pharmaceutical Development (Issued 2/7/2005, Posted 2/8/2005) |
| Q9 Quality Risk Management (Issued 8/5/2005, Posted 8/5/2005) |
| Safety |
| S8 Immunotoxicity Studies for Human Pharmaceuticals (Issued 2/7/05, Posted 2/8/05) |
| Investigational New Drug Applications |
| Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs |
| Labeling |
| Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products—Content and Format (Issued 1/18/2006; Posted 1/18/2006) |
| Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products—Content and Format (Issued 1/18/2006; Posted 1/18/2006) |
| Content and Format for Geriatric Labeling (Issued 10/2001, Posted 10/4/2001) |
| Labeling (Draft) |
| Labeling for Combined Oral Contraceptives (Issued 3/2/2004, Posted 3/4/2004) |
| Labeling for Human Prescription Drug and Biological Products—Implementing the New Content and Format Requirements (Issued 1/18/2006; Posted 1/18/2006) |
| Labeling Guidance for OTC Topical Drug Products for the Treatment of Vaginal Yeast Infections (Vulvovaginal Candidiasis)  (Issued 6/1998, Posted 7/20/1998) |
| Noncontraceptive Estrogen Drug Products for the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms—Recommended Prescribing Informtion for Health Care Providers and Patient Labeling (Issued 11/15/2005, Posted 11/15/2005) |
| Referencing Discontinued Labeling for Listed Drugs in Abbreviated New Drug Applications (Issued 10/2000, Posted 10/25/2000) |
| Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products—Content and Format (Issued 1/18/2006; Posted 1/18/2006) |
| Microbiology |
| Format and Content of the Microbiology Section of an Application* |
| Modernization Act of 1997 |
| Changes to an Approved NDA or ANDA (Issued 4/2004, Posted 4/7/2004) |
| Classifying Resubmissions in Response to Action Letters  (Issued 5/14/1998, Posted 5/14/1998) |
| Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act (Issued 11/1998, Posted 11/20/1998) |
| Fast Track Drug Development Programs—Designation, Development, and Application Review (Posted 7/22/2004) |
| Appendix 2;  Appendix 3  consisting of Mapp 6020.3 and SOPP 8405; and Appendix 4  [Appendices are scanned copies, which will be replaced by final versions] (Issued 11/17/1998, Posted 11/17/1998) |
| Formal Dispute Resolution: Appeals Above the Division Level (Issued 2/2000, Posted 3/6/2000) |
| Formal Meetings With Sponsors and Applicants for PDUFA Products (Issued 2/2000, Posted 3/6/2000) |
| Implementation of Section 120 of the Food and Drug Administration Modernization Act of 1997—Advisory Committees (Issued 10/1998, Posted 11/02/98) |
| Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997—Elimination of Certain Labeling Requirements  (Issued 7/1998, Posted 7/20/98) |
| Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (Issued 3/2002, Posted 3/18/2002) |
| National Uniformity for Nonpresciption Drugs—Ingredient Listing for OTC Drugs  (Issued 4/1998, Posted 5/5/1998) |
| Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products  (Issued 5/14/1998, Posted 5/14/1998) |
| Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act (Issued 9/1999, Posted 10/4/1999) |
| Frequently Asked Questions on Pediatric Exclusivity (505A), The Pediatric “Rule,” and Their Interaction (Posted 7/27/1999) |
| Repeal of Section 507 of the Federal Food, Drug and Cosmetic Act  (Revised 5/1998, Posted 6/12/1998) |
| Standards for Prompt Review of Efficacy Supplements  (Issued 5/15/1998, Posted 5/15/1998) |
| Submission of Abbreviated Reports and Synopses in Support of Marketing Applications (Issued 8/1998, Posted 9/15/98) |
| Submitting and Reviewing Complete Responses to Clinical Holds (Revised) (Issued 10/2000, Posted 10/25/2000 |
| Women and Minorities Guidance Requirements  (Issued 7/20/1998, Posted 11/25/1998) |
| Modernization Act of 1997 (Draft) |
| Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (Issued 1/2004, Posted 1/27/2004) |
| PET Drug Applications—Content and Format for NDAs and ANDAs (Issued 3/7/2000, Posted 3/7/2000) |
| Sample formats for chemistry, manufacturing, and controls sections |
| Sample formats for labeling |
| Sample formats for Form FDA 356h |
| Sample formats for user fee Form FDA 3397 |
| Reports on the Status of Postmarketing Studies—Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 (Posted 4/4/2001) |
| Over-the-Counter (OTC) Guidances |
| Enforcement Policy on Marketing OTC Combination Products (CPG 7132b.16)  (Posted 3/2/1998) |
| General Guidelines for OTC Combination Products  (Posted 3/2/1998) |
| Labeling OTC Human Drug Products Using a Column Format (Issued 12/2000, Posted 12/18/2000) |
| Labeling OTC Human Drug Products Updating Labeling in RLDs and ANDAs |
| Example Drug Facts Labels |
| Acetaminophen 120 mg in a Suppository Dosage Form |
| Acetaminophen 325 mg in a Suppository Dosage Form |
| Acetaminophen 650 mg in a Suppository Dosage Form |
| Cimetidine 200 mg in a Tablet Dosage Form |
| Clemastine Fumerate 1.34 mg in a Tablet Dosage Form |
| Doxylamine Succinate 25 mg Tablet Dosage Form |
| Ibuprofen 200 mg in a Tablet/Capsule Dosage Form |
| Loperamide HCl in a Liquid Dosage Form |
| Loperamide HCl in a Tablet/Caplet Dosage Form |
| Miconazole Nitrate Vaginal Products |
| Minoxidil Topical Solution 2% for Men and Women |
| Minoxidil Topical Solution 5% for Men |
| Naproxen Sodium 220 mg in a Tablet/Caplet/Gelcap Dosage Form |
| Pseudoephedrine HCl Extended-Release Tablets 120 mg |
| Upgrading Category III Antiperspirants to Category I (43 FR 46728-46731)  (Posted 3/2/1998) |
| Over-the-Counter (OTC) Draft |
| Labeling OTC Human Drug Products Questions and Answers (Issued 1/2005, Posted 1/12/05 |
| Labeling OTC Human Drug Products—Submitting Requests for Exemptions and Deferrals (Issued 12/2000, Posted 12/18/2000) |
| Labeling OTC Human Drug Products (Small Entity Compliance Guide) (Issued 12/2004, Posted 6/8/2005) |
| Labeling OTC Human Drug Products Updating Labeling in ANDAs (2/21/2001) |
| Additional examples 1  (3/19/2001) |
| Additional examples 2  (3/26/2001) |
| Additional examples 3  (3/26/2001) |
| Time and Extent Applications (Issued 2/2004, Posted 2/11/2004) |
| Pharmacology/Toxicology |
| Carcinogenicity Study Protocol Submissions (Issued 5/22/2002) |
| Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products |
| Developing Medical Imaging Drug and Biological Products |
| Part 1: Conducting Safety Assessments (Issued 6/17/2004, Posted 6/17/2004) |
| Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers (Issued 7/21/2005, Posted 7/21/2005. |
| Exploratory IND Studies (Issued 1/12/2006; Posted 1/12/2006) |
| Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application*  (Posted 3/2/1998) |
| Immunotoxicology Evaluation of Investigational New Drugs (Issued 10/2002, Posted 10/31/2002) |
| Nonclinical Pharmacology/Toxicology Development of Topical Drugs Intended to Prevent the Transmission of Sexually Transmitted Diseases (STD) and/or for the Development of Drugs Intended to Act as Vaginal Contraceptives |
| Nonclinical Safety Evaluation of Pediatric Drug Products (Issued 2/14/2006, Posted 2/14/2006) |
| Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients (Issued 05/18/2005, Posted 05/18/2005) |
| Photosafety Testing (Posted 5/7/2003) |
| Recommended Approaches to Integration of Genetic Toxicology Study Results (Issued 1/3/2006, Posted 1/3/2006). |
| Reference Guide for the Nonclinical Toxicity Studies of Antivial Drugs Indicated for the Treatment of N/A Non-Life Threatening Disease Evaluation of Drug Toxicity Prior to Phase I Clinical Studies  (Posted 3/2/1998) |
| Single Dose Acute Toxicity Testing for Pharmaceuticals |
| Pharmacology/Toxicology Draft |
| Integration of Study Results to Assess Concerns about Human Reproductive and Developmental Toxicities (Issued 11/2001, Posted 11/9/2001) |
| Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals (Issued 6/17/2005; Posted 6/17/2005) |
| Nonclinical Safety Evaluation of Drug Combinations (Issued 1/26/05, Posted 1/26/05) |
| Safety Testing of Drug Metabolites (Issued 6/2005, Posted 6/3/2005) |
| Statistical Aspects of the Design, Analysis, and Interpretation of Chronic Rodent Carcinogenicity Studies of Pharmaceuticals (Issued 5/2001, Posted 5/7/2001) |
| Procedural |
| 180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act  (Issued 6/1998, Posted 6/22/1998) |
| Continuous Marketing Applications: Pilot 1—Reviewable Units for Fast Track Products Under PDUFA (Posted 10/1/2003) |
| Continuous Marketing Applications: Pilot 2—Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA (Posted 10/1/2003) |
| Paperwork Reduction Act Burden Statement (Posted 7/27/2004) |
| Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (Posted 3/27/2000) |
| Disclosure of Materials Provided to Advisory Committees in Connection with Open Advisory Committee Meetings Convened by the Center for Drug Evaluation and Research Beginning on January 1, 2000 (Issued 11/1999, Posted 11/29/1999) |
| Drug Products Containing Ensulizole, Hypromellose, Meradimate, Octinoxate, and Octisalate—Labeling Enforcement Policy (Posted 6/3/2003) |
| Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act (Issued 11/1998, Posted 11/20/1998) |
| Fast Track Drug Development Programs—Designation, Development, and Application Review (Posted 1/12/2006) |
| Appendix 2 ;  Appendix 3  consisting of Mapp 6020.3 and SOPP 8405;and Appendix 4  [Appendices are scanned copies, which will be replaced by final versions 11/18] (Issued 11/17/1998, Posted 11/17/1998) |
| FDA Export Certicates (Issued 7/2004, Posted 7/13/2004) |
| Financial Disclosure by Clinical Investigators (3/27/2001) |
| Formal Dispute Resolution: Appeals Above the Division Level (Issued 2/2000, Posted 3/6/2000) |
| Formal Meetings With Sponsors and Applicants for PDUFA Products (Issued 2/2000, Posted 3/6/2000) |
| Good Review Management Principles and Practices for PDUFA Products (Issued 3/2005; Posted 3/30/2005) |
| Guidance for FDA Staff: The Leveraging Handbook; An Agency Resource for Effective Collaborations (Revised 6/2003) |
| Implementation of Section 120 of the Food and Drug Administration Modernization Act of 1997—Advisory Committees (Issued 10/1998, Posted 11/02/98) |
| Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997—Elimination of Certain Labeling Requirements  (Issued 7/1998, Posted 7/20/98) |
| Independent Consultants for Biotechnology Clinical Trial Protocols (Issued 8/18/2004, Posted 8/192/2004) |
| Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (Issued 3/2002, Posted 3/18/2002) |
| Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act (Issued 11/2001) |
| Levothyroxine Sodium Products Enforcement of August 14, 2001 Compliance Date and Submission of New Applications (Issued 7/2001, Posted 7/12/2001) |
| National Uniformity for Nonpresciption Drugs—Ingredient Listing for OTC Drugs  (Issued 4/1998, Posted 5/5/1998) |
| Pharmacogenomic Data Submissions (Issued 3/2005, Posted 3/22/2005) |
| Examples of Voluntary Submissions or Submissions Required Under 21 CFR 312, 314, or 601 (Issued 3/2005, Posted 3/22/2005) |
| Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies (Issued 12/2001, Posted 12/10/2001) |
| KI in Radiation Emergencies—Questions and Answers (Issued 12/20/2002, Posted 12/23/2002) |
| Potassium Iodide Tablets—Shelf Life Extension (Posted 3/8/2004) |
| Reduction of Civil Money Penalties for Small Entities (Issued 3/20/2001) |
| Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act (Issued 9/1999, Posted 10/4/1999) |
| Refusal to File  (Issued 7/12/1993, Posted 11/26/99) |
| Repeal of Section 507 of the Federal Food, Drug and Cosmetic Act  (Revised 5/1998, Posted 6/12/1998) |
| Reports on the Status of Postmarketing Study Commitments—Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 (Issued 2/15/2006; Posted 2/15/2006) |
| Special Protocol Assessment (Issued 5/2002, Posted 5/16/2002) |
| Standards for Prompt Review of Efficacy Supplements  (Issued 5/15/1998, Posted 5/15/1998) |
| Submitting and Reviewing Complete Responses to Clinical Holds (Revised) (Issued 10/2000, Posted 10/25/2000) |
| Procedural Draft |
| Applications Covered by Section 505(b)(2) (Issued 10/1999, Posted 12/7/1999) |
| Disclosing Information Provided to Advisory Committees in Connection with Open Advisory Committee Meetings Related to the Testing or Approval of New Drugs and Convened by the Center for Drug Evaluation and Research, Beginning on January 1, 2000 (Issued 12/1999, Posted 12/22/1999) |
| Disclosure of Conflicts of Interest for Special Government Employees Participating in FDA Product Specific Advisory Committees (2/14/2002) |
| Emergency Use Authorization of Medical Products; Availability (Issued 7/5/2005; Posted 7/5/2005. |
| Fixed Dose Combination and Co-Packaged Drug Products for Treatment of HIV (5/17/2004) |
| Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution (5/14/2001) |
| How to Comply with the Pediatric Research Equity Act (Posted 9/7/2005) |
| Independent Consultants for Biotechnology Clinical Trial Protocols (Posted 5/7/2003) |
| Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (Issued 1/2004, Posted 1/27/2004) |
| PET Drug Applications—Content and Format for NDAs and ANDAs (Issued 3/7/2000, Posted 3/7/2000) |
| Sample formats for chemistry, manufacturing, and controls sections |
| Sample formats for labeling |
| Sample formats for Form FDA 356h |
| Sample formats for user fee Form FDA 3397 |
| Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines  (Issued 3/2001, Posted 3/9/2001) |
| Submitting Debarment Certification Statements  (Issued 10/2/98, Posted 10/2/98) |
| Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (Issued 9/2001, Posted 9/5/2001) |
| The Use of Clinical Holds Following Clinical Investigator Misconduct   (Issued 4/2002, Posted 8/26/2002) |
| Useful Written Consumer Medication Information (CMI) (Issued 5/25/2005, Posted 5/25/2005) |
| Using a Centralized IRB Review Process in Multicenter Clinical Trials (Issued 3/25/2005, Posted 3/25/2005) |
| Small Entity Compliance Guides |
| Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation—Small Entity Compliance Guide (Posted 11/7/2001) |
| Small Entity Compliance Guides (Draft) |
| Labeling OTC Human Drug Products (Small Entity Compliance Guide) (Issued 12/2004, Posted 6/8/2005) |
| User Fees |
| Classifying Resubmissions in Response to Action Letters  (Issued 5/14/1998, Posted 5/14/1998) |
| Fees-Exceed-the-Costs Waivers Under the Prescription Drug User Fee Act (Issued 6/1999, Posted 6/25/99) |
| Guidance for Industry and FDA Staff: Application User Fees for Combination Products.  (Issued 4/2005, Posted 5/3/2005) |
| Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act (Issued 11/2001) |
| Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees (Issued 12/30/2004, Posted 12/30/2004) |
| User Fees (Draft) |
| Attachment G—Draft Interim Guidance Document for Waivers of and Reductions in User Fees  (7/16/1993) |
| User Fee Waivers for FDC and Co-Packaged HIV Drugs for PEPFAR (Issued 4/15/2005, Posted 4/15/2005) |
| Also see Current Good Manufacturing Practice Regulations |
| Enforcement of the Postmarketing Adverse Drug Experience Reporting Regulations (Posted 8/11/1997) |

**IV.  Center for Devices and Radiological Health (CDRH)**

For information on a specific guidance document or to obtain a hard copy, contact: Division of Small Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 1-800-638-2041 or 301-443-6597, *http://www.fda.gov/cdrh/guidance.html* .

The following is a list of CDRH guidance documents that have been withdrawn from January 5, 2005, to January 5, 2006.

| Title of Document | Date of Issuance | Date of Withdrawal |
| --- | --- | --- |
| Methods for Conducting Recall Effectiveness Checks | June 16, 1978 | January 2006 |
| Guidance for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Criteria for Waiver; Draft Guidance for Industry and FDA | March 1, 2001 | September 7, 2005 |
| Guidance for Industry; In Vitro Diagnostic C-Reactive Protein Immunological Test System | July 20, 1998 | September 22, 2005 |
| Guidance for Over-the-Counter (OTC) Ovulation Predictor 510(k)s | July 22, 2000 | September 7, 2005 |
| Draft Review Criteria for Nucleic Acid Amplification Based In Vitro Diagnostic Devices for Direct Detection of Infectious Microorganisms | June 14, 1993 | December 8, 2005 |
| CDRH Interim Regulatory Policy for External Penile Rigidity Devices | September 10, 1997 | January 2005 |
| Guidance for Neurological Embolization Devices | November 1, 2000 | January 2005 |
| Class II Special Controls Guidance Document:  Dental Bone Grafting Material Devices | Draft of this document was issued on June 30, 2004 | Final issued on:  April 28, 2005 |
| Class II Special Controls Guidance Document:  Vascular and Neurovascular Embolization Devices | Draft of this document was issued on February 25, 2004 | Final issued on:  December 29, 2004 |
| Class II Special Controls Guidance Document:   External Penile Rigidity Devices | Draft of this document was issued March 17, 2004 | Final issued on:  December 28, 2004 |

The following is a copy of a list of current CDRH guidance documents obtained from the FDA Web site as of March14, 2006.

