# Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments
**AGENCY:**
Food and Drug Administration, HHS.
**ACTION:**
Notice; request for comments.
**SUMMARY:**
The Food and Drug Administration (FDA or Agency) has identified a list of class II devices that, when finalized, will be exempt from premarket notification requirements, subject to certain limitations. FDA is publishing this notice of that determination and requesting public comment in accordance with procedures established by the 21st Century Cures Act. This notice does not represent FDA's final determination with respect to the class II devices included in this document. FDA will review any comments submitted within the 60-day comment period and will consider whether the list of class II devices should be modified prior to publication of its final determination in the *Federal Register* .
**DATES:**
Submit either electronic or written comments on the notice by May 15, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before May 15, 2017. The *https://www.regulations.gov* electronic filing system will accept comments until midnight Eastern Time at the end of May 15, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.
**ADDRESSES:**
You may submit comments 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):* Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Division of Dockets Management, 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-2017-N-1129 for “Medical Devices; Exemptions from Premarket Notification: Class II Devices.” Received comments, those filed in a timely manner (see *DATES* ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at *https://www.regulations.gov* or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
• 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 Division of Dockets Management. 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.gpo.gov/fdsys/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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
**FOR FURTHER INFORMATION CONTACT:**
Bryce Bennett, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5244, Silver Spring, MD 20993, 301-348-1446, email: *[email protected].*
**SUPPLEMENTARY INFORMATION:**
**I. Background**
Under section 513 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c), FDA must classify devices into one of three regulatory classes: Class I, class II, or class III. FDA classification of a device is determined by the amount of regulation necessary to provide a reasonable assurance of safety and effectiveness. Under the Medical Device Amendments of 1976 (1976 amendments) (Pub. L. 94-295), and the amendments of the Safe Medical Devices Act of 1990 (Pub. L. 101-629), devices are to be classified into class I (general controls) if there is information showing that the general controls of the FD&C Act are sufficient to assure safety and effectiveness; into class II (special controls), if general controls, by themselves, are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide such assurance; and into class III (premarket approval), if there is insufficient information to support classifying a device into class I or class II and the device is a life sustaining or life supporting device or is for a use which is of substantial importance in preventing impairment of human health or presents a potential unreasonable risk of illness or injury.
Most generic types of devices that were on the market before the date of the 1976 amendments (May 28, 1976) (generally referred to as preamendments devices) have been classified by FDA under the procedures set forth in section 513(c) and (d) of the FD&C Act through the issuance of classification regulations into one of these three regulatory classes. Devices introduced into interstate commerce for the first time on or after May 28, 1976 (generally referred to as postamendments devices) are classified through the premarket notification process under section 510(k) of the FD&C Act (21 U.S.C. 360(k)). Section 510(k) of the FD&C Act and the implementing regulations, part 807 of Title 21 of the Code of Federal Regulations (CFR), require persons who intend to market a new device to submit a premarket notification (510(k)) containing information that allows FDA to determine whether the new device is “substantially equivalent” within the meaning of section 513(i) of the FD&C Act to a legally marketed device that does not require premarket approval.
On December 13, 2016, the President signed into law the 21st Century Cures Act (Pub. L. 114-255). Section 3054 of the 21st Century Cures Act amended section 510(m) of the FD&C Act. As amended, section 510(m)(1)(A) of the FD&C Act requires FDA to publish in the *Federal Register* a notice containing a list of each type of class II device that FDA determines no longer requires a report under section 510(k) of the FD&C Act to provide reasonable assurance of safety and effectiveness. FDA is required to publish this notice within 90 days of the date of enactment of the 21st Century Cures Act and at least once every 5 years thereafter, as FDA determines appropriate. Additionally, FDA must provide at least a 60-day comment period for any such notice required to be published under section 510(m)(1)(A) of the FD&C Act. Within 210 days of enactment of the 21st Century Cures Act, FDA must publish in the *Federal Register* a list representing its final determination regarding the exemption of the devices that were contained in the present list published under section 510(m)(1)(A) of the FD&C Act. Section 510(m)(3) of the FD&C Act provides that upon the date of publication of the final list in the *Federal Register* , a 510(k) will no longer be required for these devices and the classification regulation applicable to each such type of device shall be deemed amended to incorporate such exemption.
In a final action, and after considering comments, FDA intends to amend the codified language for each listed regulation to reflect the final determination with respect to exempt devices. FDA's final action will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with Federal regulation. Specifically, regulated industry will no longer have to invest time and resources in 510(k) notifications, including preparation of documents and data for submission to FDA, payment of user fees associated with 510(k) submissions, and responding to questions and requests for additional information from FDA during 510(k) review.
