# Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 057
**AGENCY:**
Food and Drug Administration, Health and Human Services (HHS).
**ACTION:**
Notice.
**SUMMARY:**
The Food and Drug Administration (FDA or Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled “Modifications to the List of Recognized Standards, Recognition List Number: 057” (Recognition List Number: 057), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
**DATES:**
Submit either electronic or written comments on the notice at any time. These modifications to the list of recognized standards are applicable April 22, 2022.
**ADDRESSES:**
You may submit comments on the current list of FDA Recognized Consensus Standards at any time as follows:
**Electronic Submissions**
Submit electronic comments in the following way:
• *Federal eRulemaking Portal:**https://www.regulations.gov.* Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to *https://www.regulations.gov* will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on *https://www.regulations.gov.*
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
**Written/Paper Submissions**
Submit written/paper submissions as follows:
• *Mail/Hand Delivery/Courier (for written/paper submissions):* Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
*Instructions:* All submissions received must include the Docket No. FDA-2004-N-0451 for “Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 057.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at *https://www.regulations.gov* or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. FDA will consider any comments received in determining whether to amend the current listing of modifications to the list of recognized standards, Recognition List Number: 057.
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION”. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on *https://www.regulations.gov.* Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: *https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.*
*Docket:* For access to the docket to read background documents or the electronic and written/paper comments received, go to *https://www.regulations.gov* and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
An electronic copy of Recognition List Number: 057 is available on the internet at *https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.* See section IV for electronic access to the searchable database for the current list of FDA-recognized consensus standards, including Recognition List Number: 057 modifications and other standards-related information. Submit written requests for a single hard copy of the document entitled “Modifications to the List of Recognized Standards, Recognition List Number: 057” to Scott Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5606, Silver Spring, MD 20993, 301-796-6287. Send one self-addressed adhesive label to assist that office in processing your request, or Fax your request to 301-847-8144.
**FOR FURTHER INFORMATION CONTACT:**
Scott Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5606, Silver Spring, MD 20993, 301-796-6287, *[email protected].*
**SUPPLEMENTARY INFORMATION:**
**I. Background**
Section 204 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions or other requirements.
In the *Federal Register* of September 14, 2018 (83 FR 46738), FDA announced the availability of a guidance entitled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.” The guidance describes how FDA has implemented its standards recognition program and is available at *https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-standards-premarket-submissions-medical-devices.* Modifications to the initial list of recognized standards, as published in the *Federal Register**,* can be accessed at *https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/federal-register-documents.*
These notices describe the addition, withdrawal, and revision of certain standards recognized by FDA. The Agency maintains on its website hypertext markup language (HTML) and portable document format (PDF) versions of the list of FDA Recognized Consensus Standards, available at *https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/federal-register-documents.* Additional information on the Agency's Standards and Conformity Assessment Program is available at *https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standards-and-conformity-assessment-program.*
**II. Modifications to the List of Recognized Standards, Recognition List Number: 057**
FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the Agency is recognizing for use in premarket submissions and other requirements for devices. FDA is incorporating these modifications to the list of FDA Recognized Consensus Standards in the Agency's searchable database. FDA is using the term “Recognition List Number: 057” to identify the current modifications.
In table 1, FDA describes the following modifications: (1) The withdrawal of standards and their replacement by others, if applicable; (2) the correction of errors made by FDA in listing previously recognized standards; and (3) the changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of the standards.
In section III, FDA lists modifications the Agency is making that involve new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 057.