|  |
| --- |
| (1) A Guide for the Submission of Abbreviated Radiation Safety  Reports on Image Receptor Support Devices for Mammographic X-Ray  Systems 979 03/01/1996 |
| (2) Abbreviated Reports on Radiation Safety of Non-Medical  Ultrasonic Products 951 08/01/1995 |
| (3) Compliance Program for Field Compliance Testing of Cabinet X-Ray  Equipment (CP 7386.004); Final Guidance for Industry and FDA Staff  57 02/26/2001 |
| (4) Compliance Program Guidance Manual: Field Implementation of the  Sunlamp and Sunlamp Product Performance Standard, as amended; Final  Guidance for Industry and FDA 75 10/06/2001 |
| (5) Frequently Asked Questions (FAQs) on the Status of Reprocessed  Single Use Devices (SUDs) that receive a Not Substantially  Equivalent (NSE) Letter—Guidance for Industry and FDA Staff 1544  11/08/2004 |
| (6) Guidance for the Submission of Cabinet X-Ray System Reports  Pursuant to 21-CFR 1020.40 241 02/01/1975 |
| (7) Guidance on the Department of Defense Exemption from the FDA  Performance Standard for Laser Products; Guidance for Industry and  FDA 1412 07/12/2002 |
| (8) Guide for Preparing Abbreviated Reports of Microwave and RF  Emitting Electronic Products Intended for Medical Use 399 09/01/1996 |
| (9) Guide for Preparing Annual Reports for Ultrasonic Therapy  Products 261 09/01/1996 |
| (10) Guide for Preparing Annual Reports on Radiation Safety Testing  of Electronic Products (General) 243 10/01/1987 |
| (11) Guide for Preparing Annual Reports on Radiation Safety Testing  of Mercury Vapor Lamps 263 09/01/1995 |
| (12) Guide for Preparing Annual Reports on Radiation Safety Testing  of Sunlamps and Sunlamp Products 262 09/01/1995 |
| (13) Guide for Preparing Product Reports for Medical Ultrasound  Products 960 09/01/1996 |
| (14) Guide for Preparing Product Reports for Ultrasonic Therapy  Products (physical therapy only) 249 08/01/1996 |
| (15) Guide for Preparing Product Reports on Sunlamps and Sunlamp  Products (21-CFR 1002) 279 09/01/1995 |
| (16) Guide for Preparing Reports on Radiation Safety of Microwave  Ovens 239 03/01/1985 |
| (17) Guide for Submission of Information on Accelerators Intended to  Emit X-Radiation Required Pursuant to 21-CFR 1002.10 235 04/01/1971 |
| (18) Guide for Submission of Information on Analytical X-Ray  Equipment Required Pursuant to 21-CFR 1002.10 240 04/30/1974 |
| (19) Guide for Submission of Information on Industrial  Radiofrequency Dielectric Heater and Sealer Equipment Pursuant to 21  CFR 1002.10 and 1002.12 (FDA 81-8137) 254 09/01/1980 |
| (20) Guide for Submission of Information on Industrial X-Ray  Equipment Required Pursuant to 21-CFR 1002.10 237 03/01/1973 |
| (21) Information Requirements for Cookbooks and User and Service  Manuals 697 10/31/1988 |
| (22) Keeping Up With the Microwave Revolution (FDA Pub No. 91-4160)  356 03/01/1990 |
| (23) Laser Light Show Safety—Who's Responsibility (FDA 86-8262)  13 05/01/1986 |
| (24) Laser Products—Conformance with IEC 60825-1, Am.2 and IEC  60601-2-22; Final Guidance for Industry and FDA (Laser Notice 50)  1346 07/26/2001 |
| (25) Letter to All Foreign Manufacturers and Importers of Electronic  Products for Which Applicable FDA Performance Standards Exist 231  05/28/1981 |
| (26) Policy on Maximum Timer Interval and Exposure Schedule for  Sunlamp Products 342 08/21/1986 |
| (27) Quality Control Guide for Sunlamp Products (FDA 88-8234) 270  03/01/1988 |
| (28) Quality Control Practices for Compliance with the Federal  Mercury Vapor Lamp Performance Standard 349 05/01/1980 |
| (29) Reporting and Compliance Guide for Television Products  including Product Report, Supplemental Report, Radiation Safety  Abbreviated Report, Annual Report, Information and Guidance 260  10/01/1995 |
| (30) Reporting Guide for Laser Light Shows and Displays (21-CFR1002)  (FDA 88-8140) 251 09/01/1995 |
| (31) Reporting Guide for Product Reports on High Intensity Mercury  Vapor Discharge Lamps (21 CFR 1002) 348 09/01/1995 |
| (32) Reporting of New Model Numbers to Existing Model Families 675  06/14/1983 |
| (33) Revised Guide for Preparing Annual Reports on Radiation Safety  Testing of Laser and Laser Light Show Products (replaces FDA  82-8127) 264 09/01/1995 |
| (34) Suggested State Regulations for Control of Radiation—Volume  II Nonionizing Radiation—Lasers (FDA Pub No. 83-8220) 70  01/01/1982 |
| (35) Wireless Medical Telemetry Risks and Recommendations 1173  09/27/2000 |
| (36) Assessing User Fees: PMA Supplement Definitions, Modular PMA  Fees, BLA and Efficacy Supplement Definitions, Bundling Multiple  Devices in a Single Application, and Fees for Combination Products;  Guidance for Industry and FDA CBER 1201 02/25/2003 |
| (37) Compliance with Section 301 of the Medical Device User Fee and  Modernization Act of 2002—Identification of Manufacturer of  Medical Devices—Draft Guidance for Industry and FDA Staff CBER  1217 06/23/2003 |
| (38) Draft Guidance for Industry: Drugs, Biologics, and Medical  Devices Derived from Bioengineered Plants for Use in Humans and  Animals CBER   09/06/2002 |
| (39) Guidance for Industry: FDA Export Certificates CBER 1417  07/12/2004 |
| (40) “Help-Seeking” and Other Disease Awareness Communications by or  on behalf of Drug and Device Firms - Draft Guidance for Industry  CBER  CDER  CDRH   02/10/2004 |
| (41) Bundling Multiple Devices or Multiple Indications in a Single  Submission—Guidance for Industry and FDA Staff CBER  CDRH 1215 11/26/2003 |
| (42) Expedited Review of Premarket Submissions for Devices—Guidance for Industry and FDA Staff CBER  CDRH 108 11/26/2003 |
| (43) FY 2005 MDUFMA Small Business Qualification Worksheet and  Certification—Guidance for Industry and FDA CBER  CDRH 2005 08/02/2004 |
| (44) FY 2006 MDUFMA Small Business Qualification Worksheet and  Certification—Guidance for Industry and FDA CBER  CDRH 2006 08/17/2005 |
| (45) Guidance for Industry and FDA Staff—Use of Symbols on Labels  and in Labeling of In Vitro Diagnostic Devices Intended for  Professional Use CBER  CDRH 4444 11/30/2004 |
| (46) Requests for Inspection by an Accredited Person Under the  Inspection by Accredited Persons Program Authorized by Section 201  of the Medical Device User Fee and Modernization Act of 2002—Gudiance for Industry, FDA Staff, and FDA-Accredited Third-Parties  CBER  CDRH 1532 09/15/2005 |
| (47) Resolution of Disputes Concerning Payment or Refund of Medical  Device User Fees Under MDUFMA—Guidance for Industry and FDA Staff  CBER  CDRH 1303 11/17/2004 |
| (48) User Fees and Refunds for Premarket Approval Applications—Guidance for Industry and FDA Staff CBER  CDRH 1224 11/24/2003 |
| (49) User Fees and Refunds for Premarket Notification Submissions  (510(k)s)—Guidance for Industry and FDA Staff CBER  CDRH 1511 05/28/2004 |
| (50) Acceptance of Foreign Clinical Studies; Guidance for Industry  CDER   03/13/2001 |
| (51) Clinical Development Programs for Drugs, Devices, and  Biological Products Intended for the Treatment of Osteoarthritis  CDER 2199 07/07/1999 |
| (52) Draft Guidance for Industry on Providing Regulatory Submissions  in Electronic Format—General Considerations CDER   10/22/2003 |
| (53) Guidance for Industry: Chronic Cutaneous Ulcer and Burn Wounds  Developing Products for Treatment CDER   06/01/2000 |
| (54) Guidance for Industry; Collection of Race and Ethnicity Data in  Clinical Trials CDER   09/01/2005 |
| (55) Part 11, Electronic Records; Electronic Signatures—Scope and  Application CDER   09/05/2003 |
| (56) Implementation of the Inspection by Accredited Persons Program  Under The Medical Device User Fee and Modernization Act of 2002;  Accreditation Criteria: Guidance for Industry, FDA Staff, and Third  Parties CDRH 1200 10/04/2004 |
| (57) Alternative to Certain Prescription Device Labeling  Requirements OC 1150 01/21/2000 |
| (58) Civil Money Penalty Policy OC 1124 06/08/1999 |
| (59) Classification Names for Medical Devices and In Vitro  Diagnostic Products (FDA Pub No. 95-4246) OC 10 03/01/1995 |
| (60) Color Additive Petitions (p. II-19 of PMA Manual) OC 296  06/01/1987 |
| (61) Color Additive Status List (Inspection Operations Manual) OC  268 02/01/1989 |
| (62) Commercial Distribution/Exhibit Letter OC 246 04/10/1992 |
| (63) Compliance With Section 301 of the Medical Device User Fee and  Modernization Act of 2002, as amended—Prominent and Conspicuous  Mark of Manufacturers on Single-Use Devices—Draft Guidance for  Industry and FDA Staff OC 1217 10/11/2005 |
| (64) Consumer-Directed Broadcast Advertising of Restricted Devices  OC 1513 02/10/2004 |
| (65) FDA Guide for Validation of Biological Indicator Incubation  Time OC 283 01/01/1986 |
| (66) General Principles of Software Validation; Final Guidance for  Industry and FDA Staff OC 938 01/11/2002 |
| (67) Guidance on Performance Standard for Lead Wires and Patient  Cables OC 1197 03/09/1998 |
| (68) Guideline for the Monitoring of Clinical Investigations OC 428  01/01/1988 |
| (69) Implementation of the Biomaterials Access Assurance Act of  1998; Draft Guidance for Industry and FDA OC 1324 04/02/2001 |
| (70) Letter to Medical Device Manufacturer on Pentium processors OC  456 02/14/1995 |
| (71) Medical Device Tracking—Guidance for Industry and FDA Staff  OC 169 05/05/2003 |
| (72) Preproduction Quality Assurance Planning: Recommendations for  Medical Device Manufacturers (FDA 90-4236) OC 295 09/01/1989 |
| (73) Sec. 300.600 Commercial Distribution with Regard to Premarket  Notification [Section 510(k)] [CPG 7124.19] OC 181 09/24/1987 |
| (74) Sterilized Convenience Kits for Clinical and Surgical Use;  Final Guidance for Industry OC 1390 01/07/2002 |
| (75) User Labeling for Devices that Contain Natural Rubber (21 CFR  801.437); Small Entity Compliance Guide; Guidance for Industry OC  1212 04/01/2003 |
| (76) Preparing Notices of Availability of Investigational Medical  Devices and for Recruiting Study Subjects OC/DBM 2229 03/19/1999 |
| (77) Regulating In Vitro Diagnostic Device (IVD) Studies OC/DBM 1132  12/17/1999 |
| (78) Guidance on Electrosurgical Devices and the Application of the  Performance Standard for Electrode Lead Wires and Patient Cables  OC/DE1 1129 11/15/1999 |
| (79) Letter to Medical Device Industry on Endoscopy and Laparoscopy  Accessories (Galdi) OC/DE1 545 05/17/1993 |
| (80) All U.S. Condom Manufacturers, Importers and Repackagers OC/DE2  2510 04/07/1987 |
| (81) Condoms: Inspection and Sampling at Domestic Manufacturers and  of all Repackers; Sampling from all Importers (Damaska Memo to Field  on 4/8/87) OC/DE2 293 04/08/1987 |
| (82) Dental Handpiece Sterilization (Dear Doctor Letter) OC/DE2 589  09/28/1992 |
| (83) Draft Guidance for Industry on Surveillance and Detention  Without Physical Examination of Condoms OC/DE2 1139 08/14/2000 |
| (84) Ethylene Oxide; Ethylene Chlorohydrin; and Ethylene Glycol;  Proposed Maximum Residue Limits and Maximum Levels of Exposure  OC/DE2 1019 06/23/1978 |
| (85) Hazards of Volume Ventilators and Heated Humidifiers OC/DE2 901  09/15/1993 |
| (86) Latex Labeling Letter (Johnson) OC/DE2 831 03/18/1993 |
| (87) Letter—Condom Manufacturers and Distributors OC/DE2 56  04/05/1994 |
| (88) Letter—Manufacturers, Distributors and Importers of Condom  Products (included in Condom Packet 398) OC/DE2 52 02/23/1994 |
| (89) Letter—Manufacturers, Importers, and Repackagers of Condoms  for Contraception or Sexually-Transmitted Disease Prevention (Holt)  OC/DE2 53 02/13/1989 |
| (90) Letter to Industry, Powered Wheelchair Manufacturers from  RMJohnson OC/DE2 869 05/10/1993 |
| (91) Letter to Manufacturers/Repackers Using Cotton OC/DE2 101  04/22/1994 |
| (92) Letter to Ophthalmologists about Lasers for Refractive Surgery  OC/DE2 8323 06/27/1997 |
| (93) Manufacturers and Initial Distributors of Hemodialyzers OC/DE2  2507 05/23/1996 |
| (94) Manufacturers and Initial Distributors of Sharps Containers and  Destroyers Used by Health Care Professionals OC/DE2 933 02/03/1994 |
| (95) Pesticide Regulation Notice 94-4 Interim Measures for the  Registration of Antimicrobial Products/Liquid Chemical Germicides  with Medical Device Use Claims OC/DE2 851 06/30/1994 |
| (96) Prospective Manufacturers of Barrier Devices used during Oral  Sex for STD Protection OC/DE2 1394 10/31/1996 |
| (97) Shielded Trocars and Needles Used for Abdominal Access During  Laparoscopy OC/DE2 1122 08/23/1996 |
| (98) Standard Specification for Rubber Contraceptives (Condoms)  OC/DE2 628 10/28/1983 |
| (99) Surveillance and Detention Without Physical Examination of  Surgeons' and/or Patient Examination Gloves; Guidance for Industry—Draft OC/DE2 1141 07/26/2000 |
| (100) Labeling for Male Condoms Made of Natural Rubber Latex—Class  II Special Controls Guidance Document—Draft Guidance for Industry  and FDA Staff OC/DE2/OBGUB 1548 11/14/2005 |
| (101) Computerized Devices/Processes Guidance—Application of the  Medical Device GMP to Computerized Devices and Manufacturing  Processes OC/DE3 247 05/01/1992 |
| (102) Design Control Guidance for Medical Device Manufacturers  OC/DE3 994 03/11/1997 |
| (103) Enforcement Priorities for Single-Use Devices Reprocessed by  Third Parties and Hospitals OC/DE3 1168 08/14/2000 |
| (104) Guidance for Industry: Labeling for Electronic Anti-Theft  Systems OC/DE3 1170 08/15/2000 |
| (105) Keeping Medical Devices Safe from Electromagnetic Interference  OC/DE3 1081 07/01/1995 |
| (106) Labeling Recommendations for Single-Use Devices Reprocessed by  Third Parties and Hospitals; Final Guidance for Industry and FDA  OC/DE3 1392 07/30/2001 |
| (107) Letter to Trade Association: ReUse of Single-use or Disposable  Medical Devices OC/DE3 961 12/27/1995 |
| (108) Medical Device Electromagnetic Interference Issues, Problem  Reports, Standards, and Recommendations OC/DE3 1086 |
| (109) Medical Devices and EMI: The FDA Perspective OC/DE3 1082  01/01/1995 |
| (110) Quality Assurance Guidelines for Hemodialysis Devices OC/DE3  507 02/01/1991 |
| (111) Quality System Information for Certain Premarket Application  Reviews; Guidance for Industry and FDA Staff OC/DE3 1140 02/03/2003 |
| (112) Safety of Electrically Powered Products: Letter To Medical  Device and Electronic Product Manufacturers From Lillian Gill & BHB  correction memo# OC/DE3 1087 09/18/1996 |
| (113) Unsafe Patient Lead Wires and Cables OC/DE3 889 09/03/1993 |
| (114) Draft Guidance: Likelihood of Facilities Inspections When  Modifying Devices Subject to Premarket Approval OC/DPO 1269  08/05/1999 |
| (115) Inspection of Medical Device Manufacturers; Final Guidance for  Industry and FDA OC/DPO/FPB 1702 02/07/2001 |
| (116) Draft Guidance for Industry: Container and Closure Integrity  Testing in Lieu of Sterility Testing as a Component of the Stability  Protocol for Sterile Products OCD   01/28/1998 |
| (117) FDA and Industry Actions on Premarket Approval Applications  (PMAs): Effect on FDA Review Clock and Performance Assessment—Guidance for Industry and FDA Staff OCD 1218 10/08/2003 |
| (118) FDA and Industry Actions on Premarket Notification (510(k))  Submissions: Effect on FDA Review Clock and Performance Assessment—Guidance for Industry and FDA Staff OCD 1219 05/21/2004 |
| (119) Guidance for Industry: Financial Disclosure by Clinical  Investigators OCD   03/20/2001 |
| (120) Premarket Assessment of Pediatric Medical Devices—Guidance  for Industry and FDA Staff OCD 1220 05/14/2004 |
| (121) Resolving Scientific Disputes Concerning the Regulation of  Medical Devices, A Guide to use of the Medical Devices Dispute  Resolution Panel; Final Guidance for Industry and FDA OCD 1121  07/02/2001 |
| (122) FDA Modernization Act of 1997: Guidance for the Device  Industry on Implementation of Highest Priority Provisions;  Availability OCER 434 02/06/1998 |
| (123) CDRH Manual for Good Guidance Practices (GGP) Regulations;  Final Guidance for FDA Staff OCER/DDUPSA 1323 02/09/2001 |
| (124) Do It By Design—An Introduction to Human Factors in Medical  Devices OCER/DDUPSA 995 12/01/1996 |
| (125) Frequently Asked Questions about the Reprocessing and Reuse of  Single Use Devices by Third Party and Hospital Reprocessors; Final  Guidance for Industry and FDA Staff OCER/DDUPSA 1333 07/06/2001 |
| (126) Frequently Asked Questions about the Reprocessing and Reuse of  Single-Use Devices by Third-Party and Hospital Reprocessors; Three  Additional Questions—Guidance for Industry, FDA Staff, Third-Party  and Hospital Reprocessors OCER/DDUPSA 1427 07/16/2003 |
| (127) Frequently-Asked-Questions about the Reprocessing and Reuse of  Single-Use Devices by Third-Party and Hospital Reprocessors: Three  Additional Questions; Final Guidance for Industry and FDA Staff  OCER/DDUPSA 1408 07/09/2002 |
| (128) Guidance on Medical Device Patient Labeling; Final Guidance  for Industry and FDA Reviewers OCER/DDUPSA 1128 04/19/2001 |
| (129) Human Factors Points to Consider for IDE Devices OCER/DDUPSA  839 01/17/1997 |
| (130) Human Factors Principles for Medical Device Labeling  OCER/DDUPSA 227 09/01/1993 |
| (131) Medical Device Reporting for User Facilities OCER/DDUPSA 989  04/01/1996 |
| (132) Medical Device Use-Safety: Incorporating Human Factors  Engineering into Risk Management OCER/DDUPSA 1497 07/18/2000 |
| (133) Accidental Radioactive Contamination of Human Food and Animal  Feeds: Recommendations for State and Local Agencies OCER/DMQRP 1071  08/13/1998 |
| (134) Clarification of Radiation Control Regulations for Diagnostic  X-Ray Equipment (FDA 89-8221) OCER/DMQRP 758 03/01/1989 |
| (135) The Mammography Quality Standards Act Final Regulations  Document 3 OCER/DMQRP 1496 07/18/2000 |
| (136) The Mammography Quality Standards Act Final Regulations  Modifications and Additions to Policy Guidance Help System #11—Guidance for Industry, MQSA Inspectors, and FDA Staff OCER/DMQRP  1569 08/12/2005 |
| (137) The Mammography Quality Standards Act Final Regulations:  Modifications and Additions to Policy Guidance Help System #10—Guidance for Industry and FDA Staff OCER/DMQRP 1554 10/31/2005 |
| (138) The Mammography Quality Standards Act Final Regulations:  Modifications and Additions to Policy Guidance Help System #9—Draft Guidance for Industry and FDA OCER/DMQRP 1539 07/15/2005 |
| (139) Guidance for Industry and FDA Staff—Exemption from Reporting  and Recordkeeping Requirements for Low Power Laser Products (Laser  Notice 54) OCER/DMQRP OCER/DMQRP/EPDB 1592 01/06/2006 |
| (140) A Guide for the Submission of an Abbreviated Radiation Safety  Report on X-Ray Tables, Cradles, Film Changers or Cassette Holders  Intended for Diagnostic Use OCER/DMQRP/DDB 978 03/01/1996 |
| (141) A Guide for the Submission of An Abbreviated Radiation Safety  Reports on Cephalometric Devices Intended for Diagnostic Use  OCER/DMQRP/DDB 977 03/01/1996 |
| (142) A Guide for the Submission of Initial Reports on Diagnostic  X-Ray Systems and their Major Components OCER/DMQRP/DDB 257  01/01/1982 |
| (143) Compliance Program Guidance Manual: Field Compliance Testing  of Diagnostic (Medical) X-ray Equipment OCER/DMQRP/DDB 1133  03/15/2000 |
| (144) Guide for the Submission of Initial Reports on Computed  Tomography X-Ray Systems OCER/DMQRP/DDB 271 12/01/1985 |
| (145) Information Disclosure by Manufacturers to Assemblers for  Diagnostic X-ray Systems; Guidance for Industry and FDA Staff  OCER/DMQRP/DDB 2619 09/05/2003 |
| (146) Manufacturers/Assemblers of Diagnostic X-ray Systems:  Enforcement Policy for Positive-Beam Limitation (PBL) Requirements  in 21 CFR 1020.31(g) OCER/DMQRP/DDB 116 10/13/1993 |
| (147) Abbreviated Reports on Radiation Safety for Microwave Products  (Other Than Microwave Ovens)—E.G. Microwave Heating, Microwave  Diathermy, RF Sealers, Induction, Dielectric Heaters, Security  Systems OCER/DMQRP/EPDB 236 08/01/1995 |
| (148) Applicability of the Performance Standard for High-Intensity  Mercury Vapor Discharge Lamps (21 CFR 1040.30)—Guidance for  Industry and FDA Staff OCER/DMQRP/EPDB 1565 11/06/2005 |
| (149) Application for a Variance from 21 CFR 1040.11(c) for a Laser  Light Show, Display, or Device OCER/DMQRP/EPDB 903 03/01/1987 |
| (150) Compliance Guide for Laser Products (FDA 86-8260)  OCER/DMQRP/EPDB 278 09/01/1985 |
| (151) Exemption from Reporting and Record keeping Requirements for  Certain Sunlamp Product Manufacturers OCER/DMQRP/EPDB 343 09/16/1981 |
| (152) Guide for Establishing and Maintaining a Calibration Constancy  Intercomparison System for Microwave Oven Compliance Survey  Instruments (FDA 88-8264)] OCER/DMQRP/EPDB 286 03/01/1988 |
| (153) Guide for Preparing Product Reports for Lasers and Products  Containing Lasers OCER/DMQRP/EPDB 277 09/01/1995 |
| (154) Guide for the filing of Annual Reports for X-Ray Components  and Systems OCER/DMQRP/EPDB 253 07/01/1980 |
| (155) Imports Radiation-Producing Electronic Products (FDA 89-8008)  OCER/DMQRP/EPDB 756 11/01/1988 |
| (156) Letter to All Manufacturers and Importers of Microwave Ovens:  Retention of Records Required by 21 CFR 1002 OCER/DMQRP/EPDB 880  08/24/1981 |
| (157) Open Door Operation of Microwave Ovens as a Result of Oven  Miswiring OCER/DMQRP/EPDB 646 03/28/1980 |
| (158) Policy on Lamp Compatibility (sunlamps) OCER/DMQRP/EPDB 2343  09/02/1986 |
| (159) Policy on Warning Label Required on Sunlamp Products  OCER/DMQRP/EPDB 1343 06/25/1985 |
| (160) Procedures for Laboratory Compliance Testing of Television  Receivers OCER/DMQRP/EPDB 945 05/01/1986 |
| (161) Responsibilities of Laser Light Show Projector Manufacturers,  Dealers, and Distributors; Final Guidance for Industry and FDA—Laser Notice 51 OCER/DMQRP/EPDB 1349 05/27/2001 |
| (162) Compliance Guidance—The Mammography Quality Standards Act  Final Regulations: Preparing For MQSA Inspections; Final Guidance  for Industry and FDA OCER/DMQRP/ICB 6400 11/05/2001 |
| (163) Guidance for Industry and FDA Staff—Mammography Facility  Surveys, Mammography Equipment Evaluations, and Medical Physicist  Qualification Requirements under MQSA OCER/DMQRP/ICB 6409 09/13/2005 |
| (164) 510(k) Manual—Premarket Notification: 510(k)—Regulatory  Requirements for Medical Devices OCER/DSMICA 469 08/01/1995 |
| (165) Certification Statement for the Impact Resistance Test  OCER/DSMICA 1460 10/25/1993 |
| (166) Comparison Chart: 1996 Quality System Reg vs. 1978 Good  Manufacturing Practices Reg vs. ANSI/ISO/ASQC Q9001 and ISO/DI  13485:1996 OCER/DSMICA 133 |
| (167) DRAFT Guidance for Staff, Industry and U.S./EU CABs;  Implementation Plan for the MRA between the EU and the USA:  Confidence Building Program: Overview, Medical Device Annex, Version  7 June 29, 2000 OCER/DSMICA 1396 |
| (168) DRAFT Guidance for Staff, Industry and U.S./EU CABs;  Implementation Plan for the MRA between the EU and the USA:  Confidence Building Program: Procedures, Medical Device Annex,  Version 7 June 29, 2000 OCER/DSMICA 1397 |
| (169) Draft Medical Glove Guidance Manual OCER/DSMICA 852 07/30/1999 |
| (170) Guidance for Staff, Industry and Third Parties: Third Party  Programs Under the Sectoral Annex on Medical Devices to the  Agreement on Mutual Recognition Between the United States of America  and the European Community (MRA) OCER/DSMICA 1114 01/06/1999 |
| (171) Impact Resistant Lenses: Questions and Answers (FDA 87-4002)  OCER/DSMICA 23 09/01/1987 |
| (172) Implementation of Third Party Programs Under the FDA  Modernization Act of 1997; Final Guidance for Staff, Industry and  Third Parties OCER/DSMICA 1160 02/02/2001 |
| (173) In Vitro Diagnostic Devices: Guidance for the Preparation of  510(k) Submissions OCER/DSMICA 471 01/01/1997 |
| (174) Labeling—Regulatory Requirements for Medical Devices (FDA  89-4203) OCER/DSMICA 470 09/01/1989 |
| (175) Medical Device Appeals and Complaints: A Guidance on Dispute  Resolution OCER/DSMICA 396 02/19/1998 |
| (176) Medical Device Quality Systems Manual: A Small Entity  Compliance Guide OCER/DSMICA 6303 12/01/1996 |
| (177) Medical Device Reporting for Manufacturers OCER/DSMICA 987  03/01/1997 |
| (178) Overview of FDA Modernization Act of 1997, Medical Device  Provisions OCER/DSMICA 1174 02/19/1998 |
| (179) Regulation of Medical Devices: Background Information for  International Officials OCER/DSMICA 610 04/14/1999 |
| (180) #D95-2, Attachment A (Interagency Agreement between FDA & HCFA) ODE 2106 09/15/1995 |
| (181) #D95-2, Attachment B (Criteria for Categorization of  Investigational Devices (HCFA) ODE 3106 09/15/1995 |
| (182) 30-Day Notices and 135-day PMA Supplements for Manufacturing  Method or Process Changes, Guidance for Industry and CDRH (Docket  98D-0080); Final ODE 795 02/19/1998 |
| (183) 510(k) Additional Information Procedures #K93-1 (blue book  memo) ODE 886 07/23/1993 |
| (184) 510(k) Quality Review Program (blue book memo) ODE 344  03/29/1996 |
| (185) 510(k) Refuse to Accept Procedures #K94-1 (blue book memo) ODE  401 05/20/1994 |
| (186) 510(k) Sign-Off Procedures #K94-2 (blue book memo) ODE 308  06/03/1994 |
| (187) A New 510(k) Paradigm—Alternate Approaches to Demonstrating  Substantial Equivalence in Premarket Notifications ODE 905  03/20/1998 |
| (188) A Pilot Program to Evaluate a Proposed Globally Harmonized  Alternative for Premarket Procedures; Guidance for Industry and FDA  Staff ODE 1347 11/10/2005 |
| (189) A Suggested Approach to Resolving Least Burdensome Issues ODE  1188 09/11/2000 |
| (190) Application of the Device Good Manufacturing Practice (GMP)  Regulation to the Manufacture of Sterile Devices ODE 267 12/01/1983 |
| (191) Assignment of Review Documents #I90-2 (blue book memo) ODE 366  08/24/1990 |
| (192) Availability of Information Given to Advisory Committee  Members in Connection with CDRH Open Public Panel Meetings; Draft  Guidance for Industry and FDA Staff ODE 1341 07/18/2001 |
| (193) Center for Devices and Radiological Health's Investigational  Device Exemption (IDE) Refuse to Accept Policy ODE 4859 06/30/1993 |
| (194) Center for Devices and Radiological Health's Premarket  Notification [510(k)] Refuse to Accept Policy—(updated Checklist  3/14/1995) ODE 3859 06/30/1993 |
| (195) Changes or Modifications During the Conduct of a Clinical  Investigation; Final Guidance for Industry and CDRH Staff ODE 1337  05/29/2001 |
| (196) Classified Convenience Kits ODE 789 04/30/1993 |
| (197) Consolidated Review of Submissions for Diagnostic Ultrasound  Equipment, Accessories and Related Measurement Devices #G90-2 (blue  book memo) ODE 30 10/19/1990 |
| (198) Consolidated Review of Submissions for Lasers and Accessories  #G90-1 (blue book memo) ODE 31 10/19/1990 |
| (199) Continued Access to Investigational Devices During PMA  Preparation and Review (Blue Book Memo) (D96-1) ODE 872 07/15/1996 |
| (200) Convenience Kits Interim Regulatory Guidance ODE 562  05/20/1997 |
| (201) Cover Letter: 510(k) Requirements During Firm-Initiated  Recalls; Attachment A: Guidance on Recall and Premarket Notification  Review Procedures During Firm-Initiated Recalls of Legally Marketed  Devices (blue book memo #K95-1) ODE 406 11/21/1995 |
| (202) Deciding When to Submit a 510(k) for a Change to an Existing  Device (K97-1) ODE 935 01/10/1997 |
| (203) Deciding When To Submit a 510(k) for a Change to an Existing  Wireless Telemetry Medical Device; Final Guidance for FDA Reviewers  and Industry ODE 1073 11/30/2000 |
| (204) Determination of Intended Use for 510(k) Devices; Guidance for  CDRH Staff ODE 857 12/03/2002 |
| (205) Device Labeling Guidance #G91-1 (blue book memo) ODE 414  03/08/1991 |