**II. Criteria for Exemption**
There are a number of factors FDA may consider to determine whether a 510(k) is necessary to provide reasonable assurance of the safety and effectiveness of a class II device. These factors are discussed in the guidance the Agency issued on February 19, 1998, entitled “Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff” (Ref. 1).
**III. Limitations on Exemptions**
FDA believes that the types of class II devices listed in this notice should be exempt from the premarket notification requirements found under section 510(k) of the FD&C Act. However, an exemption from the requirement of premarket notification does not mean that the device is exempt from any other statutory or regulatory requirements, unless such exemption is explicitly provided by order or regulation. FDA's initial determination that premarket notification is unnecessary to provide a reasonable assurance of safety and effectiveness for devices listed in this document is based, in part, on the assurance of safety and effectiveness that other regulatory controls, such as current good manufacturing practice requirements, provide.
In addition to being subject to the general limitations to the exemptions found in §§ 862.9 to 892.9) 21 CFR 862.9 to 892.9, FDA may partially limit the exemption from premarket notification requirements to specific devices within a listed device type. In table 1, for example, FDA is listing the exemption of the endoscopic magnetic retriever, but limits the exemption to such devices that are for single use. All other endoscopic magnetic retrievers are still subject to premarket notification requirements because FDA determined that premarket notification is necessary to provide a reasonable assurance of safety and effectiveness for these devices.
**IV. List of Class II Devices**
FDA is identifying the following list of class II devices that, if finalized, would no longer require premarket notification under section 510(k) of the FD&C Act, subject to the general limitations to the exemptions found in §§ 862.9 to 892.9:
| 21 CFR section | Device type | Product code | Partial exemption limitation |
| --- | --- | --- | --- |
| 862.1020 | Acid Phosphatase, Nitrophenylphosphate | CJN | |
| 862.1020 | Acid Phosphatase, Thymol Blue Monophosphate | CJR | |
| 862.1020 | Acid Phosphatase, Disodium Phenylphosphate | CJX | |
| 862.1020 | Acid Phosphatase, Naphthyl Phosphate | CKB | |
| 862.1020 | Acid Phosphatase, Thymolphthale Inmonophosphate | CKE | |
| 862.1020 | Acid Phosphatase, Beta Glycerophosphate | CKH | |
| 862.1020 | Acid Phosphatase (Prostatic), Tartrate Inhibited | JFH | |
| 862.1090 | Radioassay, Angiotensin Converting Enzyme | KQN | |
| 862.1100 | Vanillin Pyruvate, AST/SGOT | CIF | |
| 862.1100 | Diazo, AST/SGOT | CIQ | |
| 862.1100 | Hydrazone Colorimetry, AST/SGOT | CIS | |
| 862.1100 | NADH Oxidation/NAD Reduction, AST/SGOT | CIT | |
| 862.1150 | Calibrator, Primary | JIS | |
| 862.1150 | Calibrator, Secondary | JIT | |
| 862.1150 | Calibrator, Surrogate | JIW | |
| 862.1150 | Calibrator, Multi-Analyte Mixture | JIX | |
| 862.1345 | Drink, Glucose Tolerance | MRV | |
| 862.1350 | Continuous Glucose Monitor Secondary Display | PJT | |
| 862.1445 | Chromatographic Separation, Lactate Dehydrogenase Isoenzymes | CEX | |
| 862.1445 | Electrophoretic, Lactate Dehydrogenase Isoenzymes | CFE | |
| 862.1445 | Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes | JGF | |
| 862.1509 | System, Test, Urinary Methylmalonic Acid | LPT | |
| 862.1685 | Radioimmunoassay, Thyroxine-Binding Globulin | CEE | |
| 862.1700 | Radioimmunoassay, Total Thyroxine | CDX | |
| 862.1700 | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | KLI | |
| 862.2265 | High Throughput DNA Sequence Analyzer | PFF | |
| 862.2570 | Instrumentation For Clinical Multiplex Test Systems | NSU | |
| 862.2570 | Real Time Nucleic Acid Amplification System | OOI | |
| 862.2570 | Mass Spectrometer For Clinical Multiplex Test Systems | OTA | |
| 862.2570 | Micro Total Analysis Instrument System | OUE | |
| 862.2570 | Complete Gene Expression Profiling Accessory Reagents | OVA | |
| 862.2570 | DNA Genetic Analyzer | PCA | |
| 862.2570 | Data Acquisition Software | PQQ | |