| Old | Replacement | Title of standard | Change |
| --- | --- | --- | --- |
| | | | |
| No new entries at this time. | | | |
| | | | |
| 2-275 | | ISO 10993-7 Second edition 2008-10-15 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009), AMENDMENT 1: Applicability of allowable limits for neonates and infants (2019)] | Title change. |
| 2-284 | 2-292 | USP-NF M98833_01_01 <87> Biological Reactivity Test, In Vitro—Direct Contact Test | Withdrawn and replaced with newer version. |
| 2-285 | 2-293 | USP-NF M98833_01_01 <87> Biological Reactivity Test, In Vitro—Elution Test | Withdrawn and replaced with newer version. |
| 2-286 | 2-294 | USP-NF M98834_01_01 <88> Biological Reactivity Tests, In Vivo | Withdrawn and replaced with newer version. |
| 2-287 | 2-295 | USP-NF M98900_01_01 <151> Pyrogen Test (USP Rabbit Test). | Withdrawn and replaced with newer version. |
| | | | |
| 3-88 | 3-171 | ASTM F2514-21 Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading | Withdrawn and replaced with newer version. |
| 3-99 | 3-172 | AAMI TIR42:2021 Evaluation of particulate associated with vascular medical devices | Withdrawn and replaced with newer version. |
| 3-133 | 3-173 | ISO 5840-3 Second edition 2021-01 Cardiovascular implants—Cardiac valve prostheses—Part 3: Heart valve substitutes implanted by transcatheter techniques | Withdrawn and replaced with newer version. |
| 3-145 | 3-174 | ISO 5840-1 Second edition 2021-01 Cardiovascular implants—Cardiac valve prostheses—Part 1: General requirements | Withdrawn and replaced with newer version. |
| 3-147 | 3-175 | ISO 5840-2 Second edition 2021-01 Cardiovascular implants—Cardiac valve prostheses—Part 2: Surgically implanted heart valve substitutes | Withdrawn and replaced with newer version. |
| | | | |
| 4-89 | | ANSI/ADA Standard No. 53—2008 (R2013) Polymer-Based Crown and Bridge Materials | Withdrawn. |
| 4-282 | 4-284 | ISO 10873 Second edition 2021-07 Dentistry—Denture adhesives | Withdrawn and replaced with newer version. |
| | | | |
| 5-117 | 5-134 | ISO 15223-1 Fourth edition 2021-07 Medical devices—Symbols to be used with medical device labels, labelling, and information to be supplied—Part 1: General requirements | Withdrawn and replaced with newer version. |
| | | | |
| 19-34 | 19-41 | ANSI/UL 61010-1 3rd Ed, dated May 12, 2012 with revision through July 19, 2019 Standard for Safety for Electrical Equipment For Measurement, Control and Laboratory Use; Part 1: General Requirements | Withdrawn and replaced with newer version. |
| | | | |
| 6-365 | 6-464 | ISO 11040-4 Third edition 2015-04-01 Prefilled syringes—Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling [Including AMENDMENT 1 (2020)] | Withdrawn and replaced with newer version. |
| 6-451 | 6-465 | USP-NF M76090_03_01 Sodium Chloride Irrigation | Withdrawn and replaced with newer version. |
| 6-452 | 6-466 | USP-NF M76070_03_01 Sodium Chloride Injection | Withdrawn and replaced with newer version. |
| 6-453 | 6-467 | USP-NF M80200_04_01 Nonabsorbable Surgical Suture | Withdrawn and replaced with newer version. |
| 6-454 | 6-468 | USP-NF M99670_02_01 <881> Tensile Strength | Withdrawn and replaced with newer version. |
| 6-455 | 6-469 | USP-NF M99650_02_01 <861> Sutures—Diameter | Withdrawn and replaced with newer version. |
| 6-456 | 6-470 | USP-NF M99660_03_01 <871> Sutures—Needle Attachment | Withdrawn and replaced with newer version. |
| 6-457 | 6-471 | USP-NF M88880_05_01 Sterile Water for Irrigation | Withdrawn and replaced with newer version. |
| 6-458 | 6-472 | USP-NF M36660_04_01 Heparin Lock Flush Solution. | Withdrawn and replaced with newer version. |
| 6-459 | 6-473 | USP-NF M80190_04_01 Absorbable Surgical Suture | Withdrawn and replaced with newer version. |
| | | | |
| No new entries at this time. | | | |
| | | | |
| 8-103 | 8-563 | ASTM F1801-20 Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials | Withdrawn and replaced with newer version. |
| 8-121 | 8-564 | ASTM F2005-21 Standard Terminology for Nickel-Titanium Shape Memory Alloys | Withdrawn and replaced with newer version. |