| (206) Distribution and Public Availability of PMA Summary of Safety  and Effectiveness Data Packages ODE 563 10/10/1997 |
| (207) Document Review Processing #I91-1 (blue book memo) ODE 446  02/12/1992 |
| (208) Documentation and Resolution of Differences of Opinion on  Product Evaluations #G93-1 (blue book memo) ODE 920 12/23/1993 |
| (209) Early Collaboration Meetings Under the FDA Modernization Act  (FDAMA); Final Guidance for Industry and for CDRH Staff ODE 310  02/28/2001 |
| (210) Format for IDE Progress Reports ODE 311 06/01/1996 |
| (211) Frequently Asked Questions on the New 510(k) Paradigm; Final  ODE 2230 10/22/1998 |
| (212) Goals and Initiatives for the IDE Program #D95-1 (blue book  memo) ODE 405 07/12/1995 |
| (213) Guidance for Industry; General/Specific Intended Use; Final  ODE 499 11/04/1998 |
| (214) Guidance for Off-the-Shelf Software Use in Medical Devices;  Final ODE 585 09/09/1999 |
| (215) Guidance for Submitting Reclassification Petition ODE 609  01/01/1997 |
| (216) Guidance on Amended Procedures for Advisory Panel Meetings;  Final ODE 413 07/22/2000 |
| (217) Guidance on IDE Policies and Procedures; Final ODE 882  01/20/1998 |
| (218) Guidance on PMA Interactive Procedures for Day-100 Meetings  and Subsequent Deficiencies—for Use by CDRH and Industry; Final  ODE 322 02/19/1998 |
| (219) Guidance on Section 216 of the Food and Drug Administration  Modernization Act of 1997 ODE 1135 08/09/2000 |
| (220) Guidance on the Center for Devices and Radiological Health's  Premarket Notification Review Program #K86-3 (blue book memo) ODE  289 06/30/1986 |
| (221) Guidance on the Use of Standards in Substantial Equivalence  Determinations; Final ODE 1131 03/12/2000 |
| (222) Guidance to Industry Supplements to Approved Applications for  Class III Medical Devices: Use of Published Literature, Use of  Previously Submitted Materials, and Priority Review; Final ODE 380  05/20/1998 |
| (223) Guideline on General Principles of Process Validation ODE 425  05/01/1987 |
| (224) Guideline on Validation of the Limulus Amebocyte Lysate (LAL)  Test as an End-Product Endotoxin Test ODE 427 12/01/1987 |
| (225) HCFA Reimbursement Categorization Determinations for  FDA-approved IDEs ODE 4106 09/15/1995 |
| (226) Humanitarian Device Exemptions (HDE) Regulation: Questions and  Answers; Final Guidance for Industry ODE 1381 07/12/2001 |
| (227) IDE Refuse to Accept Procedures #D94-1 (blue book memo) ODE  410 05/20/1994 |
| (228) Implementation of the FDA/HCFA Interagency Agreement Regarding  Reimbursement Categorization of Investigational Devices, Att. A  Interagency Agreement, Att. B Criteria for Catergorization of  Investigational Devices, & Att. C -List #D95-2 (blue book memo) ODE  106 09/15/1995 |
| (229) Indications for Use Statement ODE 879 01/02/1996 |
| (230) Industry Representatives on Scientific Panel ODE 329  03/27/1987 |
| (231) Integrity of Data and Information Submitted to ODE #I91-2  (blue book memo) ODE 447 05/29/1991 |
| (232) Kit Certification for 510(k)s ODE 562 07/01/1997 |
| (233) Labeling Reusable Medical Devices for Reprocessing in Health  Care Facilities: FDA Reviewer Guidance ODE 198 04/01/1996 |
| (234) Letter to Industry, Powered Wheelchair/Scooter or  Accessory/Component Manufacturer from Susan Alpert, Ph.D.,M.D. ODE  883 05/26/1994 |
| (235) Limulus Amebocute Lysate; Reduction of Samples for Testing ODE  178 10/23/1987 |
| (236) Master Files Part III; Guidance on Scientific and Technical  Information ODE 338 06/01/1987 |
| (237) Medical Devices Containing Materials Derived from Animal  Sources (Except In Vitro Diagnostic Devices), Guidance for FDA  Reviewers and Industry; Final ODE 2206 11/16/1998 |
| (238) Meetings with the Regulated Industry #I89-3 (blue book Memo)  ODE 367 11/20/1989 |
| (239) Memorandum of Understanding Regarding Patient Labeling Review  (Blue Book Memo #G96-3) ODE 806 08/09/1996 |
| (240) Memorandum: Electromagnetic Compatibility for Medical Devices:  Issues and Solutions ODE 639 06/13/1995 |
| (241) Methods for Conducting Recall Effectiveness Checks ODE 225  06/16/1978 |
| (242) New section 513(f)(2)—Evaluation of Automatic Class III  Designation: Guidance for Industry and CDRH Staff; Final ODE 199  02/19/1998 |
| (243) Nondisclosure of Financially Sensitive Information #I92-1  (blue book memo) ODE 587 03/05/1992 |
| (244) ODE Executive Secretary Guidance Manual G87-3 ODE 1338  08/07/1987 |
| (245) Panel Report and Recommendations on PMA Approvals #P86-5 (blue  book memo) ODE 306 04/18/1986 |
| (246) Panel Review of Premarket Approval Applications #P91-2 (blue  book memo) ODE 444 05/03/1991 |
| (247) Pediatric Expertise for Advisory Panels; Guidance for Industry  and FDA Staff ODE 1208 06/03/2003 |
| (248) PMA Compliance Program #P91-3 (blue book memo) ODE 445  05/03/1991 |
| (249) Points to Consider in the Characterization of Cell Lines Used  to Produce Biological Products ODE 269 06/01/1984 |
| (250) Policy Development and Review Procedures #I90-1 (blue book  memo) ODE 368 02/15/1990 |
| (251) Preamendment Class III Devices ODE 584 03/11/1992 |
| (252) Preamendments Class III Strategy ODE 611 04/19/1994 |
| (253) Premarket Approval Application (PMA) Closure #P94-2 (blue book  memo) ODE 403 07/08/1994 |
| (254) Premarket Approval Application Modular Review—Guidance for  Industry and FDA Staff ODE 835 11/03/2003 |
| (255) Premarket Notification—Consistency of Reviews #K89-1 (blue  Book memo) ODE 339 02/28/1989 |
| (256) Premarket Notification [510(k)] Status Request Form ODE 858  03/07/1994 |
| (257) Procedures for Class II Device Exemptions from Premarket  Notification Guidance for Industry and CDRH Staff; Final ODE 159  02/19/1998 |
| (258) Questions and Answers for the FDA Reviewer Guidance: Labeling  Reusable Medical Devices for Reprocessing in Health Care Facilities  ODE 1198 09/03/1996 |
| (259) Real-Time Review Program for Premarket Approval Application  (PMA) Supplements ODE 673 04/22/1997 |
| (260) Review of IDEs for Feasibility Studies #D89-1 (blue book memo)  ODE 362 05/17/1989 |
| (261) Review of Laser Submissions #G88-1 (blue book memo) ODE 330  04/15/1988 |
| (262) Shelf Life of Medical Devices ODE 415 04/01/1991 |
| (263) SMDA Changes—Premarket Notification; Regulatory Requirements  for Medical Devices (510k) Manual Insert ODE 655 04/17/1992 |
| (264) Substantial Equivalence (SE) Decision Making Documentation  ATTACHED: 'SE' Decision Making Process (Detailed) i.e. the decision  making tree ODE 390 01/01/1990 |
| (265) Suggested Content for Original IDE Application Cover Letter  ODE 797 02/27/1996 |
| (266) Suggested Format for Developing and Responding to Deficiencies  in Accordance with the Least Burdensome Provisions of FDAMA ODE 1195  11/02/2000 |
| (267) Telephone Communications Between ODE Staff and Manufacturers  #I93-1 (blue book memo) ODE 360 01/29/1993 |
| (268) The Least Burdensome Provisions of the FDA Modernization Act  of 1997: Concept and Principles: Final Guidance for FDA and Industry  ODE 1332 10/04/2002 |
| (269) Threshold Assessment of the Impact of Requirements for  Submission of PMAs for 31 Medical Devices Marketed Prior to May 28,  1976 ODE 352 01/01/1990 |
| (270) Toxicology Risk Assessment Committee #G89-1 (blue book memo)  ODE 363 08/09/1989 |
| (271) Updated 510(k) Sterility Review Guidance K90-1; Final Guidance  for Industry and FDA ODE 361 08/30/2002 |
| (272) Use of International Standard ISO-10993, 'Biological  Evaluation of Medical Devices Part 1: Evaluation and Testing'  (Replaces #G87-1 #8294) (blue book memo) ODE 164 05/01/1995 |
| (273) Draft Guidance for Industry and FDA Staff—Functional  Indications for Implantable Cardioverter Defibrillators ODE OC 1304 10/06/2005 |
| (274) Guidance for Industry—Cybersecurity for Networked Medical  Devices Containing Off-the-Shelf (OTS) Software ODE OC 1553 01/14/2005 |
| (275) Addendum to: Guidance on Premarket Notification [510(k)]  Submissions for Sterilizers Intended for Use in Health Care  Facilities ODE/DAGID 1833 09/19/1995 |
| (276) Class II Special Controls Guidance Document: Apnea Monitors;  Guidance for Industry and FDA ODE/DAGID 1178 07/17/2002 |
| (277) Class II Special Controls Guidance Document: Optical  Impression Systems for Computer Assisted Design and Manufacturing  (CAD/CAM) of Dental Restorations; Guidance for Industry and FDA  ODE/DAGID 1203 04/22/2003 |
| (278) Dental Cements—Premarket Notification; Final ODE/DAGID 2204  08/18/1998 |
| (279) Dental Impression Materials—Premarket Notification; Final  ODE/DAGID 2203 08/17/1998 |
| (280) Guidance for Industry and FDA Staff: Medical Device User Fee  and Modernization Act of 2002, Validation Data in Premarket  Notification Submissions (510(k)s) for Reprocessed Single-Use  Medical Devices ODE/DAGID 1216 06/01/2004 |
| (281) Guidance on Premarket Notification 510(k) for Sterilizers  Intended for Use in Health Care Facilities ODE/DAGID 833 03/01/1993 |
| (282) Guidance on the Content of Premarket Notification [510(k)]  Submissions for Protective Restraints ODE/DAGID 993 12/01/1995 |
| (283) OTC Denture Cushions, Pads, Reliners, Repair Kits, and  Partially Fabricated Denture Kits; Final ODE/DAGID 2205 08/17/1998 |
| (284) Reprocessing and Reuse of Single-Use Devices: Review  Prioritization Scheme; Draft ODE/DAGID 1156 02/08/2000 |
| (285) Class II Special Control Guidance Document for Acute Upper  Airway Obstruction Devices; Final ODE/DAGID/ARDB 1138 07/03/2000 |
| (286) Class II Special Controls Guidance Document: Cutaneous Carbon  Dioxide (PcCo2) and Oxygen (PcO2) Monitors; Guidance for Industry  and FDA ODE/DAGID/ARDB 1335 12/13/2002 |
| (287) Class II Special Controls Guidance Document: Indwelling Blood  Gas Analyzers; Final Guidance for Industry and FDA ODE/DAGID/ARDB  1126 10/05/2001 |
| (288) Draft 510(K) Submission Requirements for Peak Flow Meters  ODE/DAGID/ARDB 999 01/13/1994 |
| (289) Draft Emergency Resuscitator Guidance ODE/DAGID/ARDB 985  04/14/1993 |
| (290) Draft Reviewer Guidance for Ventilators ODE/DAGID/ARDB 500  07/01/1995 |
| (291) Draft Reviewer Guidance on Face Masks and Shield for CPR  ODE/DAGID/ARDB 996 03/16/1994 |
| (292) Excerpts Related to EMI from November 1993 Anesthesiology and  Respiratory Devices Branch (includes EMI standard) ODE/DAGID/ARDB  638 11/01/1993 |
| (293) General Guidance Document: Non-Invasive Pulse Oximeter  ODE/DAGID/ARDB 997 09/07/1992 |
| (294) Guidance Document for Premarket Notification Submissions for  Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen  Dioxide Analyzer; Final ODE/DAGID/ARDB 1157 01/24/2000 |
| (295) Guidance for Oxygen Conserving Device 510(k) Review 73 BZD  868.5905 Non-continuous Ventilator Class II ODE/DAGID/ARDB 583  02/01/1989 |
| (296) Guidance for Peak Flow Meters for Over-the-Counter Sale  ODE/DAGID/ARDB 998 06/23/1992 |
| (297) Heated Humidifier Review Guidance ODE/DAGID/ARDB 780  08/30/1991 |
| (298) Review Guidance for Oxygen Generators and Oxygen Equipment  ODE/DAGID/ARDB 986 |
| (299) Reviewer Guidance for Nebulizers, Metered Dose Inhalers,  Spacers and Actuators ODE/DAGID/ARDB 784 10/01/1993 |
| (300) Class II Special Controls Guidance Document: Dental Sonography  and Jaw Tracking Devices—Guidance for Industry and FDA Staff  ODE/DAGID/DEDB 1393 12/02/2003 |
| (301) Class II Special Controls Guidance Document: Intraoral Devices  for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry  and FDA ODE/DAGID/DEDB 1378 11/12/2002 |
| (302) Class II Special Controls Guidance Document: Root-form  Endosseous Dental Implants and Endosseous Dental Abutments—Guidance for Industry and FDA Staff ODE/DAGID/DEDB 1389 05/12/2004 |
| (303) Dental Bone Grafting Material Devices—Class II Special  Controls Guidance Document—Guidance for Industry and FDA Staff  ODE/DAGID/DEDB 1512 04/28/2005 |
| (304) Dental Composite Resin Devices—Premarket Notification  [510(k)] Submissions—Guidance for Industry and FDA Staff  ODE/DAGID/DEDB 642 10/26/2005 |
| (305) Guidance Document on Dental Handpieces ODE/DAGID/DEDB 556  07/01/1995 |
| (306) Guidance for Industry and FDA Staff—Class II Special  Controls Document: Oral Rinse to Reduce the Adhesion of Dental  Plaque ODE/DAGID/DEDB 1559 09/20/2005 |
| (307) Guidance for Industry and FDA Staff; Class II Special Controls  Guidance Document: Dental Base Metal Alloys ODE/DAGID/DEDB 1416  08/23/2004 |
| (308) Guidance for Industry and FDA Staff; Class II Special Controls  Guidance Document: Dental Noble Metal Alloys ODE/DAGID/DEDB 1415  08/23/2004 |
| (309) Special Control Guidance Document on Encapsulated Amalgam,  Amalgam Alloy, and Dental Mercury Labeling; Draft Guidance for  Industry and FDA ODE/DAGID/DEDB 1192 02/20/2002 |
| (310) Class II Special Controls Guidance document: Implantable  Radiofrequency Transponder System for Patient Identification and  Health Information—Guidance for Industry and FDA Staff  ODE/DAGID/GHDB 1541 12/10/2004 |
| (311) Class II Special Controls Guidance Document: Pharmacy  Compounding Systems; Final Guidance for Industry and FDA  ODE/DAGID/GHDB 1326 03/12/2001 |
| (312) Guidance for Industry and FDA Review Staff—Intravascular  Administration Sets Premarket Notification Submissions [510(k)]  ODE/DAGID/GHDB 1189 04/15/2005 |
| (313) Guidance on 510(k) Submissions for Implanted Infusion Ports  ODE/DAGID/GHDB 392 10/01/1990 |
| (314) Guidance on Premarket Notification [510(K)] Submissions for  Short-Term and Long-Term Intravascular Catheters ODE/DAGID/GHDB 824  03/16/1995 |
| (315) Guidance on the Content of Premarket Notification [510(K)]  Submissions for Clinical Electronic Thermometers ODE/DAGID/GHDB 822  03/01/1993 |
| (316) Guidance on the Content of Premarket Notification [510(k)]  Submissions for External Infusion Pumps ODE/DAGID/GHDB 823  03/01/1993 |
| (317) Guidance on the Content of Premarket Notification [510(K)]  Submissions for Hypodermic Single Lumen Needles ODE/DAGID/GHDB 450  04/01/1993 |
| (318) Guidance on the Content of Premarket Notification [510(K)]  Submissions for Piston Syringes ODE/DAGID/GHDB 821 04/01/1993 |
| (319) Medical Devices with Sharps Injury Prevention Features—Guidance for Industry and FDA Staff ODE/DAGID/GHDB 934 08/09/2005 |
| (320) Neonatal and Neonatal Transport Incubators—Premarket  Notifications; Final ODE/DAGID/GHDB 2201 09/18/1998 |
| (321) CDRH Regulatory Guidance for Washers and Washer-Disinfectors  Intended for use in Processing Reusable Medical Devices  ODE/DAGID/INCB 4 06/02/1998 |
| (322) Class II Special Controls Guidance Document: Medical Washers  and Medical Washer-Disinfectors; Guidance for the Medical Device  Industry and FDA Review Staff ODE/DAGID/INCB 1252 02/07/2002 |
| (323) Guidance on Premarket Notification [510(k)] Submissions for  Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors  Intended for Use in Health Care Facilities ODE/DAGID/INCB 881  08/01/1993 |
| (324) Guidance on Premarket Notification [510(k)] Submissions for  Surgical Gowns and Surgical Drapes ODE/DAGID/INCB 888 08/01/1993 |
| (325) Guidance on the Content and Format of Premarket Notification  [510(k)] Submissions for Liquid Chemical Sterilants and High Level  Disinfectants; Final ODE/DAGID/INCB 397 01/03/2000 |
| (326) Guidance on the Content and Format of Premarket Notification  [510(k)] Submissions for Sharps Containers ODE/DAGID/INCB 895  10/01/1993 |
| (327) Premarket Approval Applications (PMA) for Absorbable Powder  for Lubricating a Surgeon's Glove—Guidance for Industry and FDA  Staff ODE/DAGID/INCB 1230 04/13/2004 |
| (328) Premarket Approval Applications (PMA) for Sharps Needle  Destruction Devices; Final Guidance for Industry and FDA  ODE/DAGID/INCB 891 03/02/2001 |
| (329) Premarket Notification [510(k)] Submissions for Medical  Sterilization Packaging Systems in Health Care Facilities; Draft  Guidance for Industry and FDA ODE/DAGID/INCB 1388 03/07/2002 |
| (330) Premarket Notification [510(k)] Submissions for Testing for  Skin Sensitization to Chemicals in Natural Rubber Products; Final  ODE/DAGID/INCB 944 01/13/1999 |
| (331) Premarket Notifications [510(k)] for Biological Indicators  Intended to Monitor Sterilizers Used in Health Care Facilities;  Draft Guidance for Industry and FDA Reviewers ODE/DAGID/INCB    05/21/2001 |
| (332) Regulatory Status of Disinfectants Used to Process Dialysate  Delivery Systems and Water Purification Systems for Hemodialysis;  Guidance for Industry and FDA ODE/DAGID/INCB 1419 08/30/2002 |
| (333) Surgical Masks—Premarket Notification [510(k)] Submissions;  Guidance for Industry and FDA ODE/DAGID/INCB 94 03/05/2004 |
| (334) Testing for Sensitizing Chemicals in Natural Rubber Latex  Medical Devices (Addendum to 944) ODE/DAGID/INCB 1944 07/28/1997 |
| (335) Balloon Valvuloplasty Guidance For The Submission Of an IDE  Application and a PMA Application ODE/DCD 370 01/01/1989 |
| (336) Battery Guidance ODE/DCD 873 01/01/1994 |
| (337) Policy for Expiration Dating (DCRND RB92-G) ODE/DCD 137  10/30/1992 |
| (338) Cardiac Ablation Catheters Generic Arrhythmia Indications for  Use; Guidance for Industry ODE/DCD/CEMB 1382 07/01/2002 |
| (339) Class II Special Controls Guidance Document: Arrhythmia  Detector and Alarm ODE/DCD/CEMB 1363 10/28/2003 |
| (340) Clinical Study Designs for Percutaneous Catheter Ablation for  Treatment of Atrial Fibrillation—Guidance for Industry and FDA  Staff ODE/DCD/CEMB 1229 01/09/2004 |
| (341) Coronary and Peripheral Arterial Diagnostic Catheters—Guidance for Industry and FDA Staff ODE/DCD/CEMB 1228 07/15/2003 |
| (342) Electrocardiograph (ECG) Electrode ODE/DCD/CEMB 25 02/11/1997 |
| (343) Electrocardiograph (ECG) Lead Switching Adapter ODE/DCD/CEMB  26 02/11/1997 |
| (344) Electrocardiograph (ECG) Surface Electrode Tester ODE/DCD/CEMB  27 02/11/1997 |
| (345) Investigational Device Exemption (IDE) Study Enrollment for  Cardiac Ablation of Typical Atrial Flutter; Final Guidance for  Industry and FDA Reviewers ODE/DCD/CEMB 1199 11/08/2000 |
| (346) Non-Automated Sphygmomanometer (Blood Pressure Cuff) Guidance  Version 1; Final ODE/DCD/CEMB 2239 11/19/1998 |
| (347) Non-Invasive Blood Pressure (NIBP) Monitor Guidance  ODE/DCD/CEMB 123 03/10/1997 |
| (348) Recommended Clinical Study Design for Ventricular Tachycardia  Ablation ODE/DCD/CEMB 2244 05/07/1999 |
| (349) Guidance for Annuloplasty Rings 510(k) Submissions; Final  Guidance for Industry and FDA Staff ODE/DCD/CSPB 1358 01/31/2001 |
| (350) Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter  510(k) Submissions; Final Guidance for Industry and FDA ODE/DCD/CSPB  1622 11/29/2000 |
| (351) Guidance for Cardiopulmonary Bypass Oxygenators 510(k)  Submissions; Final Guidance for Industry and FDA Staff ODE/DCD/CSPB  1361 11/13/2000 |
| (352) Guidance for Extracorporeal Blood Circuit Defoamer 510(k)  Submissions; Final Guidance for Industry and FDA ODE/DCD/CSPB 1632  11/29/2000 |
| (353) Coronary and Cerebrovascular Guidewire Guidance ODE/DCD/ICDB  964 01/01/1995 |
| (354) 1-Consolidated Annual Report for a Device Product Line  (1-CARD); Pilot for Preparation of Annual Reports for Pacemaker  Premarket Approval Applications ODE/DCD/PDLB 1167 07/06/2000 |
| (355) Cardiac Monitor Guidance (including Cardiotachometer and Rate  Alarm); Final ODE/DCD/PDLB 2233 11/05/1998 |
| (356) Diagnostic ECG Guidance (Including Non-Alarming ST Segment  Measurement); Final ODE/DCD/PDLB 2232 11/05/1998 |
| (357) Guidance for the Submission of Research and Marketing  Applications for Permanent Pacemaker Leads and for Pacemaker Lead  Adaptor 510(k) Submissions ODE/DCD/PDLB 372 11/01/2000 |
| (358) Implantable Pacemaker Testing Guidance ODE/DCD/PDLB 383  01/12/1990 |
| (359) Carotid Stent—Suggestions for Content of Submissions to the  Food and Drug Administration in Support of Investigational Devices  Exemption (IDE) Applications ODE/DCD/PVDB 974 10/26/1996 |
| (360) Guidance Document for Vascular Prostheses 510(k) Submissions  ODE/DCD/PVDB 1357 11/01/2000 |
| (361) Guidance for Cardiovascular Intravascular Filter 510(k)  Submissions; Final ODE/DCD/PVDB 24 11/26/1999 |
| (362) Implantable Intra-Aneurysm Pressure Measurement System—Class  II Special Controls Guidance Document ODE/DCD/PVDB 1589 02/15/2006 |
| (363) Non-Clinical Tests and Recommended Labeling for Intravascular  Stents and Associated Delivery Systems—Guidance for Industry and  FDA Staff ODE/DCD/PVDB ODE/DCD/ICDB 1545 01/13/2005 |
| (364) Guidance Document for Powered Suction Pump 510(k)s  ODE/DGRND/GSDB 2207 09/30/1998 |
| (365) Guidance Document for Surgical Lamp 510(k)s; Final  ODE/DGRND/GSDB 1244 07/13/1998 |
| (366) Guidance Document for the Preparation of Premarket  Notification [510(k)] Applications for Electromyograph Needle  Electrodes ODE/DGRND/GSDB 325 07/26/1995 |
| (367) Guidance for the Preparation of a Premarket Notification for  Extended Laparoscopy Devices ODE/DGRND/GSDB 667 08/30/1994 |
| (368) Guidance on the Content and Organization of a Premarket  Notification for a Medical Laser ODE/DGRND/GSDB 386 06/01/1995 |
| (369) Guidelines for Reviewing Premarket Notifications that Claim  Substantial Equivalence to Evoked Response Stimulators  ODE/DGRND/GSDB 593 02/01/1997 |
| (370) Premarket Notificaton [510(k)] Submissions for Chemical  Indicators—Guidance for Industry and FDA Staff ODE/DGRND/INCB 1420  12/19/2003 |
| (371) 510(k) Information Needed for Hydroxyapatite Coated Orthopedic  Implants ODE/DGRND/ORDB 47 02/20/1997 |
| (372) Class II Special Controls Guidance Document: Hip Joint  Metal/Polymer Constrained Cemented or Uncemented Prosthesis  ODE/DGRND/ORDB 1328 04/30/2002 |
| (373) Class II Special Controls Guidance Document: Knee Joint  Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated  Uncemented Prostheses; Guidance for Industry and FDA ODE/DGRND/ORDB  1418 01/16/2003 |
| (374) Class II Special Controls Guidance Document:  Polymethylmethacrylate (PMMA) Bone Cement; Guidance for Industry and  FDA ODE/DGRND/ORDB 668 07/17/2002 |
| (375) Class II Special Controls Guidance: Shoulder Joint  Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated  Uncemented Prosthesis ODE/DGRND/ORDB 1193 10/31/2000 |
| (376) Clinical Data Presentations for Orthopedic Device Applications—Guidance for Industry and FDA Staff ODE/DGRND/ORDB 1542 12/02/2004 |
| (377) Draft Guidance for Industry and FDA Staff—Class II Special  Controls Guidance Document: Intervertebral Body Fusion Device  ODE/DGRND/ORDB 1540 02/09/2006 |
| (378) Guidance Document for Testing Biodegradable Polymer Implant  Devices ODE/DGRND/ORDB 914 04/20/1996 |
| (379) Guidance Document For Testing Bone Anchor Devices  ODE/DGRND/ORDB 915 04/20/1996 |
| (380) Guidance Document for Testing Non-Articulating, 'Mechanically  Locked', Modular Implant Components ODE/DGRND/ORDB 916 05/01/1995 |
| (381) Guidance Document for Testing Orthopedic Implants with  Modified Metallic Surfaces Apposing Bone Or Bone Cement  ODE/DGRND/ORDB 827 04/28/1994 |
| (382) Guidance Document for the Preparation of IDE and PMA  Applications for Intra-Articular Prothetic Knee Ligament Devices  ODE/DGRND/ORDB 233 02/18/1993 |
| (383) Guidance Document for the Preparation of IDEs for Spinal  Systems ODE/DGRND/ORDB 2250 01/13/2000 |
| (384) Guidance Document For The Preparation of Premarket  Notification For Ceramic Ball Hip Systems ODE/DGRND/ORDB 355  01/10/1995 |
| (385) ORDB 510(k) Sterility Review Guidance ODE/DGRND/ORDB 659  07/03/1997 |
| (386) Reviewers Guidance Checklist for Intramedullary Rods  ODE/DGRND/ORDB 956 02/21/1997 |
| (387) Reviewers Guidance Checklist for Orthopedic External Fixation  Devices ODE/DGRND/ORDB 829 02/21/1997 |
| (388) Spinal System 510(k)s—Guidance for Industry and FDA Staff  ODE/DGRND/ORDB 636 05/03/2004 |
| (389) Class II Special Controls Guidance Document: Human Dura Mater;  Guidance for Industry and FDA Staff ODE/DGRND/PRSB 54 12/18/2003 |
| (390) Class II Special Controls Guidance Document: Surgical Sutures;  Guidance for Industry and FDA ODE/DGRND/PRSB 1387 06/03/2003 |
| (391) Cyanoacrylate Tissue Adhesive for the Topical Approximation of  Skin—Premarket Approval Applications (PMAs)—Guidance for  Industry and FDA Staff ODE/DGRND/PRSB 1233 02/13/2004 |
| (392) Guidance Document for Dura Substitute Devices; Final Guidance  for Industry ODE/DGRND/PRSB 1152 11/09/2000 |
| (393) Guidance for Content of Premarket Notifications for Esophageal  and Tracheal Prostheses; Final ODE/DGRND/PRSB 6 04/28/1998 |
| (394) Guidance for Dermabrasion Devices; Final ODE/DGRND/PRSB 2248  03/02/1999 |
| (395) Guidance for Resorbable Adhesion Barrier Devices for Use in  Abdominal and/or Pelvic Surgery; Guidance for Industry  ODE/DGRND/PRSB 1356 06/18/2002 |
| (396) Guidance for Saline, Silicone Gel, and Alternative Breast  Implants; Guidance for Industry and FDA ODE/DGRND/PRSB 1354  02/11/2003 |
| (397) Guidance for Testing MR Interaction with Aneurysm Clips  ODE/DGRND/PRSB 958 05/22/1996 |
| (398) Guidance for the Preparation of a Premarket Notification  Application for a Surgical Mesh; Final ODE/DGRND/PRSB 2247  03/02/1999 |
| (399) Low Energy Ultrasound Wound Cleaner: Class II Special Controls  Guidance Document—Guidance for Industry and FDA Staff  ODE/DGRND/PRSB 1302 11/07/2005 |
| (400) Saline, Silicone Gel, and Alternative Breast Implants—Draft  Guidance for Industry and FDA Staff ODE/DGRND/PRSB 1239 01/13/2004 |
| (401) Class II Special Controls Guidance Document: Resorbable  Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA  ODE/DGRND/REDB 855 06/02/2003 |
| (402) Guidance Document for Powered Muscle Stimulator 510(k)s; Final  ODE/DGRND/REDB 2246 06/09/1999 |
| (403) Guidance Document for the Preparation of Notification (510(k))  Applications for Therapeutic Massagers and Vibrators ODE/DGRND/REDB  818 07/26/1995 |
| (404) Guidance Document for the Preparation of Premarket  Notification [510(k)] Applications for Communications Systems  (Powered and Non-Powered) and Powered Environmental Control Systems  ODE/DGRND/REDB 762 07/26/1995 |
| (405) Guidance Document for the Preparation of Premarket  Notification [510(k)] Applications for Exercise Equipment  ODE/DGRND/REDB 326 07/26/1995 |
| (406) Guidance Document for the Preparation of Premarket  Notification [510(k)] Applications for Heating and Cooling Devices  ODE/DGRND/REDB 828 07/26/1995 |
| (407) Guidance Document for the Preparation of Premarket  Notification [510(k)] Applications for Immersion Hydrobaths  ODE/DGRND/REDB 729 07/26/1995 |
| (408) Guidance Document for the Preparation of Premarket  Notification [510(k)] Applications for Powered Tables and  Multifunctional Physical Therapy Tables ODE/DGRND/REDB 735  07/26/1995 |
| (409) Guidance Document for the Preparation of Premarket  Notification [510(k)] Applications for Submerged (Underwater)  Exercise Equipment ODE/DGRND/REDB 307 07/26/1995 |
| (410) Guidance Document for the Preparation of Premarket  Notification [510k)] Applications for Mechanical and Powered  Wheelchairs, and Motorized Three-Wheeled Vehicles ODE/DGRND/REDB 346  07/26/1995 |
| (411) Guidance for Studies for Pain Therapy Devices - General  Consideration in the Design of Clinical Studies for Pain-Alleviating  Devices ODE/DGRND/REDB 640 05/12/1988 |
| (412) Clinical Trial Considerations: Vertebral Augmentation Devices  to Treat Spinal Insufficiency Fractures—Guidance for Industry and  FDA Staff ODE/DGRND/REDB ODE/DGRND/ORDB 1543 10/24/2004 |
| (413) Guidance for Industry; Noise Claims in Hearing Aid Labeling;  Final ODE/DOED 2210 10/21/1998 |