| 862.3100 | Enzyme Immunoassay, Amphetamine | DKZ | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3100 | Radioimmunoassay, Amphetamine | DJP | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3100 | Thin Layer Chromatography, Amphetamine | DIT | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3100 | Gas Chromatography, Amphetamine | DOD | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3100 | Liquid Chromatography, Amphetamine | DNI | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3150 | Enzyme Immunoassay, Barbiturate | DJL | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3150 | Enzyme Immunoassay, Barbiturate | DIS | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3150 | Radioimmunoassay, Barbiturate | DKN | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3150 | Thin Layer Chromatography, Barbiturate | DKX | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3150 | Mercury Dithiazone, Colorimetry, Barbiturate | DJN | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3150 | Hemagglutination Inhibition, Barbiturate | DLX | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3150 | Gas Liquid Chromatography, Barbiturate | DMF | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3150 | High Pressure Liquid Chromatography, Barbiturate | KZY | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3170 | Enzyme Immunoassay, Benzodiazepine | JXM | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3170 | High Pressure Liquid Chromatography, Benzodiazepine | LAA | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3170 | Test, Benzodiazepine, Over The Counter | NFV | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3170 | Gas Chromatography, Benzodiazepine | KZZ | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3170 | Thin Layer Chromatography, Benzodiazepine | LAB | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3200 | Calibrators, Drug Mixture | DKB | |
| 862.3200 | Calibrators, Drug Specific | DLJ | |
| 862.3200 | Calibrators, Ethyl Alcohol | DNN | |
| 862.3250 | Enzyme Immunoassay, Cocaine and Cocaine Metabolites | DIO | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3250 | Radioimmunoassay, Cocaine Metabolite | KLN | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3250 | Enzyme Immunoassay, Cocaine | JXO | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3250 | Hemagglutination, Cocaine Metabolites (Benzoylecgonine) | DLN | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3250 | Thin Layer Chromatography, Cocaine | DMN | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3250 | Free Radical Assay, Cocaine | DIR | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3250 | Gas Chromatography, Cocaine | DIN | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3250 | Thin Layer Chromatography, Benzoylecgonine | DOM | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3250 | High Pressure Liquid Chromatography, Cocaine and Cocaine Metabolites | LAC | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3270 | High Pressure Liquid Chromatography, Codeine | LAE | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3270 | Thin Layer Chromatography, Codeine | DLD | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3270 | Gas Chromatography, Codeine | LAD | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3580 | Radioimmunoassay, LSD (125-I) | DLB | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3580 | Free Radical Assay, LSD | DOL | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3610 | Gas Chromatography, Methamphetamine | LAF | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3610 | Thin Layer Chromatography, Methamphetamine | DJC | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3610 | High Pressure Liquid Chromatography, Methamphetamine | LAG | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3610 | Test, Methamphetamine, Over The Counter | NGG | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3620 | Enzyme Immunoassay, Methadone | DJR | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3620 | Hemagglutination Inhibition, Methadone | DIW | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3620 | Gas Chromatography, Methadone | DMB | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3620 | Thin Layer Chromatography, Methadone | DKR | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3620 | Liquid Chromatography, Methadone | DNT | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3620 | Free Radical Assay, Methadone | DPP | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3630 | Radioimmunoassay, Methaqualone | KXS | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3640 | Thin Layer Chromatography, Morphine | DNK | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3640 | Radioimmunoassay, Morphine (123-I), Goat Antibody Ammonium Sulfate Sep. | DOE | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3640 | Fluorometry, Morphine | DJJ | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3640 | Liquid Chromatography, Morphine | DPK | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3640 | Gas Chromatography, Morphine | DMY | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3640 | Hemagglutination Inhibition, Morphine | DLR | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3640 | Free Radical Assay, Morphine | DOK | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3640 | Radioimmunoassay, Morphine (3-H), Goat Antibody Ammonium Sulfate Sep. | DIQ | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3640 | Radioimmunoassay, Morphine-Barbiturate (125-I), Goat Antibody | DNA | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3650 | Enzyme Immunoassay, Opiates | DJG | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3650 | Gas Chromatography, Opiates | DJF | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3650 | Hemagglutination, Opiates | DLT | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3650 | Thin Layer Chromatography, Opiates | LAI | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3650 | Free Radical Assay, Opiates | DKT | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3650 | High Pressure Liquid Chromatography, Opiates | LAH | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3700 | Enzyme Immunoassay, Propoxyphene | JXN | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3700 | Thin Layer Chromatography, Propoxyphene | DPN | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3700 | Gas Chromatography, Propoxyphene | LAJ | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3700 | High Pressure Liquid Chromatography, Propoxyphene | LAK | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3870 | Enzyme Immunoassay, Cannabinoids | LDJ | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3870 | Reagents, Test, Tetrahydrocannabinol | DKE | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3870 | Radioimmunoassay, Cannabinoid(S) | LAT | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3910 | High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs | LFI | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3910 | U.V. Spectrometry, Tricyclic Antidepressant Drugs | LFH | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 862.3910 | Thin Layer Chromatography, Tricyclic Antidepressant Drugs | MLK | Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (
programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). |
| 864.5400 | Fibrometer | GIE | |
| 864.5400 | Timer, Coagulation | JBT | |
| 864.5425 | Control, Plasma, Abnormal | GGC | |
| 864.5425 | Plasma, Coagulation Control | GGN | |
| 864.5425 | Plasma, Control, Normal | GIZ | |
| 864.6550 | Control, Fecal Occult Blood | OSL | |
| 864.6650 | Study, Platelet Adhesive | JBZ | |
| 864.7275 | Test, Euglobulin Lysis | JBO | |
| 864.7300 | Fibrin Monomer Paracoagulation | JBN | |
| 864.7340 | Fibrinogen Standard | GFX | |
| 864.7340 | Plasma, Fibrinogen Control | GIL | |
| 864.7375 | Glutathione, Red-Cell | GII | |
| 864.7375 | Fluorescence, Visual Observation (Qual., U.V.), Glutathione Reductase | JMH | |
| 864.7375 | Assay, Glutathione Reductase | KQF | |
| 864.7415 | Control, Hemoglobin, Abnormal | JCM | |
| 864.7455 | Stain, Fetal Hemoglobin | GHQ | |
| 864.7500 | Acid Hematin | GGF | |
| 864.7720 | Test, Prothrombin Consumption | GGQ | |
| 864.7735 | Prothrombin-Proconvertin and Thrombotest | JPF | |
| 864.8150 | Calibrator for Cell Indices | KRX | |
| 864.8165 | Calibrator for Hemoglobin and Hematocrit Measurement | KRZ | |
| 864.8175 | Calibrator for Platelet Counting | KRY | |
| 864.8185 | Calibrator for Red-Cell and White-Cell Counting | KSA | |
| 864.8625 | Standards and Controls, Hemoglobin, Normal and Abnormal | GFS | |
| 864.8625 | Control, White-Cell | GGL | |
| 864.8625 | Control, Hemoglobin | GGM | |
| 864.8625 | Control, Platelet | GJP | |
| 864.8625 | Control, Red-Cell | GJR | |
| 864.8625 | Control, Hematocrit | GLK | |
| 864.8625 | Mixture, Control, White-Cell and Red-Cell Indices | GLQ | |
| 864.8625 | Control, Cell Counter, Normal and Abnormal | JCN | |
| 864.8625 | Mixture, Hematology Quality Control | JPK | |
| 864.8625 | Material, Quality Control, Semen Analysis | NRF | |
| 864.8625 | Control Material, Blood Circulating Epithelial Cancer Cell | NRS | |
| 864.9400 | Solution, Stabilized Enzyme | KSK | |
| 866.3395 | Norovirus Serological Reagents | OUC | |
| 866.5210 | Immunochemical, Ceruloplasmin | CHN | |
| 866.5210 | Ceruloplasmin, Rhodamine, Antigen, Antiserum, Control | DCT | |
| 866.5210 | Ceruloplasmin, FITC, Antigen, Antiserum, Control | DCY | |
| 866.5210 | Ceruloplasmin, Antigen, Antiserum, Control | DDB | |
| 866.5210 | P-Phenyl-Enediamine/EDTA (Spectrophotometric), Ceruloplasmin | JFQ | |
| 866.5210 | Indirect Copper Assay, Ceruloplasmin | JFR | |
| 866.5470 | Hemoglobin, Chain Specific, Antigen, Antiserum, Control | DAM | |