| 8-193 | 8-565 | ASTM F2754/F2754M-21 Standard Test Method for Measurement of Camber Cast Helix and Direction of Helix of Coiled Wire | Withdrawn and replaced with newer version. |
| 8-346 | 8-566 | ASTM F1813-21 Standard Specification for Wrought Titanium—12 Molybdenum—6 Zirconium—2 Iron Alloy for Surgical Implant (UNS R58120) | Withdrawn and replaced with newer version. |
| 8-353 | 8-567 | ASTM F86-21 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants | Withdrawn and replaced with newer version. |
| 8-355 | 8-568 | ASTM F1586-21 Standard Specification for Wrought Nitrogen Strengthened 21 Chromium-10 Nickel-3 Manganese-2.5 Molybdenum Stainless Steel Bar for Surgical Implants (UNS S31675) | Withdrawn and replaced with newer version. |
| 8-385 | 8-569 | ASTM F648-21 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants | Withdrawn and replaced with newer version. |
| 8-398 | 8-570 | ASTM F1108-21 Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants | Withdrawn and replaced with newer version. |
| 8-422 | 8-571 | ASTM F2052-21 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment | Withdrawn and replaced with newer version. |
| 8-423 | 8-572 | ASTM F2565-21 Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications | Withdrawn and replaced with newer version. |
| 8-424 | 8-573 | ASTM F2695-12(2020) Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications | Withdrawn and replaced with newer version. |
| 8-425 | 8-574 | ASTM F2820-12(2021)e1 Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications | Withdrawn and replaced with newer version. |
| 8-443 | 8-575 | ASTM F3160-21 Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants | Withdrawn and replaced with newer version. |
| 8-450 | 8-576 | ASTM F451-21 Standard Specification for Acrylic Bone Cement | Withdrawn and replaced with newer version. |
| 8-456 | 8-577 | ISO 13179-1 Second Edition 2021-09 Implants for surgery—Coatings on metallic surgical implants—Part 1: Plasma-sprayed coatings derived from titanium or titanium-6 aluminum-4 vanadium alloy powders | Withdrawn and replaced with newer version. Title change. |
| 8-460 | 8-578 | ASTM F2848-21 Standard Specification for Medical-Grade Ultra-High-Molecular-Weight Polyethylene Yarns | Withdrawn and replaced with newer version. |
| 8-515 | 8-579 | ISO 13779-3 Second Edition 2018-12 Implants for surgery—Hydroxyapatite—Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity [Including AMENDMENT 1 (2021)] | Withdrawn and replaced with newer version. |
| | | | |
| No new entries at this time. | | | |
| | | | |
| No new entries at this time. | | | |
| | | | |
| No new entries at this time. | | | |
| | | | |
| 10-73 | 10-127 | ANSI Z80.21-2020 American National Standard for Ophthalmics—Instruments—General-Purpose Clinical Visual Acuity Charts | Withdrawn and replaced with newer version. |
| 10-87 | 10-128 | ASTM D882-18 Standard Test Method for Tensile Properties of Thin Plastic Sheeting | Withdrawn and replaced with newer version. |
| 10-88 | 10-129 | ASTM D790-17 Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials | Withdrawn and replaced with newer version. |
| 10-102 | 10-130 | ANSI Z80.36-2021 American National Standard for Ophthalmics—Light Hazard Protection for Ophthalmic Instruments | Withdrawn and replaced with newer version. |
| | | | |
| 11-239 | 11-385 | ASTM F2345-21 Standard Test Methods for Determination of Cyclic Fatigue Strength of Ceramic Modular Femoral Heads | Withdrawn and replaced with newer version. |
| 11-266 | 11-386 | ASTM F2665-21 Standard Specification for Total Ankle Replacement Prosthesis | Withdrawn and replaced with newer version. |
| 11-305 | 11-387 | ASTM F1781-21 Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants | Withdrawn and replaced with newer version. |
| 11-345 | 11-388 | ASTM F1717-21 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model | Withdrawn and replaced with newer version. |