| (414) Checklist of Information Usually Submitted in an  Investigational Device Exemptions (IDE) Application for Refractive  Surgery Lasers [excimer] ODE/DOED/DSDB 2093 10/10/1996 |
| (415) Discussion Points for Expansion of the 'Checklist of  Information Usually Submitted in an Investigational Device Exemption  (IDE) Application for Refractive Surgery Lasers' Draft Document  ODE/DOED/DSDB 7093 09/05/1997 |
| (416) Guidance Document for Nonprescription Sunglasses; Final  ODE/DOED/DSDB 2208 10/09/1998 |
| (417) Information for Keratome Manufacturers Regarding LASIK; Final  Guidance for Industry ODE/DOED/DSDB 1376 06/21/2001 |
| (418) Ophthalmoscope Guidance ODE/DOED/DSDB 1241 07/08/1998 |
| (419) Retinoscope Guidance; Final ODE/DOED/DSDB 1240 07/08/1998 |
| (420) Slit Lamp Guidance; Final ODE/DOED/DSDB 1242 07/08/1998 |
| (421) Third Party Review Guidance for Phacofragmentation System  Device Premarket Notification (510(k)) ODE/DOED/DSDB 2197 01/31/1997 |
| (422) Third Party Review Guidance for Vitreous Aspiration and  Cutting Device Premarket Notification (510(k)) ODE/DOED/DSDB 2196  01/31/1997 |
| (423) Class II Special Controls Guidance Document: Endolymphatic  Shunt Tube with Valve; Guidance for Industry and FDA ODE/DOED/ENTB  791 04/29/2002 |
| (424) Class II Special Controls Guidance Document: Transcutaneous  Air Conduction Hearing Aid System (TACHAS); Guidance for Industry  and FDA ODE/DOED/ENTB 1414 11/07/2002 |
| (425) Guidance for Manufacturers Seeking Marketing Clearance of Ear,  Nose, and Throat Endoscope Sheaths Used as Protective Barriers;  Final ODE/DOED/ENTB 954 03/12/2000 |
| (426) Implantable Middle Ear Hearing Device; Guidance for Industry  and FDA ODE/DOED/ENTB 1406 08/01/2003 |
| (427) Tinnitus Masker Devices—Class II Special Controls Guidance  Document—Draft Guidance for Industry and FDA Staff ODE/DOED/ENTB  1555 10/08/2005 |
| (428) Tympanostomy Tubes, Submission Guidance for a 510(k) Premarket  Notification; Final ODE/DOED/ENTB 930 01/14/1998 |
| (429) Vocal Fold Medialization Devices—Premarket Notification  [510(k)] Submissions—Guidance for Industry and FDA Staff  ODE/DOED/ENTB 1535 02/13/2004 |
| (430) Aqueous Shunts—510(k) Submissions; Final ODE/DOED/ICIB 2236  11/16/1998 |
| (431) Guidance on 510(k) Submissions for Keratoprostheses, Final  ODE/DOED/ICIB 1351 03/03/1999 |
| (432) Important Information About Rophae Intraocular Lenses  ODE/DOED/ICIB 811 08/20/1992 |
| (433) Guidance for Premarket Submissions of Orthokeratology Rigid  Gas Permeable Contact Lenses; Final ODE/DOED/VEDB 1134 04/10/2000 |
| (434) New FDA Recommendations & Results of Contact Lens Study (7 day  letter) ODE/DOED/VEDB 265 05/30/1989 |
| (435) Premarket Notification [510(k)] Guidance Document for Class II  Daily Wear Contact Lenses ODE/DOED/VEDB 896 06/28/1994 |
| (436) Premarket Notification 510(k) Guidance for Contact Lens Care  Products ODE/DOED/VEDB 674 05/01/1997 |
| (437) Revised Procedures for Adding Lens Finishing Laboratories to  Approved Premarket Approval Applications for Class III Rigid Gas  Permeable Contact Lenses for Extended Wear; Final ODE/DOED/VEDB 1249  08/11/1998 |
| (438) Bone Sonometer PMA Applications; Final Guidance for Industry  and FDA ODE/DRARD 1377 06/21/2001 |
| (439) Criteria for Significant Risk Investigations of Magnetic  Resonance Diagnostic Devices—Guidance for Industry and FDA Staff  ODE/DRARD 793 07/14/2003 |
| (440) Guidance for the Submission of 510(k)s for Solid State X-ray  Imaging Devices; Final ODE/DRARD 644 08/06/1999 |
| (441) Guidance for the Submission of Premarket Notifications for  Emission Computed Tomography Devices and Accessories (SPECT and PET)  and Nuclear Tomography Systems; Final ODE/DRARD 2240 12/03/1998 |
| (442) Guidance for the Submission of Premarket Notifications for  Magnetic Resonance Diagnostic Devices; Final ODE/DRARD 340  11/14/1998 |
| (443) Guidance for the Submission of Premarket Notifications for  Medical Image Management Devices ODE/DRARD 416 07/27/2000 |
| (444) Guidance for the Submission of Premarket Notifications for  Photon-Emitting Brachytherapy Sources ODE/DRARD 1177 08/02/2000 |
| (445) Guidance for the Submission of Premarket Notifications for  Radionuclide Dose Calibrators; Final ODE/DRARD 2238 11/20/1998 |
| (446) Harmonic Imaging with/without Contrast—Premarket  Notification; Final ODE/DRARD 2234 11/16/1998 |
| (447) Information for Manufacturers Seeking Marketing Clearance of  Diagnostic Ultrasound Systems and Transducers ODE/DRARD 560  09/30/1997 |
| (448) Letter: Notice to Manufacturers of Bone Mineral Densitometers  ODE/DRARD 552 09/25/1997 |
| (449) Premarket Applications for Digital Mammography Systems; Final  Guidance for Industry and FDA ODE/DRARD 983 02/16/2001 |
| (450) Reviewer Guidance for Automatic X-Ray Film Processor 510(k)  ODE/DRARD 788 02/01/1990 |
| (451) Simplified 510(k) procedures for certain radiology devices:  12/21/93 letter from L Yin, ODE/DRAERD, to NEMA ODE/DRARD 708  12/21/1993 |
| (452) Class II Special Controls Guidance Document: Tissue Culture  Media for Human ex vivo Tissue and Cell Culture Processing  Applications; Final Guidance for Industry and FDA Reviewers  ODE/DRARD/GRDB 1325 05/16/2001 |
| (453) Class II Special Controls Guidance Document; Ingestible  Telemetric Gastrointestinal Capsule Imaging System; Final Guidance  for Industry and FDA ODE/DRARD/GRDB 1385 11/28/2001 |
| (454) Guidance for Industry and CDRH Reviewers on the Content of  Premarket Notifications for Hemodialysis Delivery Systems; Final  ODE/DRARD/GRDB 2202 08/07/1998 |
| (455) Guidance for Investigational Device Exemptions for Solutions  for Hypothermic Flushing, Transport, and Storage of Organs for  Transplantation; Final Guidance for Industry and FDA Reviewers  ODE/DRARD/GRDB 1164 01/16/2001 |
| (456) Guidance for the Content of Premarket Notification for  Conventional and High Permeability Hemodialyzers; Final  ODE/DRARD/GRDB 421 08/07/1998 |
| (457) Guidance for the Content of Premarket Notifications for Metal  Expandable Biliary Stents; Final ODE/DRARD/GRDB 2243 02/05/1998 |
| (458) Guidance for the Content of Premarket Notifications for Water  Purification Components and Systems for Hemodialysis ODE/DRARD/GRDB  842 05/30/1997 |
| (459) Class II Special Controls Guidance Document for Clitoral  Engorgement Devices ODE/DRARD/OGDB 1144 07/03/2000 |
| (460) Class II Special Controls Guidance Document: Breast Lesion  Documentation System—Guidance for Industry and FDA Staff  ODE/DRARD/OGDB 1202 07/28/2003 |
| (461) Class II Special Controls Guidance for Home Uterine Activity  Monitors; Final Guidance for Industry and FDA Reviewers  ODE/DRARD/OGDB 820 03/09/2001 |
| (462) Guidance ('Guidelines') for Evaluation of Fetal Clip Electrode  ODE/DRARD/OGDB 244 03/08/1977 |
| (463) Guidance ('Guidelines') for Evaluation of Hysteroscopic  Sterilization Devices ODE/DRARD/OGDB 248 05/10/1978 |
| (464) Guidance ('Guidelines') for Evaluation of Laparoscopic Bipolar  and Thermal Coagulators (and Accessories) ODE/DRARD/OGDB 232  05/01/1978 |
| (465) Guidance ('Guidelines') for Evaluation of Tubal Occlusion  Devices ODE/DRARD/OGDB 245 11/22/1977 |
| (466) Guidance for Industry and FDA Staff—Class II Special  Controls Guidance Document: Assisted Reproduction Laser Systems  ODE/DRARD/OGDB 1539 12/28/2004 |
| (467) Guidance for Industry and FDA Staff—Menstrual Tampons and  Pads: Information for Premarket Notification Submissions (510(k)s)  ODE/DRARD/OGDB 166 07/27/2005 |
| (468) Guidance for Resorbable Adhesion Barrier Devices for Use in  Abdominal and/or Pelvic Surgery; Guidance for Industry  ODE/DRARD/OGDB 1356 06/18/2002 |
| (469) Guidelines for Evaluation of Non-Drug IUDs ODE/DRARD/OGDB 641  09/28/1976 |
| (470) Hysteroscopes and Gynecology Laparoscopes—Submission  Guidance for a 510(k) ODE/DRARD/OGDB 907 03/07/1996 |
| (471) Hysteroscopes and Laparoscopic Insufflators: Submission  Guidance for a 510(k) ODE/DRARD/OGDB 1907 08/01/1995 |
| (472) Latex Condoms for Men—Information for 510(k) Premarket  Notifications: Use of Consensus Standards for Abbreviated  Submissions ODE/DRARD/OGDB 1250 07/23/1998 |
| (473) Letter to Manufacturers of Falloposcopes ODE/DRARD/OGDB 1344  09/05/1996 |
| (474) Letter to Manufacturers of Prescription Home Monitors for  Non-Stress Tests ODE/DRARD/OGDB 1342 09/06/1996 |
| (475) Premarket Testing Guidelines for Female Barrier Contraceptive  Devices also intended to prevent sexually transmitted diseases  ODE/DRARD/OGDB 384 04/04/1990 |
| (476) Testing guidance for Male Condoms Made from New Material  (Non-Latex) ODE/DRARD/OGDB 455 06/29/1995 |
| (477) Thermal Endometrial Ablation Devices (Submission Guidance for  an IDE) ODE/DRARD/OGDB 547 03/14/1996 |
| (478) Uniform Contraceptive Labeling; Final ODE/DRARD/OGDB 1251  07/23/1998 |
| (479) Vascular and Neurovascular Embolization Devices—Class II  Special Controls Guidance Document—Guidance for Industry and FDA  Staff ODE/DRARD/OGDB ODE/DGRND/PRSB ODE/DCD/PVDB 1234 12/29/2004 |
| (480) Bone Sonometers—Class II Special Controls Guidance Document—Draft Guidance for Industry and FDA Staff ODE/DRARD/RDB 1547  02/15/2006 |
| (481) 510(k) Checklist for Sterile Lubricating Jelly Used With  Transurethral Surgical Instruments ODE/DRARD/ULDB 892 09/19/1994 |
| (482) Checklist for Mechanical Lithotripters and Stone Dislodgers  used in Gastroenterology and Urology ODE/DRARD/ULDB 98 11/01/1994 |
| (483) Class II Special Controls Guidance Document: External Penile  Rigidity Devices ODE/DRARD/ULDB 1231 12/28/2004 |
| (484) Guidance for the Content of Premarket Notifications (510(k)s)  for Extracorporeal Shock Wave Lithotripters Indicated for the  Fragmentation of Kidney and Ureteral Calculi ODE/DRARD/ULDB 1226  08/09/2000 |
| (485) Guidance for the Content of Premarket Notifications for Biopsy  Devices Used in Gastroenterology and Urology ODE/DRARD/ULDB 482  02/10/1993 |
| (486) Guidance for the Content of Premarket Notifications for  Conventional and Antimicrobial Foley Catheters ODE/DRARD/ULDB 97  09/12/1994 |
| (487) Guidance for the Content of Premarket Notifications for  Intracorporeal Lithotripters; Final ODE/DRARD/ULDB 2235 11/30/1998 |
| (488) Guidance for the Content of Premarket Notifications for Penile  Rigidity Implants; Final ODE/DRARD/ULDB 177 01/16/2000 |
| (489) Guidance for the Content of Premarket Notifications for  Ureteral Stents ODE/DRARD/ULDB 431 02/10/1993 |
| (490) Guidance for the Content of Premarket Notifications for Urine  Drainage Bags ODE/DRARD/ULDB 96 06/07/1994 |
| (491) Guidance for the Content of Premarket Notifications for  Urodynamic/Uroflowmetry Systems ODE/DRARD/ULDB 490 07/29/1994 |
| (492) Analyte Specific Reagents; Small Entity Compliance Guidance;  Guidance for Industry OIVD 1205 02/26/2003 |
| (493) Assessing the Safety/Effectiveness of Home-use In Vitro  Diagnostic Devices (IVDs): Draft Points to Consider Regarding  Labeling and Premarket Submissions OIVD 272 10/01/1988 |
| (494) Determination of Intended Use for 510(k) Devices; Guidance for  CDRH Staff OIVD 857 12/03/2002 |
| (495) Guidance for Administrative Procedures for CLIA Categorization  OIVD 1143 08/14/2000 |
| (496) Guidance for Industry—Abbreviated 510(k) Submissions for In  Vitro Diagnostic Calibrators; Final OIVD 1247 02/22/1999 |
| (497) Guidance for Industry and FDA Staff; Replacement Reagent and  Instrument Family Policy OIVD 950 12/11/2003 |
| (498) Guidance on Labeling for Laboratory Tests; Draft OIVD 1352  06/24/1999 |
| (499) Guideline for the Manufacture of In Vitro Diagnostic Products  OIVD 918 01/10/1994 |
| (500) Letter to IVD Manufacturers on Streamlined PMA; Final OIVD  1395 12/22/1997 |
| (501) Points to Consider for Collection of Data in Support of  In-Vitro Device Submissions for 510(k) Clearance OIVD 95 09/26/1994 |
| (502) Points to Consider for Review of Calibration and Quality  Control Labeling for In Vitro Diagnostic Devices/Cover Letter dated  3/14/1996 OIVD 553 02/01/1996 |
| (503) Points to Consider Guidance Document on Assayed and Unassayed  Quality Control Material; Draft OIVD 2231 02/03/1999 |
| (504) Recommendations for Clinical Laboratory Improvement Amendments  of 1988 (CLIA) Waiver Applications—Draft Guidance for Industry and  FDA Staff OIVD 1171 09/07/2005 |
| (505) Draft Guidance for Industry and FDA Staff—Pharmacogenetic  Tests and Genetic Tests for Heritable Markers CBER  CDER  OIVD 1549 02/09/2006 |
| (506) Format for Traditional and Abbreviated 510(k)s—Guidance for  Industry and FDA Staff OIVD ODE 1567 08/12/2005 |
| (507) Guidance for Third Parties and FDA Staff; Third Party Review  of Premarket Notifications OIVD ODE 2237 09/28/2004 |
| (508) Premarket Approval Application Filing Review—Guidance for  Industry and FDA Staff OIVD ODE 297 05/01/2003 |
| (509) Guidance for the Content of Premarket Submissions for Software  Contained in Medical Devices—Guidance for Industry and FDA Staff  CBER  OIVD ODE 337 05/11/2005 |
| (510) Breath Nitric Oxide Test System—Class II Special Controls  Guidance Document OIVD/DCTD 1211 07/07/2003 |
| (511) Class II Special Control Guidance Document for B-Type  Natriuretic Peptide Premarket Notifications; Final Guidance for  Industry and FDA Reviewers OIVD/DCTD 1072 11/30/2000 |
| (512) Class II Special Controls Guidance Document: Cyclosporine and  Tacrolimus Assays; Guidance for Industry and FDA OIVD/DCTD 1380  09/16/2002 |
| (513) Draft Guidance on the Labeling for Over-the-Counter Sample  Collection Systems for Drugs of Abuse Testing OIVD/DCTD 1359  12/21/1999 |
| (514) Drug Metabolizing Enzyme Genotyping System—Class II Special  Controls Guidance Document—Guidance for Industry and FDA Staff  OIVD/DCTD 1551 03/10/2005 |
| (515) Guidance for 510(k)s on Cholesterol Tests for Clinical  Laboratory, Physicians' Office Laboratory, and Home Use OIVD/DCTD  605 07/14/1995 |
| (516) Guidance for Industry—Review Criteria for Assessment of C-Reactive Protein (CRP), High Sensitivity C-Reactive Protein  (hsCRP) and Cardiac C-Reactive Protein (cCRP) Assays OIVD/DCTD 1246  09/22/2005 |
| (517) Guidance for Industry and FDA Staff; Class II Special Controls  Guidance Document: Sirolimus Test Systems OIVD/DCTD 1300 09/30/2004 |
| (518) Guidance for Industry In Vitro Diagnostic Bicarbonate/Carbon  Dioxide Test System; Final OIVD/DCTD 1102 07/06/1998 |
| (519) Guidance for Industry In Vitro Diagnostic Chloride Test  System; Final OIVD/DCTD 1103 07/06/1998 |
| (520) Guidance for Industry In Vitro Diagnostic Creatinine Test  System; Final OIVD/DCTD 1104 07/02/1998 |
| (521) Guidance for Industry In Vitro Diagnostic Glucose Test System;  Final OIVD/DCTD 1105 07/06/1998 |
| (522) Guidance for Industry In Vitro Diagnostic Potassium Test  System; Final OIVD/DCTD 1107 07/06/1998 |
| (523) Guidance for Industry In Vitro Diagnostic Sodium Test System;  Final OIVD/DCTD 1109 07/06/1998 |
| (524) Guidance for Industry In Vitro Diagnostic Urea Nitrogen Test  System; Final OIVD/DCTD 1110 07/06/1998 |
| (525) Guidance for Over-the-Counter (OTC) Human Chorionic  Gonadotropin (hCG) 510(k)s OIVD/DCTD 1172 07/22/2000 |
| (526) Instrumentation for Clinical Multiplex Test Systems—Class II  Special Controls Guidance Document—Guidance for Industry and FDA  Staff OIVD/DCTD 1546 03/10/2005 |
| (527) Newborn Screening Test Systems for Amino Acids, Free  Carnitine, and Acylcarnitines Using Tandem Mass Spectrometry—Class  II Special Controls Guidance Document OIVD/DCTD 1301 12/24/2004 |
| (528) Points to Consider for Portable Blood Glucose Monitoring  Devices Intended for Bedside Use in the Neonate Nursery OIVD/DCTD  122 02/20/1996 |
| (529) Premarket Submission and Labeling Recommendations for Drugs of  Abuse Screening Tests—Draft Guidance for Industry and FDA Staff  OIVD/DCTD 152 12/02/2003 |
| (530) Review Criteria for Assessment of Portable Blood Glucose In  Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase, or  Hexokinase Methodology OIVD/DCTD 604 02/14/1996 |
| (531) Review Criteria for Assessment of Professional Use Human  Chorionic Gonadotropin (hCG) In Vitro Diagnostic Devices (IVDs)  OIVD/DCTD 1345 11/06/1996 |
| (532) 510(k) Submissions for Coagulation Instruments—Guidance for  Industry and FDA Staff OIVD/DIHD 1223 06/19/2003 |
| (533) CFTR Gene Mutation Detection Systems—Guidance for Industry  and FDA Staff—Class II Special Controls Guidance Document  OIVD/DIHD 1564 10/26/2005 |
| (534) Class II Special Control Guidance Document for  Anti-Saccharomyces cerevisia (S. cerevisiae) Antibody (ASCA)  Premarket Notifications OIVD/DIHD 1183 08/23/2000 |
| (535) Class II Special Controls Guidance Document: AFP-L3%  Immunological Test Systems OIVD/DIHD 1570 10/03/2005 |
| (536) Class II Special Controls Guidance Document: Factor V Leiden  DNA Mutation Detection Systems—Guidance for Industry and FDA Staff  OIVD/DIHD 1236 03/16/2004 |
| (537) Class II Special Controls Guidance Document: Premarket  Notifications for Automated Differential Cell Counters for Immature  or Abnormal Blood Cells; Final Guidance for Industry and FDA  OIVD/DIHD 1184 12/04/2001 |
| (538) Class II Special Controls Guidance Document: RNA Preanalytical  Systems (RNA Collection, Stabilization and Purification Systems for  RT-PCR used in Molecular Diagnostic Testing) OIVD/DIHD 1563  08/25/2005 |
| (539) Document for Special Controls for Erythropoietin Assay  Premarket Notifications [510(k)s]; Final OIVD/DIHD 2241 04/28/1999 |
| (540) Draft Guidance Document for 510(k) Submission of Fecal Occult  Blood Tests OIVD/DIHD 772 07/29/1992 |
| (541) Draft Guidance Document for 510(k) Submission of  Glycohemoglobin (Glycated or Glycosylated) Hemoglobin for IVDs  OIVD/DIHD 658 09/30/1991 |
| (542) Draft Guidance Document for 510(k) Submission of  Immunoglobulins A,G,M,D and E Immunoglobulin System In Vitro Devices  OIVD/DIHD 785 09/01/1992 |
| (543) Draft Guidance for 510(k) Submission of Lymphocyte  Immunophenotyping IVDs using Monoclonal Antibodies OIVD/DIHD 475  09/26/1991 |
| (544) Guidance Document for the Submission of Tumor Associated  Antigen Premarket Notification [510(k)] to FDA OIVD/DIHD 957  09/19/1996 |
| (545) Guidance for Industry and FDA Staff—Class II Special  Controls Guidance Document: Automated Fluorescence in situ  Hybridization (FISH) Enumeration Systems OIVD/DIHD 1550 03/23/2005 |
| (546) Guidance for Submission of Immunohistochemistry Applications  to the FDA; Final OIVD/DIHD 364 06/03/1998 |
| (547) Immunomagnetic Circulating Cancer Cell Selection and  Enumeration System—Class II Special Controls Guidance Document—Guidance for Industry and FDA Staff OIVD/DIHD 1531 05/11/2004 |
| (548) In Vitro Diagnostic Fibrin Monomer Paracoagulation Test; Final  OIVD/DIHD 2242 04/27/1999 |
| (549) Points to Consider for Cervical Cytology Devices OIVD/DIHD 968  07/25/1994 |
| (550) Radioallergosorbent Test (RAST) Methods for Allergen-Specific  Immunoglobulin E (IgE) 510(k)s; Final Guidance for Industry and FDA  OIVD/DIHD   08/22/2001 |
| (551) Review Criteria for Assessment of Alpha-Fetoprotein (AFP) in  vitro Diagnostic Devices for Fetal Open Neural Tube Defects Using  Immunological Test Methodologies OIVD/DIHD 459 07/15/1994 |
| (552) Review Criteria for Assessment of Cytogenetic Analysis Using  Automated and Semi-Automated Chromosome Analyzers OIVD/DIHD 417  07/15/1991 |
| (553) Review Criteria for Assessment of Rheumatoid Factor(RF) In  Vitro Diagnostic Devices Using Engzyme-Linked Immunoassay (EIA),  Enzyme Linked Immunosorbent Assay (ELISA), Particle Agglutination  Tests, and Laser and Rate Nephelometry OIVD/DIHD 165 02/21/1997 |
| (554) Review Criteria for Blood Culture Systems OIVD/DIHD 82  08/12/1991 |
| (555) Review Criteria for In Vitro Diagnostic Devices for Detection  of IGM Antibodies to Viral Agents OIVD/DIHD 527 08/01/1992 |
| (556) Review Criteria for In Vitro Diagnostic Devices for the  Assessment of Thyroid Autoantibodies using Indirect  Immunofluorescence Assay (IFA), Indirect Hemagglutination Assay  (IHA), Radioimmunoasay (RIA), and Enzyme Linked Immunosorbent Assay  (ELISA) OIVD/DIHD 51 02/01/1994 |
| (557) Review Criteria for In Vitro Diagnostic Devices that Utilize  Cytogenetic In Situ Hybridization Technology for the Detection of  Human Genetic Mutations (Germ Line and Somatic) OIVD/DIHD 980  02/15/1996 |
| (558) Review Criteria for the Assessment of Anti-nuclear Antibodies  (ANA) In-Vitro Diagnostic Devices Using Indirect Immunofluorescence  Assay (IFA), Immunodiffusion (IMD) and Enzyme Linked Immunosorbant  Assay (ELISA) OIVD/DIHD 848 09/01/1992 |
| (559) Class II Special Controls Guidance Document: Antimicrobial  Susceptibility Test (AST) Systems; Guidance for Industry and FDa  OIVD/DMD 631 02/05/2003 |
| (560) Class II Special Controls Guidance Document: Endotoxin Assay  OIVD/DMD 1222 10/31/2003 |
| (561) Draft Guidance for Industry and Food and Drug Administration  Staff; Class II Special Controls Guidance Document: Herpes Simplex  Virus Types 1 and 2 Serological Assays OIVD/DMD 1305 01/09/2006 |
| (562) Guidance for Industry and FDA Staff—Class II Special  Controls Guidance Document: Hepatitis A Virus Serological Assays  OIVD/DMD 1536 02/09/2006 |
| (563) Guidance for Industry and FDA Staff—Class II Special  Controls Guidance Document: Serological Reagents for the Laboratory  Diagnosis of West Nile Virus OIVD/DMD 1206 10/30/2003 |
| (564) Guidance for Industry and FDA Staff; Class II Special Controls  Guidance Document: Serological Assays for the Detection of  Beta-Glucan OIVD/DMD 1825 09/23/2004 |
| (565) Nucleic Acid Based In Vitro Diagnostic Devices for Detection  of Microbial Pathogens—Draft Guidance for Industry and FDA Staff  OIVD/DMD 1560 12/08/2005 |
| (566) Review Criteria for Assessment of Antimicrobial Susceptibility  Test Discs OIVD/DMD 1631 10/30/1996 |
| (567) Review Criteria for Assessment of In Vitro Diagnostic Devices  for Direct Detection of Chlamydiae in Clinical Specimens OIVD/DMD  778 01/01/1992 |
| (568) Review Criteria for Assessment of In Vitro Diagnostic Devices  for Direct Detection of Mycobacterium Spp. [Tuberculosis (TB)]  OIVD/DMD 862 07/06/1993 |
| (569) Review Criteria for Assessment of Laboratory Tests for the  Detection of Antibodies to Helicobacter pylori OIVD/DMD 588  09/17/1992 |
| (570) Review Criteria for Devices Assisting in the Diagnosis of C.  Difficile Associated Diseases OIVD/DMD 629 05/31/1990 |
| (571) Review Criteria for Devices Intended for the Detection of  Hepatitis B 'e' Antigen and Antibody to HBe OIVD/DMD 554 12/30/1991 |
| (572) Review Criteria For Premarket Approval of In Vitro Diagnostic  Devices for Detection of Antibodies to Parvovirus B19 OIVD/DMD 770  05/15/1992 |
| (573) Addendum to the Instructions for Completing FDA form 3500A  with Coding Manual (MEDWATCH)(MDR) OSB   06/09/1999 |
| (574) Perspectives on Clinical Studies for Medical Device  Submissions (Statistical) OSB 78 |
| (575) PMA Review Statistical Checklist OSB 84 |
| (576) Statistical Guidance for Clinical Trials of Non Diagnostic  Medical Devices OSB 476 01/01/1996 |
| (577) Statistical Guidance on Reporting Results from Studies  Evaluating Diagnostic Tests; Draft Guidance for Industry and FDA  Reviewers OSB/DB 1428 03/12/2003 |
| (578) Guidance for Industry on the Testing of Metallic Plasma  Sprayed Coatings on Orthopedic Implants to Support Reconsideration  of Postmarket Surveillance Requirements OSB/DPS 946 02/02/2000 |
| (579) Guidance on Criteria and Approaches for Postmarket  Surveillance OSB/DPS 9 11/02/1998 |
| (580) Guidance on Procedures for Review of Postmarket Surveillance  Submissions OSB/DPS 317 02/19/1998 |
| (581) Guidance on Procedures to Determine Application of Postmarket  Surveillance Strategies OSB/DPS 316 02/19/1998 |
| (582) Procedures for Handling Post-Approval Studies Imposed by PMA  Order—Draft Guidance for Industry and FDA Staff OSB/DPS    09/15/2005 |
| (583) SMDA to FDAMA: Guidance on FDA's Transition Plan for Existing  Postmarket Surveillance OSB/DPS 318 11/02/1998 |
| (584) Hospital Bed System Dimensional and Assessment Guidance to  Reduce Entrapment—Guidance for Industry and FDA Staff OSB/DPS OCER/DDUPSA 1537 03/10/2006 |
| (585) Common Problems: Baseline Reports and MedWatch Form 3500A  (letter to manufacturers updated) OSB/DSS 379 |
| (586) Instructions for Completing FDA Form 3500A with Coding Manual  for Form 3500A (MEDWATCH) OSB/DSS 853 04/04/2001 |
| (587) Instructions for Completing Form 3417: Medical Device  Reporting Baseline Report [MDR] OSB/DSS 1061 03/31/1997 |
| (588) MDR Guidance Document No. 1 - IOL - E1996004 OSB/DSS 216  08/07/1996 |
| (589) Medical Device Reporting: An Overview OSB/DSS 509 04/01/1996 |
| (590) MEDWATCH FDA Form 3500A For Use By User Facilities,  Distributors and Manufacturers for Mandatory Reporting OSB/DSS 854  06/01/1993 |
| (591) Variance from Manufacturer Report Number Format OSB/DSS    08/12/1996 |
| (592) Variance from Manufacturer Report Number Format [MDR letter]  OSB/DSS 1059 07/16/1996 |
| (593) Guidance for Industry: Medical Device Reporting—Alternative  Summary Reporting (ASR) Program OSB/DSS/RSMB 315 10/19/2000 |
| (594) Guidance on Adverse Event Reporting for Hospitals that  Reprocess Devices Intended by the Original Equipment Manufacturer  for Single Use OSB/DSS/RSMB 1334 04/24/2001 |
| (595) Medical Device Reporting - Remedial Action Exemption; Guidance  for Industry and FDA OSB/DSS/RSMB 188 09/26/2001 |
| (596) Needlesticks—Medical Device Reporting Guidance for User  Facilities, Manufacturers, and Importers OSB/DSS/RSMB 250 11/12/2002 |
| (597) CDRH Standard Operating Procedures for the Identification and  Evaluation of Candidate Consensus Standards for Recognition; Final  Guidance for Industry OSEL 616 06/20/2001 |
| (598) Draft Document—A Primer on Medical Device Interactions with  Magnetic Resonance Imaging Systems OSEL 952 02/07/1997 |
| (599) Frequently Asked Questions on the Recognition of Consensus  Standards; Guidance for Industry and for FDA Staff OSEL 109  07/22/2002 |
| (600) Recognition and Use of Consensus Standards; Final Guidance for  Industry and FDA OSEL 321 06/20/2001 |
| (601) Guidance for Industry Guidance on FDA's Expectations of  Medical Device Manufacturers Concerning the Year 2000 Date Problem  OSEL/DECS 2000 05/15/1998 |
| (602) Immunotoxicity Testing Guidance OSEL/DLS 635 05/06/1999 |
| (603) 21 CFR Part 11; Electronic Records; Electronic Signatures,  Glossary of Terms; Draft Guidance for Industry OUT   09/24/2001 |
| (604) 21 CFR Part 11; Electronic Records; Electronic Signatures,  Validation; Draft Guidance for Industry OUT   09/24/2001 |
| (605) Combination Products—Timeliness of Premarket Reviews—Dispute Resolution Guidance—Draft Guidance for Industry OUT    05/04/2004 |
| (606) Computerized Systems Used in Clinical Trials OUT   04/01/1999 |
| (607) Draft Guidance for Industry on Electronic Records; Electronic  Signatures, Electronic Copies of Electronic Records OUT   11/12/2002 |
| (608) Guidance for Industry and FDA Staff: Application User Fees for  Combination Products OUT   04/21/2005 |
| (609) Information Sheet Guidance for IRB's—Frequently Asked  Questions about IRB Review of Medical Devices OUT   01/01/2006 |
| (610) Information Sheet Guidance for IRB's—Significant Risk and  Nonsignificant Risk Medical Device Studies OUT   01/01/2006 |
| (611) Small Business Guide to FDA (FDA 96-1092) OUT 16 01/01/1996 |