| 866.5620 | -2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control | DDT | |
| 866.5620 | -2-Macroglobulin, FITC, Antigen, Antiserum, Control | DDY | |
| 866.5620 | -2-Macroglobulin, Antigen, Antiserum, Control | DEB | |
| 866.5630 | System, Test,
-2-Microglobulin Immunological | JZG | |
| 866.5750 | System, Test, Radioallergosorbent (RAST) Immunological | DHB | Exemption is limited to devices classified under 21 CFR 866.5750 that are intended to detect any of the allergens included in table 2 of this document. |
| 866.5910 | Quality Control Material, Genetics, DNA | NZB | |
| 868.1040 | Algesimeter, Powered | BSI | |
| 868.1400 | Legging, Compression, Non-Inflatable | LLK | |
| 868.2385 | Analyzer, Nitrogen Dioxide | MRQ | Exemption is limited to standalone nitrogen dioxide analyzers and not those that are components of nitric oxide delivery systems intended to monitor nitrogen dioxide levels during inhaled nitric oxide therapy. |
| 868.2500 | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | KLK | |
| 868.2500 | Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia | LPP | |
| 868.2550 | Pneumotachometer | JAX | |
| 868.5180 | Bed, Rocking, Breathing Assist | CCO | |
| 868.6250 | Compressor, Air, Portable | BTI | |
| 870.1330 | Wire, Guide, Catheter | DQX | Exemption is limited to accessory torque devices that are manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires. |
| 870.1390 | Trocar | DRC | |
| 870.1650 | Syringe, Balloon Inflation | MAV | Exemption is limited to non-patient contacting balloon inflation syringes intended only to inflate/deflate balloon catheters and monitor pressure within the balloon. |
| 870.1875 | Lung Sound Monitor | OCR | |
| 870.2675 | Oscillometer | DRZ | |
| 870.2770 | Analyzer, Body Composition | MNW | Exemption is limited to body composition analyzers which are not intended to diagnose or treat any medical condition. |
| 870.4280 | Filter, Prebypass, Cardiopulmonary Bypass | KRJ | |
| 870.4290 | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | |
| 870.4340 | Monitor and/or Control, Level Sensing, Cardiopulmonary Bypass | DTW | |
| 870.4400 | Reservoir, Blood, Cardiopulmonary Bypass | DTN | Exemption is limited to cardiopulmonary bypass blood reservoirs that do not contain defoamers or blood filters. |
| 870.4420 | Sucker, Cardiotomy Return, Cardiopulmonary Bypass | DTS | |
| 870.4430 | Suction Control, Intracardiac, Cardiopulmonary Bypass | DWD | |
| 872.1720 | Tester, Pulp | EAT | |
| 872.3260 | External Cleaning Solution | PME | |
| 872.3300 | Coating, Denture Hydrophilic, Resin | EBE | |
| 872.3540 | Pad, Denture, Over The Counter | EHR | |
| 872.3540 | Cushion, Denture, Over The Counter | EHS | |
| 872.3560 | Reliner, Denture, Over The Counter | EBP | |
| 872.3590 | Denture, Plastic, Tooth | ELM | |
| 872.3600 | Denture Preformed (Partially Prefabricated Denture) | EKO | |
| 872.3890 | Splint, Endodontic Stabilizing | ELS | |
| 872.5550 | Ring, Teething, Fluid-Filled | KKO | |
| 872.6770 | Syringe, Cartridge | EJI | |
| 874.1090 | Tester, Auditory Impedance | ETY | Exemption is limited to auditory impedance testers that are in compliance with FDA-recognized consensus standard ANSI S3.39. |
| 874.1090 | Tympanometer | NAS | Exemption is limited to tympanometers that are in compliance with FDA-recognized consensus standard ANSI S3.39. |
| 874.1120 | Generator, Electronic Noise (for Audiometric Testing) | ETS | |
| 874.1325 | Electroglottograph | KLX | |
| 874.3310 | Calibrator, Hearing Aid/Earphone and Analysis Systems | ETW | |
| 874.3320 | Hearing Aid, Group and Auditory Trainer | EPF | |
| 874.3320 | Device, Assistive Listening | LZI | |
| 874.3330 | Hearing Aid, Master | KHL | |
| 874.3430 | Mold, Middle-Ear | ETC | |
| 874.3730 | Device, Voice Amplification | MCK | |
| 876.1500 | Endoscopic Magnetic Retriever | FCC | Exemption is limited to endoscopic magnetic retrievers intended for single use. |
| 876.1500 | Light Source, Incandescent, Diagnostic | FCQ | |
| 876.1500 | Light Source, Photographic, Fiberoptic | FCR | |
| 876.1500 | Light Source, Fiberoptic, Routine | FCW | |
| 876.1500 | Carrier, Sponge, Endoscopic | FGS | |
| 876.1500 | Light Source, Endoscope, Xenon Arc | GCT | |
| 876.1500 | Transformer, Endoscope | GCW | |
| 876.1500 | Scissors For Cystoscope | KGD | Exemption is limited to sterile scissors for cystoscope intended for single use. |
| 876.1500 | LED Light Source | NTN | |
| 876.1500 | Endoscopic Guide Wire, Gastroenterology-Urology | OCY | |
| 876.1500 | Endoscopic Grasping/Cutting Instrument, Non-Powered | OCZ | Exemption is limited to disposable, non-powered endoscopic grasping/cutting instruments intended for single use. |