| 11-359 | 11-389 | ISO 7206-10 Second edition 2018-08 Implants for surgery—Partial and total hip-joint prostheses—Part 10: Determination of resistance to static load of modular femoral heads [Including AMENDMENT 1 (2021)] | Withdrawn and replaced with newer version. |
| | | | |
| No new entries at this time. | | | |
| | | | |
| 12-299 | 12-341 | IEC 62563-1 Edition 1.2 2021-07 CONSOLIDATED VERSION Medical electrical equipment—Medical image display systems—Part 1: Evaluation methods | Withdrawn and replaced with newer version. |
| 12-300 | 12-342 | NEMA DICOM PS 3.1—3.20 2021e Digital Imaging and Communications in Medicine (DICOM) Set | Withdrawn and replaced with newer version. |
| | | | |
| 13-46 | | ASTM F2761-09 (2013) Medical Devices and Medical Systems—Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE)—Part 1: General requirements and conceptual model | Withdrawn. See 13-120. |
| | | | |
| 14-424 | 14-563 | ISO 13408-6 Second edition 2021-04 Aseptic processing of health care products—Part 6: Isolator systems | Withdrawn and replaced with newer version. |
| 14-555 | 14-564 | USP-NF M98910_01_01 <161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests | Withdrawn and replaced with newer version. |
| 14-556 | 14-565 | USP-NF M98802_01_01 <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms | Withdrawn and replaced with newer version. |
| 14-557 | 14-566 | USP-NF M98795_02_01 <55> Biological Indicators—Resistance Performance Tests | Withdrawn and replaced with newer version. |
| 14-558 | 14-567 | USP-NF M7414_01_01 <1229.5> Biological Indicators for Sterilization | Withdrawn and replaced with newer version. |
| 14-559 | 14-568 | USP-NF M98800_01_01 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests | Withdrawn and replaced with newer version. |
| 14-560 | 14-569 | USP-NF M98810_01_01 <71> Sterility Tests | Withdrawn and replaced with newer version. |
| 14-561 | 14-570 | USP-NF M98830_02_01 <85> Bacterial Endotoxins Test | Withdrawn and replaced with newer version. |
| | | | |
| 15-29 | | ASTM F2259-10 (Reapproved 2012)e1 Standard Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic Resonance (1H NMR) Spectroscopy | Withdrawn. |
**III. Listing of New Entries**
In table 2, FDA provides the listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 057. These entries are of standards not previously recognized by FDA.
| Recognition | Title of standard | Reference No. and date |
| --- | --- | --- |
| | | |
| No new entries at this time. | | |
| | | |
| No new entries at this time. | | |
| | | |
| 3-176 | Cardiovascular implants and artificial organs—Cannulae for extracorporeal circulation | ISO 18193 First edition 2021-08. |
| 3-177 | Standard Guide for Three-Point Bending of Balloon-Expandable Vascular Stents and Stent Systems | ASTM F2606-08 (Reapproved 2021). |
| 3-178 | Standard Guide for Radial Loading of Balloon-Expandable and Self-Expanding Vascular Stents | ASTM F3067-14 (Reapproved 2021). |
| 3-179 | Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices | ASTM F3172-15 (Reapproved 2021). |
| 3-180 | Standard Test Method for Stent and Endovascular Prosthesis Kink Resistance | ASTM F3505-21. |
| | | |
| 4-285 | Dental Abrasive Powders | ANSI/ADA Standard No. 37—1986 (R2020). |
| 4-286 | Dental Impression Trays | ANSI/ADA Standard No. 87—1995 (R2014). |
| 4-287 | Oral Rinses (Modified adoption of ISO 16408:2015, Dentistry Oral Care Products—Oral Rinses) | ANSI/ADA Standard No. 116—2020. |
| 4-288 | Dentistry—Mixing machines for dental amalgam | ISO 7488 Second edition 2018-04. |
| 4-289 | Dentistry—Intraoral spatulas | ISO 18556 First edition 2016-04. |
| 4-290 | Dentistry—Integrated dental floss and handles | ISO 28158 Second edition 2018-09. |
| 4-291 | Dentistry—Products for external tooth bleaching | ISO 28399 First edition 2011-01. |
| 4-292 | Dentistry—Screening method for erosion potential of oral rinses on dental hard tissues | ISO 28888 First edition 2013-10. |
| | | |
| No new entries at this time. | | |
| | | |
| 19-42 | Electrical equipment for measurement, control and laboratory use—EMC requirements—Part 1: General requirements | IEC 61326-1 Edition 3.0 2020-10. |