**V.  Center for Food Safety and Applied Nutrition (CFSAN)**

For information on a specific guidance document or to obtain a hard copy, contact: Industry Activities Staff, Center for Food Safety and Applied Nutrition/FDA, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2600, *http://www.cfsan.fda.gov/~dms/guidance.html* .

No CFSAN guidance documents were withdrawn from January 5, 2005, to January 5, 2006.

The following is a copy of a list of current CFSAN guidance documents obtained from the FDA Web site as of March 14, 2006.

|  |
| --- |
| Recently Issued Guidance |
| March 1, 2006: Draft Guidance: Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables (Added to Produce) |
| March 1, 2006: Frequently Asked Questions about FDA's Regulation of Infant   Formula   (Updated in Infant Formula) |
| February 17, 2006: Whole Grain Label Statements   (Added to Food Labeling) |
| January 30, 2006: Redbook 2000—Chapter IV.C.6: Carcinogenicity Studies with  Rodents   (Updated in Food and Color Additives) |
| December 30, 2005: Requesting an Extension to Use Existing Label Stock after   the Trans Fat Labeling Effective Date of January 1, 2006   (Added to Food Labeling) |
| December 22, 2005: Lead in Candy Likely To Be Consumed Frequently by Small   Children: Recommended Maximum Level and Enforcement Policy   (Added to Chemical and Pesticide Contaminants) |
| December 14, 2005: Questions and Answers Regarding Food Allergens, including   the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 2)   (Added to Food Labeling) |
| General Publications |
| Compliance Policy Guides Manual (August 2000; Updated April       2001) Consolidates the Administrative Guidelines Manual. Lists levels of       contamination at which regulatory actions will be invoked. Print version       available from NTIS. Their order numbers are:  Foods and Cosmetics Order No. PB96-920500  Drugs and Biologics Order No. PB96-920500  Veterinary Medicine Order No. PB96-920800 Medical and Radiological Devices Order No. PB96-920900       Source: National Technical Information Service |
| Compliance Programs Guidance Manual (March 1995) Manual. Contains       inspectional and analytical directives implemented by FDA Field Units.       Provides direction for general enforcement of laws and regulations.      Order No. PB95-915499 (manual only)      Source: National Technical Information Service |
| FDA Recall Policy (2002) Explains the three classes of recalls and       discusses FDA's role in the recall process.      Source: Industry Activities Staff |
| Guidance for FDA Staff: The Leveraging Handbook; An Agency Resource for       Effective Collaborations |
| Guidance for Small Businesses: Submission of Comments for CFSAN Rulemaking |
| Investigations Operations Manual (May 1996) Manual. Provides standard       operation procedures for FDA Investigators. The inspectional methods cover       sanitation, micro problems, labeling, standards, and GMP's.      Order No. PB-95-913399       Source: National Technical Information Service |
| Regulatory Procedures Manual (August 1997) Contains directives for recalls,       legal actions, and cooperative agreements with states, such as those under       the Public Health Service.      Order No. PB95-265534      Source: National Technical Information Service |
| Chemical and Pesticide Contaminants Publications |
| Lead in Candy Likely To Be Consumed Frequently by Small Children:       Recommended Maximum Level and Enforcement Policy (December 22, 2005) |
| Channels of Trade Policy for Commodities With Residues of Pesticide       Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified       by the Environmental Protection Agency Pursuant to Dietary Risk       Considerations (May 2005) |
| Channels of Trade Policy for Commodities with Vinclozolin Residues (June       12, 2002) |
| FDA Recommendations for Sampling and Testing Yellow Corn and Dry-Milled       Yellow Corn Shipments for Cry9C Protein Residues (January 19, 2001) |
| Channels of Trade Policy for Commodities with Methyl Parathion Residues       (December 2000) |
| Action Levels for Poisonous or Deleterious Substances in Human Food and       Animal Feed (2000) Booklet. Lists allowable action levels for contaminants       in food and feed.      Source: Industry Activities Staff |
| Pesticides Analytical Manual (1999) Contains the procedures and methods       used in FDA labs for regulatory examination of food and feed samples to       determine compliance with the FD&C Act.      Volume 1—Order No.PB94-911899      Source: National Technical Information Service |
| Guidance for Industry: Letter to Manufacturers, Importers, and       Distributors of Imported Candy and Candy Wrappers (June 13, 1995) |
| FDA Advisory for Deoxynivanol (DON) in Finished Wheat Products Intended       for Human Consumption and in Grain and Grain By-Products for Animal Feed       (September 16, 1993) Office of Plant & Dairy Foods & Beverages  Food and Drug Administration (HFS-306)  5100 Paint Branch Parkway  College Park, MD 20740  (301) 436-2367  See also: Compliance Policy Guides—Guidance for FDA Staff on Guidance       Levels for Radionuclides in Domestic and Imported Foods July 2004 |
| Cosmetic Publications |
| FDA's Cosmetic Labeling Manual (October 1991) Booklet. A summary of       regulatory requirements for labeling of cosmetics marketed in the United       States. Available from:        Food and Drug Administration       Office of Cosmetics and Colors (HFS-100)      5100 Paint Branch Parkway      College Park, MD 20740-3235 |
| Cosmetics Processors and Transporters: Cosmetics Security Preventive       Measures Guidance (December 17, 2003) |
| Labeling for Topically Applied Cosmetic Products Containing Alpha Hydroxy       Acids as Ingredients (January 10, 2005) |
| Dietary Supplements Publications |
| A Dietary Supplement Labeling Guide (April 2005) |
| Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6)       of the Federal Food, Drug, and Cosmetic Act (November 2004) |
| Interim Procedures for Qualified Health Claims in the Labeling of       Conventional Human Food and Human Dietary Supplements (July 10, 2003) |
| Interim Evidence-based Ranking System for Scientific Data (July 10, 2003) |
| Structure/Function Claims: Small Entity Compliance Guide (January 9, 2002) |
| Statement of Identity, Nutrition Labeling, and Ingredient Labeling of       Dietary Supplements Small Entity Compliance Guide (January 1999) Source:       Industry Activities Staff |
| Significant Scientific Agreement in the Review of Health Claims for       Conventional Foods and Dietary Supplements (December 1999) Source: Office       of Nutritional Products, Labeling & Dietary Supplements |
| Notification of a Health Claim or Nutrient Content Claim Based on an       Authoritative Statement of a Scientific Body (July 1998) Source: Office of       Food Labeling |
| Iron-Containing Supplements and Drugs: Label Warning Statements: Small       Entity Compliance Guide (October 17, 2003) |
| Food and Color Additives      Publications |
| Providing Regulatory Submissions in Electronic Format—General Considerations (October 2003) |
| Providing Food and Color Additive Petitions in Electronic Format (July 2001) |
| Electronic Submission Forms (July 2001) |
| FDA's Policy for Foods Developed by Biotechnology (1995) |
| Partial List of Enzyme Preparations That are Used in Foods (2001) |
| Partial List of Microorganisms and Microbial-Derived Ingredients That Are Used in Food (2001) |
| Use of Antibiotic Resistance Marker Genes in Transgenic Plants (September 1998) |
| Enzyme Preparations: Chemistry Recommendations For Food Additive and GRAS Affirmation Petitions (January 1993) Describes requirements for chemistry data needed to support food additive and GRAS petitions for the preparation of enzymes used in processing food.Source: Office of Premarket Approval |
| Submitting Requests under 21 CFR 170.39 Threshold of Regulation for Substances used in Food Contact Articles (April 2005) Lists the information that should be submitted to FDA when requesting that the agency review a specific use of a food contact article to determine whether its components will require regulation as a food additive. Source: Office of Premarket Approval |
| Points to Consider for the Use of Recycled Plastics in Food Packaging: Chemistry Considerations (December 1992) This document provides assistance to manufacturers of food packaging in evaluating processes for producing packaging from post-consumer recycled plastic. Source: Office of Premarket Approval |
| Frequently Asked Questions about Generally Recognized as Safe (GRAS) (December 2004) Source: Office of Food Additive Safety |
| How to Submit a GRAS Notice (April 17, 1997) |
| Recommendations for Submission of Chemical and Technological Data for Direct Food Additive and GRAS Food Ingredient Petitions (May 1993) Describes the types of chemistry data necessary for supporting petitions for regulations of direct food additives such as synthetic sweeteners, and preservatives; or the affirmation of the use of food ingredients as generally recognized as safe (GRAS) such as sucrose, and many enzymes used in food processing. Source: Office of Premarket Approval |
| Statement of Policy: Foods Derived from New Plant Varieties: Notice (May 1992) FEDERAL REGISTER notice dated May 29, 1992; 57 FR 22984. Source: Office of Premarket Approval |
| Guidelines for the Preparation of Petition Submissions (1996) Source: Office of Premarket Approval |
| Pre-petition Consultations for Food Additives and Color Additives (April 2005) |
| Guidelines for Approval of Color Additives in Contact Lenses Intended as Colors (1996) Source: Office of Premarket Approval |
| FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs or Cosmetics Use (January 1997) Source: Office of Premarket Approval |
| Estimating Exposure to Direct Food Additive and Chemical Contaminants in the Diet (September 1995) Source: Office of Premarket Approval |
| Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food (also known as Redbook I) (1982) Source: National Technical Information Service (NTIS) |
| Toxicological Principles for the Safety of Food Ingredients (Redbook 2000) (July 7, 2000; Updated October 2001, November 2003, January 2006) The Agency is in the process of updating the Redbook and is now making Redbook 2000 chapters available electronically. The Redbook 2000 chapters now substitute for, or supplement, guidance available in the 1982 Redbook I (see above) and in the 1993 Draft Redbook II, which can be obtained from the Office of Food Additive Safety. As additional chapters of Redbook 2000 are completed they will become available electronically. |
| Toxicological Testing of Food Additives (1983) Source: Office of Premarket Approval |
| Templates for Reporting Toxicology Data (March 2004) |
| Draft Guidance: Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition (September 17, 2003) |
| Environmental Assessment Technical Handbook (March, 1987) Order No. PB87175345-AS, A-01 Source: National Technical Information Service (NTIS) |
| Guidance on Consultation Procedures Foods Derived From New Plant Varieties (October 1997) Source: Office of Premarket Approval |
| Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use (November 2004) |
| Bovine Spongiform Encephalopathy (BSE) in Products for Human Use (1997) Executive Secretariat (HF-40) Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 |
| Food Additive Petition Expedited Review—Guidance for Industry and Center for Food Safety and Applied Nutrition Staff (January 1999) Source: Office of Premarket Approval |
| Antimicrobial Food Additives—Guidance (July 1999) Source: Office of Premarket Approval |
| Preparation of Premarket Notifications for Food Contact Substances (Food Contact Notifications (FCN)): Administrative Recommendations (May 2002) |
| Preparation of Food Contact Notifications and Food Additive Petitions for Food Contact Substances: Chemistry Recommendations (April 2002) Source: Office of Food Additive Safety |
| Preparation of Premarket Notifications for Food Contact Substances: Toxicology Recommendations (April 2002) Source: Office of Food Additive Safety |
| Food Labeling Publications |
| A Food Labeling Guide (May 1997) Booklet. This booklet is a summary of the required statements that must appear on food labels. Source: Industry Activities Staff |
| Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims; Small Entity Compliance Guide (August 20, 2003) |
| Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006 (December 30, 2005) |
| Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements (July 10, 2003) |
| Interim Evidence-based Ranking System for Scientific Data (July 10, 2003) |
| Qualified Health Claims in the Labeling of Conventional Foods and Dietary Supplements (December 18, 2002) |
| Draft Guidance: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering (January 2001) |
| Small Business Food Labeling Exemption (June 1996) Information sheet and sample small business exemption application form. Source: Industry Activities Staff |
| Food Labeling: Questions and Answers Volume I, (August 1994) Booklet. Provided to facilitate the advice to retail businesses process of developing or revising labels for foods other than dietary supplements. Source: Industry Activities Staff |
| Food Labeling: Questions and Answers Volume II, (February 1996) Booklet. Contains FDA's advice to retail businesses and restaurants making health and nutrient claims on their food products. Source: Government Printing Office |
| Fair Packaging and Labeling Act Manual (June, 1978) Book. Presents FDA's interpretations of the requirements of the Fair Packaging and Labeling Act as it applies to foods, drugs, cosmetics, and medical devices. Order No. PB-83-222117 Source: National Technical Information Service |
| Implementation of Section 10809 of the Farm Security and Investment Act of 2002, Pub. L. No. 107-171, § 10809 (2002) regarding the Petition Process to Request Approval of Labeling for Foods that Have Been Treated by Irradiation. (available in PDF) |
| Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements (December 1999) Source: Office of Nutritional Products, Labeling & Dietary Supplements |
| Iron-Containing Supplements and Drugs: Label Warning Statements: Small Entity Compliance Guide (October 17, 2003) |
| Structure/Function Claims: Small Entity Compliance Guide (January 9, 2002) |
| Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body (July 1998) Source: Office of Food Labeling |
| FDA Nutrition Labeling Manual—A Guide for Developing and Using Data Bases (March 1998) Source: Office of Food Labeling |
| Guidelines for Determining Metric Equivalents of Household Measures (October 1, 1993) Source: Office of Food Labeling |
| Food Labeling—Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of Shell Eggs Held for Retail Distribution Small Entity Compliance Guide (July 2001) |
| Exemptions from the Warning Label Requirement for Juice—Recommendations for Effectively Achieving a 5-Log Pathogen Reduction (October 7, 2002) |
| Food Labeling—Serving Sizes Reference Amount for Baking Powder, Baking Soda, Pectin; Small Entity Compliance Guide (July 2001) |
| Whole Grain Label Statements (February 2006) |
| Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 2) (December 14, 2005) |
| Food Processing Publications |
| Bacteriological Analytical Manual 7th Edition (1992) Manual. Provides quantitative and qualitative bacteriological testing procedures for detecting microbiological contamination. Contains screening procedures for Salmonella, Shigella, Clostridium botulinum, etc. Source: AOAC International |
| Bacteriological Analytical Manual Online (2001) |
| Food and Cosmetic Security Publications |
| Entry Types and Entry Identifiers—Prior Notice of Imported Food (April 7, 2005) |
| Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (November 16, 2005) |
| Questions and Answers Regarding Establishment and Maintenance of Records (Edition 2) (November 10, 2005) |
| What You Need to Know About Establishment and Maintenance of Records (December 2004) |
| What You Need to Know About Administrative Detention of Foods (November 2004) |
| Prior Notice of Imported Food Contingency Plan for System Outages (August 12, 2004) |
| Questions and Answers Regarding Registration of Food Facilities (Edition 4) (August 6, 2004) |
| Prior Notice of Imported Food Questions and Answers (Edition 2) (May 3, 2004) |
| Cosmetics Processors and Transporters: Cosmetics Security Preventive Measures Guidance (December 17, 2003) |
| Retail Food Stores and Food Service Establishments: Food Security Preventive Measures Guidance (December 17, 2003) |
| What You Need to Know About Registration of Food Facilities (November 25, 2003) |
| What You Need to Know About Prior Notice of Imported Food Shipments (November 25, 2003) |
| Necessity of the Use of Food Product Categories in Registration of Food Facilities (July 17, 2003) |
| Dairy Farms, Bulk Milk Transporters, Bulk Milk Transfer Stations and Fluid Milk Processors Food Security Preventive Measures Guidance (July 11, 2003) |
| Food Producers, Processors, and Transporters: Food Security Preventive Measures Guidance (March 21, 2003) |
| Importers and Filers: Food Security Preventive Measures Guidance (March 21, 2003) |
| See also: Compliance Policy Guides—Guidance for FDA Staff on enforcement of Registration of Food Facilities December 2003, Last Revised November 2004 and Prior Notice of Imported Foods December 2003, Last Revised November 2005 |
| Imports and Exports Publications |
| Prior Notice of Imported Food: Harmonized Tariff Schedule Codes Flagged with Prior Notice Indicators (August 26, 2004)   HTS Codes   Revision History |
| Prior Notice of Imported Food Contingency Plan for System Outages (August 12, 2004) |
| Prior Notice of Imported Food Questions and Answers (Edition 2) (May 3, 2004) |
| What You Need to Know About Prior Notice of Imported Food Shipments (November 25, 2003) |
| Guidance for Industry and FDA: Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors with Interest in Exporting to Chile (June 22, 2005) |
| Importers and Filers: Food Security Preventive Measures Guidance (March 21, 2003) |
| Guidance for Industry: FDA Export Certificates (2002) (also available in PDF) |
| Draft Guidance: Regulatory Procedures Manual Chapter 9, Subchapter: Guidance Concerning Recommending Customs' Seizure and Destruction of Imported Human and Animal Food That Has Not Been Reconditioned (November 5, 2002) |
| Guidance for Industry: Letter to Manufacturers, Importers, and Distributors of Imported Candy and Candy Wrappers (June 13, 1995) |
| FDA Food Importer's Guide for Low-Acid Canned and Acidified Foods (1985) Booklet. Question-and-Answer guide for importers, low-acid and acidified import requirements. Source: Industry Activities Staff |
| See also: Compliance Policy Guides—Guidance for FDA Staff on Guidance Levels for Radionuclides in Domestic and Imported Foods July 2004 |
| Infant Formula Publications |
| Frequently Asked Questions about FDA's Regulation of Infant Formula (March 1, 2006) |
| Guidelines Concerning Notification and Testing of Infant Formula (1985)Source: Office of Nutritional Products, Labeling & Dietary Supplements |
| Guidelines for Evaluation of the Safety and Suitability of New Infant Formulas for Feeding Preterm Infants (1988) Source: Office of Nutritional Products, Labeling & Dietary Supplements |
| Clinical Testing of Infant Formulas with Respect to Nutritional Suitability for Term Infants (1988) Source: Office of Nutritional Products, Labeling & Dietary Supplements |
| Guidelines for Evaluation of the Safety and Suitability of Infant Formulas for Feeding Infants with Allergic Diseases (1990) Source: Office of Nutritional Products, Labeling & Dietary Supplements |
| Guidelines for the Clinical Evaluation of New Products Used in the Dietary Management of Infants, Children and Pregnant Women with Metabolic Disorders (1987) Source: Office of Nutritional Products, Labeling & Dietary Supplements |
| Juice Publications |
| Letter to State Regulatory Agencies and Firms That Produce Treated (but not Pasteurized) and Untreated Juice and Cider (September 22, 2005) |
| Recommendations to Processors of Apple Juice or Cider on the Use of Ozone for Pathogen Reduction Purposes (November 2004) |
| Juice HACCP Hazards and Control Guidance—First Edition (March 3, 2004) |
| The Juice HACCP Regulation: Questions and Answers (September 4, 2003) |
| Standardized Training Curriculum for Application of HACCP Principles to Juice Processing (June 2003) |
| Bulk Transport of Juice Concentrates and Certain Shelf Stable Juices (April 24, 2002) |
| Juice HACCP Small Entity Compliance Guide (April 4, 2003) |
| Exemptions from the Warning Label Requirement for Juice—Recommendations for Effectively Achieving a 5-Log Pathogen Reduction (October 7, 2002) |
| Apple Juice, Apple Juice Concentrates, and Apple Juice Products—Adulteration with Patulin (October 2001) |
| The Juice HACCP Regulation: Questions & Answers (August 31, 2001) |
| Warning and Notice Statement: Labeling of Juice Products Small Entity Compliance Guide (September 18, 1998) |
| Low-Acid and Acidified Foods Publications |
| FDA Food Importer's Guide for Low-Acid Canned and Acidified Foods (1985) Booklet. Question-and-Answer guide for importers, low-acid and acidified import requirements. Source: Industry Activities Staff |
| Milk Sanitation Publications |
| Grade “A” Pasteurized Milk Ordinance 2003 Revision (March 2, 2004) |
| Grade “A” Pasteurized Milk Ordinance 2001 Revision (May 15, 2002) |
| Importation of PMO Defined Dairy Products (M-I-00-4) (April 11, 2000) |
| Evaluation of Milk Laboratories (1995 Edition) Provides the procedures for the evaluation of milk laboratories. Source: Milk Safety Branch |
| Methods of Making Sanitation Ratings of Milk Supplies (1999) Rating method for evaluating sanitary quality of milk. Source: Milk Safety Branch |
| Procedures Governing the Cooperative State-Public Health Service/Food and Drug Administration Program for Certification of Interstate Milk Shippers (1999) Provides procedures for a national reciprocity milk program. Includes by-laws and constitution of the National Conference on Interstate Milk Shipments and the Memorandum of Understanding between the National Conference and FDA. Source: Milk Safety Branch |
| Frozen Dessert Processing Guidelines (1989) Sanitation Standards. Source: Milk Safety Branch |
| Dry Milk Ordinance (1995) Source: Milk Safety Branch |
| Pasteurized Milk Ordinance (1999) Source: Milk Safety Branch |
| Natural Toxins Publications |
| Apple Juice, Apple Juice Concentrates, and Apple Juice Products—Adulteration with Patulin (October 2001) |
| Fumonisin Levels in Human Foods and Animal Feeds (November 9, 2001) |
| Nutrition and Food Science Publications |
| FDA Nutrition Labeling Manual—A Guide for Developing and Using Data Bases (March 1998) Generic instructions for developing and preparing an acceptable data base when valid estimates of nutrient content and variation are not available for the food (single or mixed products) to be labeled. Source: Office of Food Labeling |
| Guidelines for Determining Metric Equivalents of Household Measures (October 1, 1993) Source: Office of Food Labeling |
| List of Products for Each Product Category (October 8, 1992) Source: Office of Food Labeling |
| Label Declaration of Allergenic Substances in Foods; Notice to Manufacturers (June 10, 1996) Source: Office of Food Labeling |
| Guidance on Labeling of Foods that Need Refrigeration by Consumers (February 24, 1997) 62 FR 8248 Source: Office of Food Labeling |
| Interim Guidance on the Voluntary Labeling of Milk and Milk Products that have not been treated with Recombinant Bovine Somatropin (February 10, 1994) 59 FR 6279 Source: Office of Food Labeling |
| Produce Publications |
| Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables (October 26, 1998) (Also available in French, Spanish, Portuguese and Arabic) Source: Food Safety Initiative Staff |
| Draft Guidance: Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables (March 1, 2006) |
| Reducing Microbial Food Safety Hazards For Sprouted Seeds (October 1999) Source: Office of Plant and Dairy Foods and Beverages |
| Sampling And Microbial Testing Of Spent Irrigation Water During Sprout Production (October 1999) Source: Office of Plant and Dairy Foods and Beverages |