| 876.4020 | Light, Catheter, Fiberoptic, Glass, Ureteral | FCS | |
| 876.4270 | Rod, Colostomy | EZP | |
| 876.4400 | Ligator, Hemorrhoidal | FHN | |
| 876.4400 | Ligator, Esophageal | MND | |
| 876.4500 | Lithotriptor, Biliary Mechanical | LQC | |
| 876.4770 | Urethrotome | EZO | |
| 876.5010 | Bag, Bile Collecting | EXF | |
| 876.5010 | Catheter, Biliary, Surgical | GCA | Exemption is limited to surgical biliary catheters that do not include a balloon component. |
| 876.5025 | Vibrator for Climax Control of Premature Ejaculation | PIA | |
| 876.5365 | Dilator, Esophageal (Metal Olive) Gastro-Urology | EZM | |
| 876.5365 | Bougie, Esophageal, and Gastrointestinal, Gastro-Urology | FAT | |
| 876.5365 | Dilator, Esophageal | KNQ | |
| 876.5520 | Dilator, Urethral | KOE | |
| 876.5630 | Catheter, Peritoneal, Long-Term Indwelling | FJS | Exemption is limited to non-patient contacting catheter finger grips intended for single use. |
| 876.5630 | Catheter, Peritoneal Dialysis, Single Use | FKO | Exemption is limited to non-patient contacting catheter finger grips intended for single use. |
| 876.5630 | System, Peritoneal, Automatic Delivery | FKX | Exemption is limited to continuous ambulatory peritoneal dialysis (CAPD) belts and catheter stands that do not include weigh scales. |
| 876.5665 | Disinfectant, Subsystem, Water Purification | NIH | |
| 876.5820 | Set, Dialyzer Holder | FKI | |
| 876.5895 | Irrigator, Ostomy | EXD | |
| 876.5980 | Catheter, Retention, Barium Enema With Bag | FGD | |
| 876.5980 | Gastrostomy Tube Holder | PLI | |
| 878.4370 | Drape, Surgical, ENT | ERY | |
| 878.4370 | Drape, Pure Latex Sheet, With Self-Retaining Finger Cot | EYX | |
| 878.4370 | Drape, Urological, Disposable | EYY | |
| 878.4370 | Pad, Kelly | FNW | |
| 878.4370 | Drape, Patient, Ophthalmic | HMT | |
| 878.4370 | Drape, Microscope, Ophthalmic | HMW | |
| 878.4370 | Ring (Wound Protector), Drape Retention, Internal | KGW | |
| 878.4370 | Drape, Surgical | KKX | Exemption is limited to surgical drapes that do not include an antimicrobial agent. |
| 878.4495 | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | GAQ | Exemption is limited to steel monofilament sutures that are uncoated and do not incorporate barbs. |
| 878.4580 | Lamp, Operating-Room | FQP | |
| 878.4580 | Light, Surgical, Instrument | FSQ | |
| 878.4580 | Light, Surgical, Floor Standing | FSS | |
| 878.4580 | Light, Surgical, Endoscopic | FSW | |
| 878.4580 | Light, Surgical, Connector | FSX | |
| 878.4580 | Light, Surgical, Ceiling Mounted | FSY | |
| 878.4580 | Light, Surgical, Carrier | FSZ | |
| 878.4580 | Light, Surgical, Accessories | FTA | |
| 878.4580 | Lamp, Surgical | FTD | |
| 878.4580 | Illuminator, Remote | FTG | |
| 878.4580 | Lamp, Surgical, Incandescent | GBC | |
| 878.5070 | Apparatus, Air Handling, Bench | FZG | |
| 878.5070 | Apparatus, Air Handling, Room | FZH | |
| 878.5070 | Apparatus, Air Handling, Enclosure | FZI | |
| 880.5580 | Locator, Acupuncture Point | BWJ | |
| 880.5580 | Needle, Acupuncture, Single Use | MQX | |
| 880.5780 | Stocking, Medical Support (to Prevent Pooling of Blood in Legs) | DWL | |
| 882.1020 | Analyzer, Rigidity | GZM | |
| 882.1470 | Computerized Cognitive Assessment Aid | PKQ | Exemption is limited to computerized cognitive assessment aids that are not intended for diagnostic assessment of specific diseases or conditions and rely on inputs from visual cues, auditory cues, and/or functional use of the hand. |
| 882.1540 | Device, Galvanic Skin Response Measurement | GZO | |
| 882.1560 | Device, Skin Potential Measurement | HCJ | |
| 882.1855 | Encephalogram Telemetry System | GYE | |
| 882.5895 | Vibratory Counter-Stimulation | OVP | |
| 884.1630 | Colposcope (and Colpomicroscope) | HEX | Exemption is limited to standard colposcopes (and colpomicroscopes) that use only a white light source, do not use filters other than a green filter, do not include image analysis software, and are not smartphone-based. |
| 884.2990 | Sheet, Recording, Breast Examination | NHM | |
| 884.3200 | Drain, Cervical | HFL | |
| 884.4400 | Forceps, Obstetrical | HDA | |
| 884.4530 | Tenaculum, Uterine | HDC | Exemption is limited to sterile urterine tenaculum devices that do not use suction and are intended for single use. |
| 884.4530 | Clamp, Umbilical | HFW | |
| 884.4530 | Speculum, Vaginal, Nonmetal | HIB | |
| 884.4530 | Speculum, Vaginal, Nonmetal, Fiberoptic | HIC | |
| 884.4530 | Clamp and Cutter, Umbilical | NBZ | |
| 884.4900 | Table, Obstetrical, AC-Powered (and Accessories) | HDD | |
| 884.4900 | Table, Obstetrical, Manual (and Accessories) | HHP | |
| 884.4900 | Table, Obstetric (and Accessories) | KNC | |