| 19-43 | Electrical equipment for measurement, control and laboratory use—EMC requirements—Part 2-6: Particular requirements—In vitro diagnostic (IVD) medical equipment | IEC 61326-2-6 Edition 3.0 2020-10. |
| 19-44 | American National Standard—Recommended Practice for In Situ RF Immunity Evaluation of Electronic Devices and Systems | ANSI/IEEE C63.24-2021. |
| | | |
| 6-474 | Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities | ASTM F3352-19. |
| | | |
| 7-309 | Radiological protection—Performance criteria for laboratories using the cytokinesis block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry | ISO 17099 First edition 2014-11-15. |
| 7-310 | Radiological protection—Performance criteria for service laboratories performing biological dosimetry by cytogenetics | ISO 19238 Second edition 2014-02-01. |
| 7-311 | A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests | CLSI EP39, 1st Edition |
| | | |
| 8-580 | Eyewear display—Part 20-10: Fundamental measurement methods—Optical properties | IEC 63145-20-10 Edition 1.0 2019-08. |
| 8-581 | Eyewear display—Part 20-20: Fundamental measurement methods—Image quality | IEC 63145-20-20 Edition 1.0 2019-09. |
| 8-582 | Eyewear display—Part 22-10: Specific measurement methods for AR type—Optical properties | IEC 63145-22-10 Edition 1.0 2020-01. |
| | | |
| 18-19 | Nanotechnologies—Measurements of particle size and shape distributions by scanning electron microscopy | ISO 19749 First edition 2021-07. |
| 18-20 | Standard Guide for Visualization and Identification of Nanomaterials in Biological and Nonbiological Matrices Using Darkfield Microscopy/Hyperspectral Imaging (DFM/HSI) Analysis | ASTM E3275-21. |
| | | |
| No new entries at this time. | | |
| | | |
| No new entries at this time. | | |
| | | |
| No new entries at this time. | | |
| | | |
| 11-390 | Implants for surgery—Pre-clinical mechanical assessment of spinal implants and particular requirements—Part 2: Spinal intervertebral body fusion devices | ISO 23089-2 First edition 2021-05. |
| 11-391 | Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops | ASTM F2722-21. |
| 11-392 | Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation | ASTM F2723-21. |
| 11-393 | Standard Test Method for Evaluating Mobile Bearing Knee Dislocation | ASTM F2724-21. |
| | | |
| 16-232 | Medical electrical equipment—Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation | IEC 80601-2-78 Edition 1.0 2019-07. |
| | | |
| No new entries at this time. | | |
| | | |
| 13-120 | Medical Devices and Medical Systems—Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE)—Part 1: General requirements and conceptual model | ANSI/AAMI 2700-1:2019. |
| | | |
| 14-571 | Sterilization of health care products—Biological indicators—Part 8: Method for validation of a reduced incubation time for a biological indicator | ISO 11138-8 First edition 2021-07. |
| | | |
| No new entries at this time. | | |
**IV. List of Recognized Standards**
FDA maintains the current list of FDA Recognized Consensus Standards in a searchable database that may be accessed at *https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.* Such standards are those that FDA has recognized by notice published in the *Federal Register* or that FDA has decided to recognize but for which recognition is pending (because a periodic notice has not yet appeared in the *Federal Register* ). FDA will announce additional modifications and revisions to the list of recognized consensus standards, as needed, in the *Federal Register* once a year, or more often if necessary.
**V. Recommendation of Standards for Recognition by FDA**
Any person may recommend consensus standards as candidates for recognition under section 514 of the FD&C Act by submitting such recommendations, with reasons for the recommendation, to *[email protected].* To be considered, such recommendations should contain, at a minimum, the information available at *https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standards-and-conformity-assessment-program#process.*
Dated: April 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.