| Retail Food Protection Publications |
| A Notice from the Food and Drug Administration to Growers, Food Manufacturers, Food Warehouse Managers, and Transporters of Food Products on Decontamination of Transport Vehicles (October 7, 2005) |
| Retail Food Stores and Food Service Establishments: Food Security Preventive Measures Guidance (December 17, 2003) |
| Food Labeling—Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of Shell Eggs Held for Retail Distribution Small Entity Compliance Guide (July 2001) |
| Sanitation Publications |
| Foods—Adulteration Involving Hard or Sharp Foreign Objects (February 1999) Compliance Policy Guide Chapter 5 Subchapter 555 Section 555.425 |
| Defect Action Levels (DALS) (1995; Revised March 1997 and May 1998) Booklet. This list is compiled from FDA's Compliance Policy Guides on established “current levels for natural or unavoidable defects in food for human use that present no health hazards.” Source: Industry Activities Staff |
| Action Levels for Poisonous or Deleterious Substances in Human Food and Feed (2000) Source: Industry Activities Staff |
| Seafood Publications |
| Refusal of Inspection or Access to HACCP Records Pertaining to the Safe and Sanitary Processing of Fish and Fishery Products (July 2001) Source: Office of Seafood |
| Seafood HACCP Transition Policy (December 1999) Source: Office of Seafood Seafood List (1993) Booklet. FDA's guide to acceptable market names for seafood sold in the interstate commerce. |
| Fish and Fisheries Products Hazards and Control Guide 3rd Edition (2001) Source: Office of Seafood |
| HACCP Regulation for Fish and Fishery Products: Questions and Answers (1998) Source: Office of Seafood |
| Certification of Fish and Fishery Products for Export to the European Union and European Free Trade Association (November 2004) |
| Proposed Referral Program from the Food and Drug Administration to the National Oceanic and Atmospheric Administration Seafood Inspection Program for the Certification of Live and Perishable Fish and Fishery Products for Export to the European Union and the European Free Trade Association (November 2004) |
| Implementation of Section 403(t) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(t)) Regarding the Use of the Term “Catfish” (December 2002) |
| Letter to Various Seafood Trade Associations Regarding the Labeling of Catfish (February 28, 2003) |
| Small Entity Compliance Guides Publications |
| What You Need to Know About Establishment and Maintenance of Records (December 2004) |
| What You Need to Know About Registration of Food Facilities (November 25, 2003) |
| What You Need to Know About Prior Notice of Imported Food Shipments (November 25, 2003) |
| Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims; Small Entity Compliance Guide (August 20, 2003) |
| Juice HACCP Small Entity Compliance Guide (April 4, 2003) |
| Structure/Function Claims: Small Entity Compliance Guide (January 9, 2002) |
| Food Labeling—Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of Shell Eggs Held for Retail Distribution Small Entity Compliance Guide (July 2001) |
| Food Labeling—Serving Sizes Reference Amount for Baking Powder, Baking Soda, Pectin; Small Entity Compliance Guide (July 2001) |
| Statement of Identity, Nutrition Labeling, and Ingredient Labeling of Dietary Supplements Small Entity Compliance Guide (January 1999) Source: Industry Activities Staff |
| Iron-Containing Supplements and Drugs: Label Warning Statements: Small Entity Compliance Guide (October 17, 2003) |

**VI.   Center for Veterinary Medicine (CVM)**

For information on a specific guidance document or to obtain a hard copy, contact: Communications Staff, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301-827-3800, *http://www.fda.gov/cvm/guidance/published.htm* .

The following is a list of CVM guidance documents that have been withdrawn from January 5, 2005, to January 5, 2006.

| Title of Document | Date of Issuance | Date of Withdrawal |
| --- | --- | --- |
| #78 Consideration of the Human Health Impact of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing Animals | 12/1999 | 1/2006 |

The following is a copy of a list of current CVM guidance documents obtained from the FDA Web site as of March 14, 2006.

|  |
| --- |
| 1. Anticoccidial Guidelines replaced by Guideline #40 |
| 2. Anthelmintics Withdrawn 12/22/2004 |
| 3. General Principles for Evaluating the Safety of  Compounds Used in Food-Producing Animals  06/21/05 |
| 4. Guidelines for Efficacy Studies for Systemic Sustained  Release Sulfonamide Boluses for Cattle Withdrawn  12/22/2004 |
| 5. Stability Guidelines 12/90 |
| 6. Guidelines for Submitting NADA's for Generic Drugs  Reviewed by NAS/NRC 10/20/71; rev. 03/19/76 |
| 8. Guidelines for Toxicological Investigations replaced  by Guideline number 3 |
| 9. Preclearance Guidelines for Production Drugs Withdrawn  pending revisions |
| 10. Amendment of Section II(G)(1)(b)(4) of the  Preclearance Guidelines 10/75 |
| 13. Guidelines for Evaluation of Effectiveness of New  Animal Drugs for Use in Free-Choice Feeds revision of  Medicated Block 01/85 |
| 14. Guideline and Format for Reporting the Details of  Clinical Trials Using An Investigational New Animal Drug  in Food Producing Animals Withdrawn 12/22/2004 |
| 15. Guideline and Format for Reporting the Details of  Clinical Trials Using An Investigational New Animal Drug  in Non-Food Producing Animals (2277) Withdrawn 12/22/2004 |
| 16. FOI Summary Guideline 05/85 |
| 17. Working Guidelines for Assigning Residue Tolerances  replaced by Guideline # 3 |
| 18. Antibacterial Drugs in Animal Feeds: Human Health  Safety Criteria Withdrawn 12/22/2004 |
| 19. Antibacterial Drugs in Animal Feeds: Animal Health  Safety Criteria Withdrawn 12/22/2004 |
| 20. Antibacterial Drugs in Animal Feeds: Antibacterial  Effectiveness Criteria Withdrawn 12/22/2004 |
| 21. Nutritional Ingredients in Animal Drugs and Feeds  Nutritional Ingredients in Animal Drugs and Feeds  (see Policy and Procedures Guide 1240.3420) rev. 03/93 |
| 22. Guideline Labeling of Arecoline Base Drugs Intended  for Animal Use |
| 23. Medicated Free Choice Feeds—Manufacturing Control  07/85 |
| 24. Guidelines for Drug Combinations for Use in Animals  10/83 |
| 25. Guidelines for the Efficacy Evaluation of Equine  Anthelmintics Replaced by Guidance 109 |
| 26. Guidelines for the Preparation of Data to Satisfy the  Requirements of Section 512 of the Act Regarding Animal  Safety, Effectiveness, Human Food Safety and  Environmental Considerations for Minor Use of New Animal  Drugs  (superceded by Guidance #61) 04/86; see also Guideline 61, below. |
| 27. New Animal Drug Determinations  (see Policy and Procedures Guide 1240.3500) 07/89 |
| 28. Animal Drug Applications Expedited Review Guideline  (see Policy and Procedures Guide 1240.3135) 06/90 |
| 29. Guidelines for the Effectiveness Evaluation of Swine  Anthelmintics 09/80 |
| 30. Guidelines for Anti-infective Bovine Mastitis Product  Development replaced by guideline #49 |
| 31. Guidelines for the Evaluation of Bovine Anthelmintics  07/81 |
| 32. Guideline for Threshold Assessment replaced by  Guideline number 3 |
| 33. Target Animal Safety Guidelines for New Animal Drugs  06/89 |
| 34. Biomass Guideline—Guideline for New Animal Drugs  and Food Additives Derived From a Fermentation; Human  Food Safety Evaluation replaced by Guideline number 3 |
| 35. Bioequivalence Guideline revised 10/09/02 |
| 36. Guidelines for Efficacy Evaluation of Canine/Feline  Anthelmintics 07/85 |
| 37. Guidelines for Evaluation of Effectiveness of New  Animal Drugs for Use in Poultry Feed for Pigmentation  03/84 |
| 38. Guideline for Effectiveness Evaluation of  Topical/Otic Animal Drugs 03/84 |
| 39. Guideline on the Conduct of Clinical Investigations:  Responsibilities of Clinical Investigators and Monitors  for Investigational New Animal Drug Studies replaced by  Guidance # 85 |
| 40. Draft Guideline for the Evaluation of the Efficacy of  Anticoccidial Drugs and Anticoccidial Drug Combinations  in Poultry 04/92 |
| 41. Draft Guideline: Formatting, Assembling, and  Submitting New Animal Drug Applications 06/92 |
| 42. Series of four guidelines entitled “Animal Drug  Manufacturing Guidelines” 1994 |
| 43. Draft Guideline for Generic Animal Drug Products  Containing Fermentation-Derived Drug Substances 10/95 |
| 45. Guideline for Uniform Labeling of Drugs for Dairy and  Beef Cattle 08/93 |
| 48. Guidance for Industry: Submission Documentation for  Sterilization Process Validation in Applications for  Human and Veterinary Drug Products 11/94 |
| 49. Guidance Document For Target Animal Safety And Drug  Effectiveness Studies For Anti-Microbial Bovine Mastitis  Products (Lactating and Non-Lactating Cow Products) 04/96 |
| 50. Draft Guideline for Target Animal and Human Food  Safety, Drug Efficacy, Environmental and Manufacturing  Studies for Teat Antiseptic Products 02/93 |
| 51. Points to Consider Guideline—Development of a  Pharmacokinetic Guideline Enabling Flexible Labeling of  Therapeutic Antimicrobials “Please see Guidance 66 for  updated information.” |
| 52. Assessment of the Effects of Antimicrobial Drug  Residues from Food of Animal Origin on the Human  Intestinal Flora, February 18, 2004  Replaced by Guidance 159 |
| 53. Guideline for the Evaluation of the Utility of Food  Additives in Diets Fed to Aquatic Animals 05/94 |
| 54. Draft Guideline for Utility Studies for  Anti-Salmonella Chemical Food Additives in Animal Feeds—See Final Guidance #80 06/94 |
| 55. Supportive Data for Cat Food Labels Bearing “Reduces  Urinary pH Claims: Guideline in Protocol Development  06/94 |
| 56. Protocol Development Guideline for Clinical  Effectiveness and Target Animal Safety Trials 07/10/01 |
| 57. Master Files: Guidance for Industry for the  Preparation and Submission of Veterinary Master Files 1995 |
| 58. Guidance for Industry for Good Target Animal Study  Practices: Clinical Investigators and Monitors  Withdrawn 12/22/2004; superceded by guidance #85 |
| 59. Guidance for Industry: How to Submit a Notice of  Claimed Investigational Exemption in Electronic Format  by E-Mail 01/17/06 |
| 60. Guidance For Industry: Animal Proteins Prohibited  From Animal Feed; Small Entity Compliance Guide Replaced  by Guidance 67, 68, 69, and 70 |
| 61. Guidance For Industry: FDA Approval of New Animal  Drugs for Minor Uses and for Minor Species 04/99 |
| 62. Guidance for Industry: Consumer-Directed Broadcast  Advertisements: Final Guidance 08/99 |
| 63. Guidance for Industry: Validation of Analytical  Procedures: Definition and Terminology 07/99 |
| 64. Guidance for Industry: Validation of Analytical  Procedures: Methodology: Final Guidance 07/99 |
| 65. Guidance for Industry: Industry-Supported Scientific  and Educational Activities 11/97 |
| 66. Withdrawal of Guidance Document on Professional  Flexible Labeling of Antimicrobial Drugs 01/02 |
| 67. Guidance for Industry: Small Entities Compliance  Guide for Renderers 02/98 |
| 68. Guidance for Industry: Small Entities Compliance  Guide for Protein Blenders, Feed Manufacturers, and  Distributors 02/98 |
| 68. Guía de la FDA para la Industria Número 68: Para  Mezcladores de Proteínas, Fabricantes de Alimentos para  Animales y Distribuidores 02/09 |
| 69. Guía de la FDA para la Industria Número 69: Para  Alimentadores de Animales Rumiantes con Operaciones de  Mezclado de Alimentos en la Granja 02/98 |
| 69. Guidance for Industry: Small Entities Compliance  Guide for for Feeders of Ruminant Animals with On-Farm  Feed Mixing Operations 02/98 |
| 70. Guidance for Industry: Small Entities Compliance  Guide for Feeders of Ruminant Animals without On-Farm  Feed Mixing Operations 02/98 |
| 70. Guía de la FDA para la Industria Número70: Para  Alimentadores de Animales Rumiantes sin Operaciones de  Mezclado de Alimentos en la Granja 02/98 |
| 71. Guidance for Industry: Use of Human Chorionic  Gonadotropin (HCG) as a Spawning Aid for Fish Rescinded |
| 72. Guidance For Industry: GMP'S For Medicated Feed  Manufacturers Not Required to Register and be Licensed  with FDA 05/98 |
| 73. Guidance For industry: Stability Testing Of New  Veterinary Drug Substances And Medicinal Products VICH  GL3: FINAL GUIDANCE 09/99 |
| 74. Guidance for Industry: Stability Testing of New  Veterinary Dosage Forms VICH GL4: FINAL GUIDANCE 09/99 |
| 75. Guidance For Industry: Stability Testing:  Photostability Testing of New Veterinary Drug Substances  and Medicinal Products: Final GUIDANCE 09/99 |
| 76. Guidance For Industry: Questions and Answers BSE Feed  Regulations 07/98 |
| 77. Guidance for Industry: Interpretation of On-Farm Feed  Manufacturing and Mixing Operations: DRAFT GUIDANCE Withdrawn 06/12/03 |
| 78. Consideration of the Human Health Impact of the  Microbial Effects of Antimicrobial New Animal Drugs  Intended for Use in Food-Producing Animals  Replaced by Guidance 152 |
| 79. Guidance for Industry #79—Dispute Resolution  Procedures for Science-Based Decisions on Products  Regulated by the Center for Veterinary Medicine (CVM)—Final Guidance July 2005 |
| 80. Studies to Evaluate the Utility of Anti-Salmonella  Chemical Food Additives in Feeds 11/21/02 |
| 82. Guidance for Industry: Development of Supplemental  Applications for Approved New Animal Drugs—Final  Guidance 10/28/02 |
| 83. Guidance for Industry: Chemistry, Manufacturing and  Controls Changes to an Approved NADA or ANADA: DRAFT  GUIDANCE 06/99 |
| 84. Guidance for Industry:Product Name Placement, Size,  and Prominence in Advertising and Promotional Labeling:  DRAFT GUIDANCE 03/99 |
| 85. Guidance for Industry: Good Clinical Practices: VICH  GL9, Final Guidance 05/09/01 |
| 86. Guidance for Industry—How to Submit a Notice of  Final Disposition of Investigational Animals Not  Intended for Immediate Slaughter in Electronic Format by  E-Mail 1/17/06 |
| 87. Guidance for Industry—How to Submit a Notice of  Intent to Slaughter for Human Food Purposes in  Electronic Format by E-mail 01/17/06 |
| 88. Guidance for Industry—How to Submit a Request for a  Meeting or Teleconference in Electronic Format by E-mail 01/17/06 |
| 89. Guidance for Industry—Environmental Impact  Assessments (EIA's) For Veterinary Medicinal Products  (VMP's)—Phase I, VICH GL6: Final Guidance 03/07/01 |
| 90. Guidance for Industry—Effectiveness of  Anthelmintics: General Recommendations, Final Guidance—VICH GL7 (replaces 3/26/2001) 10/11/01 |
| 91. Guidance for Industry: International Cooperation on  Harmonisation of Technical Requirements for Approval of  Veterinary Medicinal products (VICH); Final Guidance on  Stability Testing for Medicated Premixes (VICH GL8);  Availability 03/00 |
| 92. Guidance for Industry #92: Impurities In New  Veterinary Drug Substances (Revision), VICH GL10 ( R) ,  Draft Revised Guidance, January 5, 2006 01/05/06 |
| 93. Guidance for Industry #93—Impurities in New  Veterinary Medicinal Products (Revised), Draft Revised  Guidance—VICH GL11 (R), January 10, 2006 01/10/05 |
| 95. Guidance for Industry: Efficacy Of Anthelmintics:  Specific Recommendations for Bovines: VICH GL12, Final  Guidance 03/26/01 |
| 96. Guidance for Industry: Efficacy Of Anthelmintics:  Specific Recommendations for Ovines: VICH GL13, Final  Guidance 03/26/01 |
| 97. Guidance for Industry: Efficacy Of Anthelmintics:  Specific Recommendations for Caprines: VICH GL14, Final  Guidance 03/26/01 |
| 98. Dioxin In Anti-Caking Agents Used In Animal Feed And  Feed Ingredients Revised 04/14/00 |
| 99. Guidance for Industry: Stability Testing of New  Biotechnological/Biological Veterinary Medicinal  Products—VICH GL17—Final Guidance 03/26/01 |
| 100. Guidance for Industry: Impurities: Residual Solvents  in New Veterinary Medicinal Products, Active Substances  and Excipients: VICH GL18, Final Guidance 05/15/01 |
| 102. Guidance for Industry: “Manufacture and Distribution  of Unapproved Piperazine Products”—Revised 08/99 |
| 103. Guidance for Industry: Possible Dioxin/PCB  Contamination of Drug and Biological Products 08/99 |
| 104. Guidance for Industry: Content and Format of  Effectiveness and Target Animal Safety Technical  Sections and Final Study Reports For Submission to the  Division of Therapeutic Drugs for Non-Food Animals 07/10/01 |
| 105. Draft Guidance for Industry: Computerized Systems  Used in Clinical Trials, Revision 1, Erratum, September  2004 09/04 |
| 106. The Use of Published Literature in Support of New  Animal Drug Approval 08/31/00 |
| 107. Guidance for Industry: How to Submit a Protocol in  Electronic Format by E-Mail 01/17/06 |
| 108. Guidance for Industry: How to Submit Information in  Electronic Format by E-Mail 01/17/06 |
| 109. Guidance for Industry #109: Effectiveness of  Anthelmintics: Specific Recommendations for Equine—VICH GL15—Final Guidance 06/27/02 |
| 110. Guidance for Industry #110: Effectiveness of  Anthelmintics: Specific Recommendations for Porcine—VICH GL16—Final Guidance 06/27/02 |
| 111. Guidance for Industry #111: Effectiveness of  Anthelmintics: Specific Recommendations for Canine—VICH GL19—Final Guidance 06/27/02 |
| 112. Guidance For Industry 112 : Fumonisin Levels in  Human Foods and Animal Feeds—Final Guidance 11/09/01 |
| 113. Guidance for Industry: Effectiveness of  Anthelmintics: Specific Recommendations for Feline—VICH GL20—Final Guidance 06/19/02 |
| 114. Guidance for Industry: Effectiveness of  Anthelmintics: Specific Recommendations for  Poultry-Gallus Gallus—VICH GL21—Final Guidance 06/19/02 |
| 115. Guidance for Industry: Safety Studies for Veterinary  Drug Residues in Human Food: Reproduction Studies—VICH  GL22—Final Guidance 01/03/02 |
| 116. Guidance for Industry: Studies to Evaluate the  Safety of Residues of Veterinary Drugs in Human Food:  Genotoxicity Testing—VICH GL23—Final Guidance 01/03/02 |
| 117. Guidance for Industry: Pharmacovigilance of  Veterinary Medicinal Products: Management of Adverse  Event Reports (AER's)—VICH GL24—DRAFT GUIDANCE 12/12/00 |
| 118. Guidance for Industry: Mass Spectrometry for  Confirmation of the Identity of Animal Drug Residues—Final Guidance 05/01/03 |
| 119. Guidance for Industry and Reviewers: How the Center  for Veterinary Medicine Intends to Handle Deficient  Submissions Filed During the Investigation of a New  Animal Drug—Final Guidance 08/29/02 |
| 120. Guidance for Industry #120—Veterinary Feed  Directive Regulation 03/01/01 |
| 121. Guidance for Industry #121: Expedited Review for New  Animal Drug Applications for Human Pathogen Reduction  Claims 03/06/01 |
| 122. Guidance for Industry: Manufacture and Labeling of  Raw Meat Foods for Companion and Captive Noncompanion  Carnivores and Omnivores, May 18, 2004 Revised 11/09/04 |
| 123. Guidance for Industry 123—Development of Target  Animal Safety and Effectiveness Data to Support Approval  of Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) for  Use in Animals, Final, January 5, 2006 01/05/06 |
| 124. Guidance for Industry # 124: Voluntary Labeling  Indicating Whether Foods Have or Have Not Been Developed  Using Bioengineering—Draft 01/17/01 |
| 126. Guidance for Industry #126—BACPAC I: Intermediates  in Drug Substance Synthesis Bulk Actives Postapproval  Changes: Chemistry, Manufacturing, and Controls  Documentation, February 2001 02/01 |
| 132. Guidance for Industry: The Administrative New Animal  Drug Application Process—Draft 11/06/02 |
| 135. Guidance for Industry: Validation of Analytical  Procedures for Type C Medicated Feeds, Final 11/07/05 |
| 141. Guidance for Industry: Studies to Evaluate the  Safety of Residues of Veterinary Drugs in Human Food:  Carcinogenicity Testing, VICH GL28, Final Guidance 05/24/04 |
| 142. CVM Guidance for Industry #142: Pharmacovigilance of  Veterinary Medicinal Products: Management of Periodic  Summary Update Reports (PSUs)—VICH GL29—Draft  Guidance 12/12/01 |
| 143. CVM Guidance for Industry #143: Pharmacovigilance of  Veterinary Medicinal Products: Controlled List of Terms—VICH GL30—Draft Guidance 02/01/02 |
| 144. Guidance for Industry: Pre-Approval Information for  Registration of New Veterinary Medicinal Products for  Food-Producing Animals with Respect to Antimicrobial  Resistance—VICH GL27, Final Guidance 04/27/04 |
| 145. Bioanalytical Method Validation 05/01 |
| 147. Guidance for Industry 147—Studies to Evaluate the  Safety of Residues of Veterinary Drugs in Human Food:  Repeat-Dose (90-Day) Toxicity Testing—VICH GL31, 11/12/03 |
| 148. Guidance for Industry: Studies to Evaluate the  Safety of Residues of Veterinary Drugs in Human Food:  Developmental Toxicity Testing—VICH GL32 Final  Guidance 03/19/04 |
| 149. Guidance for Industry: Studies to Evaluate the  Safety of Residues of Veterinary Drugs in Human Food:  General Approach to Testing VICH GL33 05/18/04 |
| 150. Guidance for Industry: Status of Clove Oil and  Eugenol for Anesthesia of Fish 06/11/02 |
| 151. Guidance for Industry: FDA Export Certificates 07/04 |
| 152. Guidance for Industry: Evaluating the Safety of  Antimicrobial New Animal Drugs with Regard to Their  Microbiological Effects on Bacteria of Human Health  Concern 10/23/03 |
| 153. Draft Guidance for Industry: Drugs, Biologics, and  Medical Devices Derived From Bioengineered Plants for  Use in Humans and Animals 09/02 |
| 154. Draft Guidance for Industry: 21 CFR Part 11;  Electronic Records; Electronic Signatures, Maintenance  of Electronic Records Withdrawn 02/25/03 |
| 155. Draft Guidance for Industry: 21 CFR Part 11:  Electronic Records; Electronic Signatures; Electronic  Copies of Electronic Records Withdrawn 02/04/03 |
| 156. Draft Guidance for Industry: Comparability  Protocols—Chemistry, Manufacturing, and Controls  Information; Availability 02/03 |
| 157. Guidance for Industry: Part 11, Electronic Records,  Electronic Signatures—Scope and Application 08/03 |
| 158. Guidance for Industry—Use of Material from Deer  and Elk in Animal Feed 09/15/03 |
| 159. Guidance for Industry: Studies to Evaluate the  Safety of Residues of Veterinary Drugs in Human Food:  General Approach to Establish a Microbiological ADI—VICH GL-36, Final Guidance 02/10/05 |
| 160. Guidance for Industry—Studies to Evaluate the  Safety of Residues of Veterinary Drugs in Human Food:  Repeat-Dose (Chronic) Toxicity Testing, VICH GL-37—Final Guidance 02/07/05 |
| 162. Draft Guidance for Industry—Comparability  Protocols—Protein Drug Products and Biological  Products—Chemistry, Manufacturing, and Controls  Information 09/03 |
| 163. Draft Guidance for Industry : Formal Dispute  Resolution: Scientific and Technical Issues Related to  Pharmaceutical CGMP 08/03 |
| 164. Guidance for Industry—PAT—A Framework for  Innovative Pharmaceutical Development, Manufacturing,  and Quality Assurance, September 2004 09/04 |
| 165. Draft Guidance for Industry: Providing Regulatory  Submissions in Electronic Format—General Considerations 10/03 |
| 166. Guidance for Industry—Environmental Impact  Assessments (EIA's) for Veterinary Medicinal Products  (VMPs), Phase II, Final Guidance, VICH GL38, 01/09/06 |
| 167. Guidance for Industry: Prior Notice of Imported Food  Questions and Answers 12/12/03 |
| 168. Guidance to Industry: Prior Notice of Imported Food:  Harmonized Tariff Schedule Codes Flagged with Prior  Notice Indicators 11/20/03 |
| 169. Guidance for Industry: Drug Substance: Chemistry,  Manufacturing, and Controls Information, Draft Guidance 01/04 |
| 170. Guidance for Industry: Animal Drug User Fees and Fee  Waivers and Reductions, Final Guidance, March 15, 2004 03/15/04 |
| 171. Guidance for Industry on Waivers of In Vivo  Demonstration of Bioequivalence of Animal Drugs in  Soluble Powder Oral Dosage Form Products and Type A  Medicated Articles; Availability (Notice) 02/16/06 |
| 172. Guidance for Industry #172—Use of unapproved  hormone implants in veal calves, April 2, 2004  Withdrawn 07/15/04 |
| 173. Guidance for Industry—Animal Drug Sponsor Fees  Under the Animal Drug User Fee Act (ADUFA) Appendix 02/07/05 |
| 174. Guidance for Industry—Use of Material from BSE  Positive Cattle in Animal Feed 09/30/04 |
| 176. Guidance for Industry #176—Specifications: Test  Procedures and Acceptance Criteria for New Veterinary  Drug Substances and New Medicinal Products: Chemical  Substances—VICH GL-39, Draft Guidance—May 24, 2005 05/24/05 |
| 177. Guidance for Industry #177—Specifications: Test  Procedures and Acceptance Criteria for New  Biotechnological/Biological Veterinary Medicinal  Products—VICH GL-40, Draft Guidance—May 24, 2005 05/24/05 |