| 884.5200 | Hemorrhoid Prevention Pressure Wedge | OOA | |
| 884.5390 | Heater, Perineal, Direct Contact | HGZ | |
| 884.5390 | Heater, Perineal, Radiant, Non-Contact | HHA | |
| 884.5390 | Heater, Perineal | KND | |
| 884.5400 | Cup, Menstrual | HHE | |
| 884.5425 | Pad, Menstrual, Scented | HHL | |
| 884.6120 | Accessory, Assisted Reproduction | MQG | Exemption is limited to single embryo incubators with temperature, gas, and humidity control only; syringe pumps; collection tube warmers; dish/plate/microscope stage warmers; and controlled-rate cryopreservation freezers. |
| 884.6130 | Microtools, Assisted Reproduction (Pipettes) | MQH | Exemption is limited to assisted reproduction microtools (pipettes) manufactured from glass. |
| 884.6150 | Micromanipulators and Microinjectors, Assisted Reproduction | MQJ | |
| 884.6160 | Labware, Assisted Reproduction | MQK | Exemption is limited to dishes and plates that are intended for general assisted reproduction technology procedures. |
| 886.1120 | Photorefractor | MMF | |
| 886.1120 | Camera, Ophthalmic, General-Use | PJZ | |
| 886.1250 | Euthyscope, AC-Powered | HMK | |
| 886.1570 | Ophthalmoscope, AC-Powered | HLI | |
| 886.1570 | Ophthalmoscope, Battery-Powered | HLJ | |
| 886.1570 | Ophthalmoscopes, Replacement Batteries, Hand-Held | MSG | |
| 886.1780 | Retinoscope, AC-Powered | HKL | |
| 886.1850 | Biomicroscope, Slit-Lamp, AC-Powered | HJO | Exemption is limited to slit-lamp, AC-powered biomicroscopes intended only for the visual examination of the anterior segment of the eye, are classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, do not provide any quantitative output, and are not intended for screening or automated diagnostic indications. |
| 886.1945 | Transilluminator, AC-Powered | HJM | |
| 886.3320 | Ocular Peg | MQU | Exemption is limited to ocular pegs supplied sterile. |
| 886.4150 | Tubing, Replacement, Phacofragmentation Unit | MSR | |
| 886.4250 | Unit, Electrolysis, AC-Powered, Ophthalmic | HRO | |
| 886.4335 | Headlight, Fiberoptic Focusing | FCT | |
| 886.4335 | Light, Headband, Surgical | FSR | |
| 886.4335 | Headlamp, Operating, AC-Powered | HPQ | |
| 886.4400 | Locator, Metal, Electronic | HPM | |
| 886.4440 | Magnet, AC-Powered | HPO | |
| 886.4790 | Sponge, Ophthalmic | HOZ | |
| 886.4790 | Eye Tray | OJK | |
| 888.1240 | Dynamometer, AC-Powered | LBB | |
| 888.4580 | Instrument, Surgical, Sonic and Accessory/Attachment | JDX | |
| 888.4580 | System, Cement Removal Extraction | LZV | |
| 890.1450 | Hammer, Reflex, Powered | IKO | |
| 890.5100 | Bath, Hydro-Massage | ILJ | |
| 890.5100 | Bath, Sitz, Powered | ILM | |
| 890.5110 | Bath, Paraffin | IMC | |
| 890.5250 | Cabinet, Moist Steam | IMB | |
| 890.5360 | Exerciser, Measuring | ISD | |
| 890.5500 | Lamp, Infrared, Therapeutic Heating | ILY | |
| 890.5575 | Device, Warning, Overload, External Limb, Powered | IRN | |
| 892.1000 | MRI Disposable Kit | OIM | |
| 892.1560 | Biopsy Needle Guide Kit | OIJ | |
| 892.1610 | Aperature, Radiographic | IZS | |
| 892.1610 | Cone, Radiographic | IZT | |
| 892.1610 | Collimator, Automatic, Radiographic | IZW | |
| 892.1610 | Collimator, Manual, Radiographic | IZX | |
| 892.1610 | Device, Beam Limiting, X-Ray, Diagnostic | KPW | |
| 892.1650 | Arthrogram Tray | OII | |
| 892.1650 | Radiology Dental Tray | OIK | |
| 892.1670 | Device, Spot-Film | IXL | |
| 892.1680 | Radiographic Contrast Tray | OIO | |
| 892.1680 | Radiology Diagnostic Kit | OIP | |
| 892.1730 | Discography Kit | OIL | |
| 892.1820 | Chair, Pneumocephalographic | HBK | |
| 892.1850 | Cassette, Radiographic Film | IXA | |
| 892.1860 | Changer, Radiographic Film/Cassette | KPX | |
| 892.1870 | Programmer, Changer, Film/Cassette, Radiographic | IZP | |
| 892.1900 | Controller, Temperature, Radiographic | EGT | |
| 892.1900 | Dryer, Film, Radiographic | EGW | |
| 892.1900 | Processor, Radiographic-Film, Automatic, Dental | EGY | |
| 892.1900 | Processor, Radiographic-Film, Automatic | IXW | |
| 892.1900 | Processor, Cine Film | IXX | |
| 892.2030 | Digitizer, Image, Radiological | LMA | |
| 892.2030 | Digitizer, Images, Ophthalmic | NFH | |
| 892.2040 | Camera, Multi Format, Radiological | LMC | |
| 892.2040 | Device, Hardcopy, Images, Ophthalmic | NFI | |
| 892.5730 | Prostate Seeding Kit | OIN | |
In table 1, FDA included devices classified under § 866.5750 (Radioallergosorbent (RAST) immunological test system, product code “DHB”). FDA does not believe that all devices with the product code DHB meet the exemption criteria from premarket notification requirements. However, FDA is identifying a substantial amount of these devices for exemption in table 2.