**VII.   Office of the Commissioner/Office of Policy (OC/OP)**

For information on a specific guidance document or to obtain a hard copy, contact:

For guidance documents pertaining to Good Clinical Practices: Good Clinical Practices Program, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3340, *http:///www.fda.gov/oc/gcp/guidance.html* .

For other guidance documents listed under OC/OP: Office of Policy, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3360, *http://www.fda.gov/opacom/morechoices/industry/guidedc.html* .

No OC/OP guidance documents were withdrawn from January 5, 2005, to January 5, 2006.

The following is a copy of a list of current OC/OP guidance documents obtained from the FDA Web site as of March 14, 2006.

|  |
| --- |
| Office of the Commissioner: |
| Draft Guidance: Using Electronic Means to Distribute Certain Product Information |
| Draft Guidance; Emergency Use Authorization of Medical Products |
| Conflict of Interest Disclosure Guidance |
| Small Business Guide to FDA |
| FDA Guidance—Financial Disclosure by Clinical Investigators, March 20, 2001 |
| FDA Guidance for Industry on: Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996 (Federal Register June 12, 1998) |
| Guidance for FDA and Industry: Direct Final Rule Procedures (Federal Register Nov. 21, 1997) |
| Final Guidance on Industry-Supported Scientific and Educational Activities (Federal Register Dec. 3, 1997) |
| Guidances and Information Sheets on Good Clinical Practice in FDA-Regulated Clinical Trials |
| Guidances |
| FDA Information Sheet Guidances for Institutional Review Boards, Clinical Investigators, and Sponsors |
| Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection |
| Guidance for Industry: Acceptance of Foreign Clinical Studies |
| Guidance for Industry: Available Therapy |
| Guidance for Industry: Computerized Systems Used in Clinical Trials |
| Guidance for Industry: Development and Use of Risk Minimization Action Plans |
| Guidance for Industry Exploratory IND Studies |
| Guidance for Industry: Financial Disclosure by Clinical Investigators |
| Guidance for Industry: Food-Effect Bioavailability and Fed Bioequivalence Studies |
| Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment |
| Guidance for Industry: Guideline for the Monitoring of Clinical Investigators |
| Guidance for Industry: Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs |
| Guidance for Industry on Handling and Retention of Bioavailability and Bioequivalence Testing Samples; Availability |
| Guidance for Industry: IND Exemptions for Studies of Lawfully Marketed Drug or Biologicial Products for the Treatment of Cancer |
| Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions |
| Guidance for Industry: IRB Review of Stand-Alone HIPAA Authorizations Under FDA Regulations |
| Guidance for Industry on Part 11, Electronic Records; Electronic Signatures—Scope and Application |
| Guidance on Pharmacogenomic Data Submissions |
| Guidance for Premarketing Risk Assessment |
| Guidance for Industry: Providing Regulatory Submissions in Electronic Format—Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications |
| Guidance for Industry and Clinical Investigators on the Use of Clinical Holds Following Clinical Investigator Misconduct |
| ICH Guidances |
| ICH E3: Guideline for Industry Structure and Content of Clinical Study Reports |
| ICH E5: Ethnic Factors in the Acceptability of Foreign Clinical Data |
| ICH E6: Good Clinical Practice: Consolidated Guidance |
| ICH E10: Choice of Control Group and Related Issues in Clinical Trials |

**VIII.  Office of Regulatory Affairs (ORA)**

For information on a specific guidance document or to obtain a hard copy, contact: Office of Executive Operations, Office of Regulatory Affairs, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, *http://www.fda.gov/ora* .

The following is a list of ORA guidance documents that have been withdrawn from January 5, 2005, to January 5, 2006.

| Title of Document | Date of Issuance | Date of Withdrawal |
| --- | --- | --- |
| CPG—Sec. 160.800 Year 2000 (Y2K) Computer Compliance (CPG 7153.15) | April 26, 1999 | March 8, 2005 |
| CPG—Sec. 355.100 Cellutron Machine (CPG 7124.03) | May 31, 1990 | March 10, 2005 |
| CPG—Sec. 460.700 Controlled Release Dosage Form Drugs—Rate of Release of Active Ingredients (CPG 7132a.02) | January 1, 1973 | August 19, 2005 |

The following is a copy of a list of current ORA guidance documents obtained from the FDA Web site as of March 14, 2006.

|  |
| --- |
| Industry Assistance Reference |
| FDA contact sources for industry assistance and inquiries. |
| Medical Devices—Division of Small Manufacturers , International and Consumer Assistance (DSMICA) |
| Quality Systems/Good Manufacturing Practices Survey/Report |
| FDA Small Business Program Office |
| Regional Small Business Representatives |
| A Small Business Guide to FDA |
| FDA Industry focus page |
| Code of Federal Regulations |
| FDA Public Workshops |
| ORA Science Reference |
| Information related to the locations of the components, ORA laboratory, laboratory procedures, new techniques and useful analytical findings in support of FDA regulatory activities. ORA Science References are available for the following: |
| TOTAL DIET AND PESTICIDE RESEARCH CENTER—Information and materials relating to the FDA Total Diet Study Research. |
| LABORATORY MANUAL 2004—Agency policy for testing consumer products, training of laboratory staff, report writing, safety, research, review of private laboratory reports and court testimony. (Formerly: Laboratory Procedure Manual) |
| LABORATORY INFORMATION BULLETINS—Samples of collection of more than 3,000 bulletins describing new techniques and useful analytical findings by ORA laboratories in support of FDA regulatory activities. |
| PRIVATE LABORATORIES—Information concerning private laboratories and activities are included in this section. |
| ORA Compliance Reference |
| Revisions and Update List |
| Recent: |
| 03/08/2006:        Revised list to add 1 new member, Restricted List for Clinical         Investigators |
| 02/09/2006:         Updated the program contact person (s) information on the following         pages:         http://www.fda.gov/ora/compliance_ref/bimo/default.htm         http://www.fda.gov/ora/compliance_ref/bimo/background.html         http://www.fda.gov/ora/compliance_ref/bimo/comparison_chart/preface.html |
| 01/19/2006:        Change in classification (Class)—Pine Acres Research Facility, Norton,         MA |
| 01/11/2006:        Updated list to remove restriction for 1 member. Restricted List for         Clinical Investigators |
| 12/29/2005:        Revised Restricted List for Clinical Investigators to add 1 new member |
| 12/21/2005:        Revised 4 lists of Nonclinical Laboratories Inspected Since Fiscal Year         1990. Updated December 09, 2005        Edited list to correct typographical error in the initial of Dr. Farber         on Disqualified/Totally Restricted List for Clinical Investigators        Updated “FDA AIP Contacts List” (December 2005) on the Application         Integrity Policy Information page |
| 12/12/2005:        Revised CPG Sec. 230.150—Blood Donor Classification Statement, Paid or         Volunteer Donor         Revised CPG Sec. 300.750—Class III Devices Subject to 515(b)         Requirements (CPG 7124.18)        Revoked CPG Sec. 460.700—Controlled Release Dosage Form Drugs—Rate         of Release of Active Ingredients (CPG 7132a.02) |
| 12/06/2005:        Updated list to remove restriction for 1 member, 11/23/2005: Restricted         List for Clinical Investigators |
| 12/01/2005:        Updated “FDA AIP Contacts List” (August 2005) on the Application         Integrity Policy Information page |
| 11/29/2005:        Edited Compliance Policy Guides Sec. 160.100 and 118 pages in Chapter 5         to reflect FDA organization and contact changes. |
| 11/18/2005:        Added on-line link for compliance program 7385.014, Mammography Facility         Inspections.        Revised list to add 1 new member on Disqualified/Totally Restricted List         for Clinical Investigators |
| 11/14/2005:         Revised list to add 1 new member, Disqualified/Totally Restricted List         for Clinical Investigators |
| 11/10/2005:        Revised CPG Sec. 110.310—Prior Notice of Imported Food Under the         Public Health Security and Bioterrorism Preparedness and Response Act of         2002 |
| 11/03/2005:         Revised list to remove one member from the Application Integrity Policy         List |
| 10/31/2005:         Revised http://www.fda.gov/ora/compliance_ref/bimo/disqlist.htm to add         one person and update the list contact person. Also, the contact person         was updated on:         http://www.fda.gov/ora/compliance_ref/bimo/asurlist.htm         http://www.fda.gov/ora/compliance_ref/bimo/restlist.htm |
| 09/15/2005:        Revised 4 lists of Nonclinical Laboratories Inspected Since Fiscal Year         1990 Updated September 15, 2005 |
| 09/13/2005:        Revised list to remove one member on the Application Integrity Policy         List |
| 08/08/2005:        Revoked by Federal Register notice on 09/24/1998 (63 FR 51074), CPG Sec.         615.100 Extra-Label Use of New Animal Drugs in Food-Producing Animals         (CPG 7125.06) |
| 08/04/2005:        Updated the program contact person (s) information on the following         pages:         http://www.fda.gov/ora/compliance_ref/bimo/default.htm         http://www.fda.gov/ora/compliance_ref/bimo/background.html         http://www.fda.gov/ora/compliance_ref/bimo/comparison_chart/preface.html         http://www.fda.gov/ora/compliance_ref/bimo/comparison_chart/preface.html         http://www.fda.gov/ora/compliance_ref/bimo/glp/wh_list_intro.htm (and         related GLP lists) |
| 08/02/2005:        Table for Veterinary Medicine compliance programs is updated to reflect         on-line documents and/or information now supplied by the Center for         Veterinary Medicine. |
| 07/28/2005:        Revised Debarment List, 07/28/2005—One person added. |
| 07/18/2005:        Re-numbered existing biologics compliance program 7341.002 “Inspection         of Tissue Establishments” to 7341.002A and added new biologics         compliance program 7341.002 “Inspection of Human Cells, Tissues, and         Cellular and Tissue-based Products (HCT/Ps).” |
| 5/31/2005        Draft revised CPG Sec. 480-200—Expiration Dating of Unit-Dose         Repackaged Drugs (CPG 7132b.11)        Notice of Availability        Draft Guidance |
| 05/20/2005:        Revised list to add 1 new member, Restricted List for Clinical         Investigators |
| 05/19/2005:        Revised CPG Sec. 315.100 Illegal Interstate Commercial Shipment of         Dentures (CPG 7124.07) |
| 05/17/2005:        Revised list to add 1 new member, Restricted List for Clinical         Investigators |
| 05/05/2005:        Added new biologics compliance program 7345.848 Inspection of Biological         Drug Products, and removed four programs that the new program         supersedes: 7341.001, 7342.006, 7345.001, and 7345.002. |
| 04/25/2005        Revised CPG 100.700 GWQAP Pre-Award Evaluation—Inadequate Information         to Evaluate Prospective Supplier |
| 04/25/2005        Revised CPG 390.300 Assessment of Civil Penalties Against Manufacturers         and Importers of Electronic Products |
| 04/18/2005:        Revised 4 lists of Nonclinical Laboratories Inspected Since Fiscal Year         1990 Updated April 18, 2005 |
| 04/13/2005        Revised CPG Sec. 560.400 Imported Milk and Cream—Federal Import Milk         Act CPG 7119.05 |
| 04/12/2005:        Revised Debarment List, 04/12/2005—One person added. |
| 04/11/2005:        Revised list to add 3 new members,        Restricted List for Clinical Investigators |
| 03/23/2005        Revised list to add one new member; and remove one Application Integrity         Policy List |
| 03/18/2005        Revised CPG Sec. 300.500—Reprocessing of Single Use Devices (CPG         7124.16) |
| 03/10/2005        Revised 8 CPGs to make corrections/minor changes: Sec. 390.100; Sec.         390.400; Sec. 393.100; Sec. 396.300; Sec. 398.100; Sec. 398.325; Sec.         398.425; Sec. 398.700; |
| 03/10/2005        Revoked CPG: Sec. 355.100—Cellutron Machine |
| 03/08/2005        Revoked 03/08/2005, Compliance Policy Guide, Sec. 160.800 Y2K Computer         Compliance |
| 03/08/2005:        Revised list to add 2 new members,         Restricted List for Clinical Investigators |
| 03/04/2005:        Revised CPG Sec. 110.310—Prior Notice of Imported Food Under the         Public Health Security and Bioterrorism Preparedness and Response Act of         2002 |
| 02/18/2005:        Draft revised CPG Sec. 310.210 “Blood Pressure Measurement Devices         (Sphygmomanometers)—Accuracy (CPG 7124.23)        FR Notice of Availability   Draft Revision |
| 02/01/2005:        Revised list to add 1 new member,        Restricted List for Clinical Investigators |
| 01/14/2005:        Revised list to add 1 new member,        Disqualified/Totally Restricted List for Clinical Investigators |
| 2004 Revisions and Updates: |
| 12/07/2004         Revised Debarment List, 12/07/2004—One person added. Published         12/02/2004. |
| 11/18/2004        Revised 4 lists of Nonclinical Laboratories Inspected Since Fiscal Year         1990 Updated November 18, 2004 |
| 11/16/2004        New CPG Sec. 400.210—Radiofrequency Identification Feasibility Studies         and Pilot Programs |
| 11/03/2004        Revised CPG Sec. 110.300—Registration of Food Facilities Under the         Public Health Security and Bioterrorism Preparedness and Response Act of         2002 |
| 11/02/2004        Revised CPG Sec. 110.310—Prior Notice of Imported Food Under the         Public Health Security and Bioterrorism Preparedness and Response Act of         2002 |
| 10/29/2004        Draft CPG (Not for Implementation), Sec. 560.400 “Imported Milk and         Cream—Federal Import Milk Act (CPG 7119.05).” When finalized it will         replace the existing CPG at Sec. 560.400. Comments due 30 days after         date of publication in the Federal Register dated October 29, 2004 |
| 10/03/2004        Revised list to add 1 new member, Disqualified/Totally Restricted List         for Clinical Investigators |
| 08/31/2004         Edited Debarment List—at Uddin, Mohammad, added “NMI” to indicate that         FDA records show no middle initial for this person. |
| 08/16/2004        Revised CPG Sec. 110.310—Prior Notice of Imported Food Under the         Public Health Security and Bioterrorism Preparedness and Response Act of         2002 |
| 07/29/2004         Revised CPG Sec. 394.500—Importation of Television Products, Microwave         Ovens, and Inherent Class I Laser Products for Investigation and         Evaluation |
| 07/29/2004        Replaced/Retitled CPG Sec. 560.750 Guidance Levels for Radionuclides in         Domestic and Imported Foods (CPG 7119.14) |
| 07/23/2004         Updated links to FDA Regulations (2004) on the Bioresearch Monitoring         Information Page;        links to laws enforced by FDA and related regulation on the Welcome to         Compliance References page |
| 06/24/2004        Revised CPG Sec. 110.310—Prior Notice of Imported Food Under the         Public Health Security and Bioterrorism Preparedness and Response Act of         2002 |
| 06/16/2004        AIP Procedures—procedures March 5, 1998 |
| 06/10/2004        Revised to update citations Sec. 690.300 Canned Pet Food (CPG 7126.18) |
| 06/15/2004         Correction in classification (Class)—Charles River Laboratories, West         Chester, OH |
| 05/12/2004         John B. Najarian on Restricted List for Clinical Investigators |
| 05/06/2004         March 2004 edition of the Regulatory Procedures Manual (RPM) published.         New edition of FDA RPM is effective May 6th, 2004. All chapters have         been changed except Chapter 9 “Import Operations/Actions.” |
| 04/09/2004         Corrected entry for Arthur Riba on Restricted List for Clinical         Investigators |
| 04/05/2004         Revised Application Integrity Policy List to add Plus Orthopedics, San         Diego, California. |
| 3/12/2004        Revised to update content of August 2000 paper edition:        Sec. 490.100 Process Validation Requirements for Drug Products and         Active Pharmaceutical Ingredients Subject to Pre-Market Approval CPG         7132c.08 |
| 02/23/2004         Revised list to add 1 new member, 02/23/2004: Restricted List for         Clinical Investigators;         Revised list to add 1 new member, 02/23/2004: Disqualified/Totally         Restricted List for Clinical Investigators |
| 02/13/2004        Revised 4 lists of Nonclinical Laboratories Inspected Since Fiscal Year         1990 Updated February 9, 2004 |
| 2/9/2004        Edited two pages to conform text (reference) on Internet pages to August         2000 paper edition: CPG Sec. 515.700 Chocolate & Chocolate Liquor—Adulteration with Insect and Rodent Filth CPG 7105.11         CPG Sec. 515.775 Cocoa Powder, Press Cake—Adulteration with Insect and         Rodent Filth CPG 7105.13 |
| Draft CPG 1/14/2004         Draft CPG (Not for Implementation), Sec. 560.750 “Guidance Levels for Radionuclides in Domestic and Imported Foods, Availability; and Draft         Supporting Document, Supporting Document for Guidance Levels for         Radionuclides in Domestic and Imported Foods.”  When         finalized it will replace the existing CPG. Comments due March 15, 2004—The Draft Guidance—The Draft Guidance—Supporting Statement for Guidance Levels—Supporting Statement for Guidance Levels |
| Revoked 1/5/2004        Sec. 370.200 RIA Analysis of Hair to Detect the Presence of Drugs of         Abuse CPG 7124.06 |
| 2003 Revisions and Updates: |
| New CPG Sec. 110.300—“Registration of Food Facilities Under the Public         Health Security and Bioterrorism Preparedness and Response Act of 2002”         is available at: http://www.cfsan.fda.gov/~furls/cpgreg.html. |
| Revised: Application Integrity Policy Committee Contact Persons list on         12/18/2003 |
| Revised Application Integrity Policy List to add AGA Medical         Corporation, Golden Valley, Minnesota |
| Revised CPGM list on 12/18/2003 by         • added new Drugs program 7356.002M, “Inspections of Licensed Biological         Therapeutic Drug Products”        • added new Veterinary Medicine program 7371.009, “BSE/Ruminant Feed Ban         Inspections”        • added on-line links for Drug programs: 7346.832 “Pre-Approval         Inspections/Investigations”; 7346.843, “Post-Approval Audit         Inspections”; 7356.002A, “Sterile Drug Process Inspections”; 7356.002B,         “Repackers and Relabelers”, 7356.002C, “Radioactive drugs” and         7356.002E, “Compressed medical gases”        • Corrected title of drug program 7356.002 “Drug Manufacturing         Inspections”        • corrected CPGM list by removing previously withdrawn Device programs         7385.002 “Ionizing Radiation Use Control Laboratory Support”, 7385.003         “Federal Facility Use Control and Equipment Performance Survey Program”,         and 7386.006G “WEAC Testing of Medical Devices for Conformance to         Voluntary Standards”        • corrected Device program numbers 7382.014 to 7385.014 and 7385.004 to         7386.009. |
| New CPG Sec. 110.310—“Prior Notice of Imported Food Under the Public         Health Security and Bioterrorism Preparedness and Response Act of 2002”         is available at: http://www.cfsan.fda.gov/~pn/cpgpn.html. |
| Revised Debarment List, 10/22/2003—One person added. Published         10/23/03. |
| Revised list to add 2 new members, 10/17/2003: Disqualified/Totally         Restricted List for Clinical Investigators. Published 10/21/03. |
| Revised Debarment List, 10/10/2003—debarment terminated for one         person; three people added. Published 10/10/03. |
| Added pdf version of Guideline for the Monitoring of Clinical         Investigations, Jan., 1988. Published 9/30/03. |
| Revised list to add 2 new members, 09/09/2003: Restricted List for         Clinical Investigators. Published 09/10/03. |
| Revised 4 lists of Nonclinical Laboratories Inspected Since Fiscal Year         1990, Updated 08/11/2003. Published 09/04/03. |
| Revised Debarment List, 8/8/2003—one person added. Published 8/15/03. |
| Revised Sec. 608.400—Compounding of Drugs for Use in Animals.         Published 7/14/03. |
| Revised 3 lists of Nonclinical Laboratories Inspected Since Fiscal Year          1990, Updated 01/27/3. Published 7/2/03. |
| New CPGM link to Compliance Programs published by CBER: Inspection of         Source Plasma Establishments and Inspections of Licensed Vaccines.         Published 6/6/03. |
| Updated ORA page on Electronic Records/Signatures, 21 CFR Part 11.         Published 6/6/03. |
| Revised Debarment List, 5/9/2003—one person added. Published 5/30/03. |
| Revoked effective 02/19/2003: Compliance Policy Guide, Enforcement         Policy: 21 CFR Part 11; Electronic Records; Electronic Signatures (CPG         7153.17). See: 68 FR 8775 02/25/2003. Published 5/30/03. |
| Revised list to update Dr. J.L. Williams, 5/15/2003:         Disqualified/Totally Restricted List for Clinical Investigators.         Published 5/23/03. |
| Replaced Reference: Good Laboratory Practice (GLP) Final Rule,         12/22/1978. Published 5/23/03. |
| Revised—Four Lists of Nonclinical Laboratories Inspected Since Fiscal         Year  1990, Updated 03/06/2003. Published 5/1/03. |
| Revised Application Integrity Policy List to remove Gliatech, Inc.,         Beachwood, OH; and Solvay Pharmaceuticals, Inc., Beaudette, MN, and         Marietta, GA, April 2003. |
| Revised list to add new member, 04/10/2003: Disqualified/Totally         Restricted List for Clinical Investigators. |
| Revised Debarment List on 04/09/2003—One person removed (Hernandez,         Delfina); One correction inserted (Lai, Elaine). |
| Revised: Application Integrity Policy Committee Contact Persons list.         Updated 3/31/2003. |
| Revised 03/23/2003, HTML/online links changed for Biologics Compliance         Programs 7342.006, 7342.008. and 7345.001 (CBER). No content was         changed. |
| New CPGM, 03/19/2003: Biologics Compliance Program March 2003, 7341.002,         Inspection of Tissue Establishments (CBER). |
| Revoked effective 02/19/2003—Compliance Policy Guide, Enforcement         Policy: 21 CFR Part 11; Electronic Records; Electronic Signatures (CPG         7153.17) See: 68 FR 8775 02/25/2003. |
| Revised list to add new member, 02/10/2003: Disqualified/Totally         Restricted List for Clinical Investigators. |
| Revised Debarment List on 01/13/2003—2 people added. |
| 2002 Revisions and Updates |
| Revised list to add new member, 10/28/2002: Disqualified/Totally         Restricted List for Clinical Investigators. |
| Edited lists 12/16/2002: 1) Inactive Labs List and 2)Active Tox Labs         List |
| Revised Debarment List on 12/03/2002—one person added |
| Typographical errors (1 per page) 11/27/2002: CPGuides Manual—Sec 555.425—Foods—Adulteration Involving Hard or Sharp Foreign         Objects;   and        Sec. 515.350 Candy—Mixed with Trinkets and Sold in Vending Machines         (CPG 7105.04) |
| Edited links 11/27/2002: 21 CFR Part 11 Guidance Documents Dockets         Established—Topics for Guidance Development Revised 11/14/2002: Sec. 555.600 Filth *from Insects, Rodents, and Other         Pests* in Foods (CPG 7120.18) |
| Updated 11/14/2002:  4 lists of  Nonclinical Laboratories Inspected         Since Fiscal Year  1990 |
| Revoked effective 11/12/2002: Sec. 398.475 Minimum X-Ray Field Size for         Spot-Film Operation of Fluoroscopic Systems with Fixed SID and Without         Stepless Adjustment of the Field Size (CPG 7133.17) |
| Revised 11/13/2002 Debarment List—3 people added |
| Revised 2 lists to add new or update member(s), 10/16/2002:        Disqualified/Totally Restricted List for Clinical Investigators and        Restricted List for Clinical Investigators |
| Revoked effective 10/07/2002, Sec. 300.700 Direct Reference Authority         for Class III Medical Devices Without a Premarket Notification (510(k))         or an Approved Premarket Approval Application (PMA) (CPG 7124.30) per         Federal Register, 09/05/2002 (67 FR 56850) |
| Revised Subchapter Import for Export in Chapter 9 of Regulatory         Procedures Manual. 09/13/2002. |
| New—CryoLife, Inc., Kennesaw, GA, 08/13/2002.  Order for Retention,         Recall, and/or Destruction |
| New—Four Lists of Nonclinical Laboratories Inspected Since Fiscal Year          1990. Updated 08/2002 |
| Revised list to add new member, 08/7/2002:        Disqualified/Totally Restricted List for Clinical Investigators |
| Revoked effective on 08/07/2002:        Sec. 315.200 Status of Dental Supplies such as Denture Cleaners,         Adhesives, Cushions, and Repair Materials as a Device or Cosmetic (CPG         7124.05) See 67 FR 45129,   07/08/2002 |
| Revised list to add new member, 06/27/2002:        Restricted List for Clinical Investigators |
| Revised list to add new member, 06/27/2002:        Disqualified/Totally Restricted List for Clinical Investigators |
| Reissued 05/29/2002, Sec. 460.200 Pharmacy Compounding |
| Revoked effective on 06/20/2002, Sec. 391.100 Advertisement Literature         for High-Intensity Mercury Vapor Discharge Lamps (CPG 7133.13) |
| Revoked effective on 06/20/2002, Sec. 396.100 Applicability of the         Sunlamp Performance Standard To UVA Tanning Products (CPG 7133.16) |
| Corrected 05/16/2002, Sec 575.100 Pesticide Residues...Heptachlor table |
| New CPG Sec. 230.150 Blood Donor Classification Statement, Paid or         Volunteer Donor issued 05/07/2002 |
| Revised BioResearch Monitoring Information references added or updated         05/16/2002 |
| Revised Debarment List on 05/07/2002—person added |
| Revised Compliance Program Manual 04/26/2002 page—page text and links         were updated |
| Edited Debarment List on 04/09/2002 |
| Revised as Draft 05/29/2002—Sec. 345.100 Male Condom Defects (CPG         7124.21) for comment |
| Edited page to remove dates that may become obsolete, 04/2/2002:        Application Integrity Policy Information. |
| Revised list to add new member, 04/02/2002:        Disqualified/Totally Restricted List for Clinical Investigators |
| Revised list to add new member, 02/20/2002:        Application Integrity Policy List |
| Revised lists to align members to groups, 01/15/2002:         a) Restricted List for Clinical Investigators        b) Disqualified/Totally Restricted List for Clinical Investigators |
| 2001 Revisions and Updates |
| Revised as Draft Dec 18, 2001—Sec. 555.600 Filth *from Insects,         Rodents, and Other Pests* in Foods (CPG 7120.18) |
| New CPG Oct., 2001—Sec. 510.150 Apple Juice, Apple Juice Concentrates,         and Apple Juice Products—Adulteration with Patulin |
| Reformat CPG Oct., 2001—Sec. 570.425 Tree Nuts—Adulteration         Involving Rejects (Insect Infestation, Moldy, Rancid, Otherwise         Decomposed, Blanks, and Shriveled) (CPG 7112.05) |
| Final CPG April 2001—Sec. 615.115 Extra-Label Use of Medicated Feeds         for Minor Species |
| New CPG April 2001,  Sec. 555.250 Statement of Policy for Labeling and         Preventing Cross-contact of Common Food Allergens |
| New RPM Chapter 5, March, 2001, Subchapter Civil Money Penalties,         Reduction of Civil Money Penalties for Small Entities |
| New RPM Chapter 9, January 2001, Communication Concerning Assessment of         Civil Monetary Penalties by U.S. Customs Service in Cases Involving         Imported Food |
| New RPM Chapter 9, January 2001, Secured Storage |
| 2000 Revisions and Updates |
| Draft CPG—December 2000, Sec. 230.150 Blood Donor Incentives |
| Revised 8/10/2000, Sec. 540.650 Uneviscerated Fish Products that are         Salt-cured, Dried, or Smoked (CPG 7108.17) |
| New 06/29/2000, Sec. 100.950 International Parnership Agreements for         Compliance Activities—Agreements among the USFDA, Foreign Government         Agencies, and Foreign or Domestic Trade Associations and/or Other         Organizations |
| Deleted 07/03/2000, Sec. 405.100 Prescriptions Prepared from Certified         Antibiotics (CPG 7122.01) |
| Deleted 07/03/2000, Sec. 405.200 Export of Uncertified Antibiotics (CPG         7122.02) |
| Deleted 07/03/2000, Sec. 405.210 Returned Antibiotics Exported Under         801(d) of the Act (CPG 7122.03) |
| Revised 05/01/2000, Sec. 651.100 Ethylenediamine Dihydroiodide (EDDI)         (CPG 7125.18) |
| Revised 04/14/2000, Section 110.100, Certification for Exports         (CPG7150.01) |
| Deleted 03/28/2000, Section 215.100, IND Filings: Completion of         Applicable... |
| Reissued 03/22/2000, Section 257.100, Deferral of Source Plasma Donors         Due to Red Cell Loss During Collection of Source Plasma by Automated         Plasmapheresis |
| New 03/06/2000, Section 252.110, Volume Limits for Automated Collection         of Source Plasma |
| Deleted (Revoked) 01/24/2000, Sec. 305.100 Acupuncture Devices and         Accessories (CPG 7124.11) |
| 1999 Revisions and Updates |
| Draft CPG—08/04/1999, Section 615.115 Use of Medicated Feeds for Minor         Species |
| July 9, 1999, Compliance Policy Guide 230.140, Biologics,        Evaluation and Processing Post Donation Information Reports |
| The “Draft Civil Money Penalty Reduction Policy for Small Entities”         published in the Federal Register (FR) on May 18, 1999. See final copy         of the RPM Subchapter   March 20, 2001 |
| New 5/13/1999, Compliance Policy Guide, Enforcement Policy: 21 CFR Part         11; Electronic Records; Electronic Signatures (CPG 7153.17) |
| New, 4/26/1999, Compliance Policy Guide, Y2K Computer Compliance |
| Draft Revised CPG, 4/9/1999, Regulatory Policy on the Disposition of         Publications that Constitute Labeling (CPG 7153.13) (Level I guidance         document (see 62FR8961 2/27/97)) Not for Implementation |
| Welcome to Inspection Reference |
| This page includes information provided to FDA investigators and inspectors to assist them in their daily activities. |
| Field Management Directives—The primary vehicle for distributing procedural information/policy on the management of Office of Regulatory Affairs (ORA) field activities. |
| Guides to Inspections of...—Guidance documents written to assist FDA personnel in applying FDA's regulations, policies and procedures during specific types of inspection or for specific manufacturing processes. Note: These documents are reference material for investigators and other       FDA personnel. The documents do not bind FDA and do not confer any rights,       privileges, benefits or immunities for or on any person(s). An alternative       approach may be used if such an approach satisfies the applicable       statutes, regulations or both.      Updated: June 2005 |
| BIOTECHNOLOGY |
| BIOTECHNOLOGY INSPECTION GUIDE (11/91) |
| BIOLOGICS |
| BLOOD BANKS (9/94) |
| SOURCE PLASMA ESTABLISHMENTS (Rev 4/01) |
| INFECTIOUS DISEASE MARKER TESTING FACILITIES (6/96) |
| VIRAL CLEARANCE PROCESSES FOR PLASMA DERIVATIVES |
| COMPUTER ISSUES |
| COMPUTERIZED SYSTEMS IN DRUG ESTABLISHMENTS (2/83) |
| COMPUTERIZED SYSTEM IN THE FOOD PROCESSING INDUSTRY |
| GLOSSARY COMP. SYSTEMS. SOFTWARE DEVELOPMENT TERMINOLOGY (8/95) |
| DEVICES |
| QUALITY SYSTEMS |
| ELECTROMAGNECTIC COMPATIBILITY ASPECTS OF MEDICAL DEVICE QUALITY           SYSTEMS |
| BIORESEARCH MONITORING INSPECTIONS OF IN VITRO DIAGNOSTIC DEVICES |
| MAMMOGRAPHY QUALITY STANDARDS ACT AUDITOR'S GUIDE |
| MEDICAL DEVICE MANUFACTURERS |
| DRUGS |
| BULK PHARMACEUTICAL CHEMICALS (9/91) |
| HIGH PURITY WATER SYSTEMS (7/93) |
| LYOPHILIZATION OF PARENTERALS (7/93) |
| MICROBIOLOGICAL. PHARMACEUTICAL QUALITY CONTROL LABS (7/93) |
| PHARMACEUTICAL QUALITY CONTROL LABORATORIES (7/93) |
| VALIDATION OF CLEANING PROCESSES (7/93) |
| DOSAGE FORM DRUG MANUFACTURERS—CGMP'S (10/93) |
| ORAL SOLID DOSAGE FORMS PRE/POST APPR. ISSUES (1/94) |
| STERILE DRUG SUBSTANCE MANUFACTURERS (7/94) |
| TOPICAL DRUG PRODUCTS (7/94) |
| ORAL SOLUTIONS AND SUSPENSIONS (8/94) |
| FOODS COSMETICS |
| ALLERGY INSPECTION GUIDE (April, 2001) |
| ASEPTIC PROCESSING AND PACKAGING FOR THE FOOD INDUSTRY |
| NUTRITIONAL LABELING AND EDUCATION ACT (NLEA) REQUIREMENTS (8/94-2/95) |
| COSMETIC PRODUCT MANUFACTURERS (2/95) |
| COMPUTERIZED SYSTEMS IN THE FOOD PROCESSING INDUSTRY |
| GRAIN PRODUCT MANUFACTURERS |
| INTERSTATE CARRIERS AND SUPPORT FACILITIES (4/95) |
| DAIRY PRODUCT MANUFACTURERS (4/95) |
| MISCELLANEOUS FOOD PRODUCTS—VOL. 1 (5/95) |
| MISCELLANEOUS FOOD PRODUCTS—VOL. 2 (9/96) |
| LOW ACID CANNED FOOD MANUFACTURERS Part 1—ADMINISTRATIVE           PROCEDURES/SCHEDULED PROCESSES |
| LOW ACID CANNED FOOD MANUFACTURERS Part 2—PROCESSES/PROCEDURES |
| LOW ACID CANNED FOOD MANUFACTURERS Part 3—CONTAINERS/CLOSURES           (11/98) |
| ACIDIFIED FOOD MANUFACTURERS |
| TRACEBACK OF FRESH FRUITS AND VEGETABLES IMPLICATED IN EPIDEMIOLOGICAL           INVESTIGATIONS |
| SALMONELLA ENTERITIDIS (SE) GUIDE TO TRACEBACK IN EGGS (07/03/2003) |
| MISCELLANEOUS |
| FOREIGN MEDICAL DEVICE MANUFACTURERS (9/95) |
| FOREIGN PHARMACEUTICAL MANUFACTURERS (5/96) |
| IOM: Investigations Operations Manual 2006 Centennial Edition—Primary procedure manual for FDA personnel performing inspections and special investigations. |
| Guide to International Inspections  and Travel—Procedure manual for FDA personnel performing inspections and other FDA-related activities abroad. |
| Inspection Technical Guides—Guidance documents that provide FDA personnel with technical background in a specific piece of equipment. or a specific manufacturing or laboratory procedure, or a specific inspectional technique, etc. |
| 1. Introductory IssueAll Programs 1/20/72 |
| 2. Steam Generation in Canneries Food Canneries 2/11/72 |
| 3. Steam Distribution for Retort            Venting in Food Canneries Food Canneries 3/03/72 |
| 4. New Equipment Kenics             Static Mixers Food, Drug and Cosmetic 3/20/72 |
| 5.Ethylene Oxide             Sterilization 1.             Calculation of Initial             Gas Concentration Drugs, Sterile Devices 6/09/72 |
| 6. Leak Testing Sealed Ampuls             of Parenteral Solutions Drugs, Human and Veterinary Injectable             Vitamins 4/28/72 |
| 7. Sterilizing Symbols             (D, Z, F) Low Acid Canned Foods 1/09/72 |
| 8. “Package Unit” Italian Flour Mills Cereal Flours & Related             Products 12/14/72 |
| 9. Polariscope Sterile Packaging—Foods, Drugs, Devices, Hardened             Lenses 5/21/73 |
| 10. Diathermy Medical Devices 5/21/73 |
| 11. Steam Pressure for             Retorts and Autoclaves Sterile Drugs and Devices Low Acid Canned             Foods, Biologics 6/29/73 |
| 12. Stroboscope Food, Drug, Device, Manufacture and Packaging 8/08/73 |
| 13. Field Submission of             Articles All Programs 9/05/73             (8/03/84 Revised) |
| 14. Thermocouple Surface             Pyrometers Food Canneries12/20/73 |
| 15. Common Valves Used in            Process Fluid Systems Sterile Drugs, Devices, Low Acid Canned Foods             and Biologics 1/15/74 |
| 16. A.T.I. Steam Activated             Heat Sensitive Indicators Food, Drugs, Medical Devices 3/08/74 |
| 17. New Source of Lead and            Other Contamination Various Foods and Drugs 6/18/74 |
| 18. Ultrasound in the Food,            Drug, and Device Industries Food, Drugs, and Medical Devices 3/03/75 |
| 19. Screening Electronic            Components Medical Devices 4/20/75 |
| 20. Hermetically Sealed            Electronic Component             Leak Detection Medical Devices 7/18/75 |
| 21. Noise Control Mufflers            for Bleeders on Retorts and Sterilizers Food, Drugs 9/15/75 |
| 22. Ground Fault Circuit            Interrupter All Programs, Personnel Safety 3/05/76 |
| 23. The Computer in FDA            Regulated Industries Foods, Drugs, and Medical Devices 5/21/76 |
| 24. Air Velocity Meters Sterile Drugs and Devices, Foods and             Cosmetics 7/30/76 |
| 25. Ethylene Oxide             Sterilization 2. Graphical Aid to Determine Gas Concentration Sterile             Devices, Drugs 9/01/76 |
| 26. Evaluation of Production Cleaning Processes for Electronic Medical             Devices—Part 1, Contaminants Medical Devices 1/07/77 |
| 27. Evaluation of Production            Cleaning Processes for Electronic Medical Devices—Part II,             Cleaning Solvents Medical Devices 1/07/77 |
| 28. Evaluation of Production            Cleaning Processes for Electronic Medical Devices—Part III,             Methods Medical Devices 1/07/77 |
| 29. The Computer in FDA            Regulated Industries—Part II Computer Hardware All Programs 9/22/77 |
| 30. The Nation is Going Metric            (rescinded) All Programs 12/02/77 |
| 31. Electronic Components—Resistors Medical Devices, Radiological Health 1/16/78 |
| 32. Pyrogens, Still a Danger Parenterals, Biologicals, Devices,             Drugs 1/12/79 |
| 33. Use of the Texas Instruments             Model 59 Programmable Calculator in the Enforcement of the             Diagnostic X-ray Performance Standard X-Ray Field Testing 7/12/79 |
| 34. Heat Exchangers to Avoid             Contamination Drugs, Diagnostic Products Biologics 7/31/79 |
| 35. Reliability of Manufactured            Products Medical Device, Radiological Health Products 9/26/80 |
| 36. Reverse Osmosis Drugs, Medical Devices and Diagnostic             Products 10/21/80 |
| 37. Temperature Sensors in             the Regulated Industry Foods, Drugs, Biologics, Medical Devices and             Diagnostic Products 1/7/83 |
| 38. Industrial Applications of            New Biochemical Technolgy All Programs 8/1/83 |
| 39. Water Activity (a{{w}}) in Foods Foods 4/16/84 |
| 40. Bacterial Endotoxins/Pyrogens Drugs and Devices 3/20/85 |
| 41. Expiration Dating and            Stability Testing for Human Drug Products Drugs 10/18/85 |
| 42. Tin Whiskers—Problems,            Causes, and Solutions Medical Devices 3/14/86 |
| 43. Lyophilization of Parenterals Drugs, Biologics, Diagnostics 4/18/86 |
| 44. Radiation Protection Terminology Foods 5/15/86 |
| 45. Circular Temperature Recording            Chart Measurements All Programs 2/20/87 |
| 46. Water for Pharmaceutical Use Drugs, Biologics, Medical             Devices 12/31/86 |
| 47. Measurement of Relative Humidity            in the ETO Process Drugs and Medical Devices 4/30/87 |
| 48. Microbiological Contamination            of Equipment Gaskets with Product Contact All Programs 12/31/86 |
| 49. Stock Rotomat Foods 5/30/87 |
| 50. Capacitor Medical Devices/Radiological Health 10/23/87 |
| 51. Electronic Relays Medical Devices/Radiological Health 11/10/87 |
| 52. Voice Recognition Systems GLP and Devices 11/10/87 |
| Medical Device GMP Reference Information—(link to page maintained by CDRH) |
| QS Regulation/Design Controls |

Dated: March 7, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.