| Allergen code | Allergen product | Source |
| --- | --- | --- |
| | | |
| g1 | Sweet vernal grass | . |
| g3 | Cocksfoot grass, Orchard grass | . |
| g4 | Meadow fescue | . |
| g5 | Rye-grass (perennial rye grass) | . |
| g7 | Common reed (common reed grass) | . |
| g8 | Meadow grass, Kentucky blue (June grass) | . |
| g9 | Redtop, Bentgrass | ,
(
). |
| g11 | Brome grass | . |
| g12 | Cultivated rye (cultivated rye grass) | . |
| g13 | Velvet grass | . |
| g14 | Cultivated oat (cultivated oat grass) | . |
| g15 | Cultivated wheat (cultivated wheat grass) | (
spp.). |
| g16 | Meadow foxtail (meadow foxtail grass) | . |
| g17 | Bahia grass | . |
| g24 | Wheat grass, Western | (
). |
| g30 | Bluegrass, annual | . |
| g70 | Wild rye grass | ,
. |
| g71 | Canary grass | . |
| g201 | Barley, cultivated | . |
| g202 | Maize, corn (cultivated corn) | . |
| g203 | Salt grass | . |
| g204 | False oat-grass | . |
| g216 | Cyn d 1 | . |
| g701 | Phl p 1.0102, Phl p 5.0101 | . |
| g702 | Phl p 7.0101 | . |
| g703 | Phl p 12.0101 | . |
| | | |
| w2 | Western ragweed | . |
| w4 | False ragweed | (
). |
| w5 | Wormwood | ,
. |
| w6 | Mugwort | . |
| w7 | Marguerite, ox-eye daisy | . |
| w8 | Dandelion | ,
. |
| w9 | Plantain (English), Ribwort | . |
| w10 | Goosefoot, lamb's quarters | . |
| w11 | Saltwort (prickly), Russian thistle | (
). |
| w12 | Goldenrod | (
spp.). |
| w13 | Cocklebur, common | . |
| w14 | Common pigweed (rough pigweed) | . |
| w15 | Scale, Lenscale | . |
| w16 | Rough marsh elder | ,
. |
| w17 | Firebush (Kochia) | . |
| w18 | Sheep sorrel | . |
| w19 | Wall pellitory | . |
| w20 | Nettle (Common stinging nettle) | . |
| w21 | Wall pellitory | . |
| w22 | Japanese hop (careless weed) | (
). |
| w23 | Yellow dock, Yellow dockweed | . |
| w24 | Spiny pigweed | . |
| w27 | Carnation | spp. |
| w28 | Rose | . |
| w33 | Clover | . |
| w35 | Mexican tea | . |
| w36 | Rabbit bush | (
). |
| w37 | Salt bush, annual | . |
| w39 | Water hemp, Western | (
). |
| w41 | Burrobrush | . |
| w42 | Poverty weed | |
| w43 | Common sagebrush | . |
| w45 | Alfalfa | . |
| w46 | Dog fennel | . |
| w53 | Geranium | |
| w67 | Groundsel bush | . |
| w69 | Iodine bush | . |
| w70 | Ragweed, slender | . |
| w75 | Wing scale (wingscale) | . |
| w82 | Careless weed | ,
. |
| w90 | Japanese hop | (
). |
| w203 | Rape (rape pollen) | . |
| w204 | Sunflower | . |
| w206 | Camomile | . |
| w207 | Lupin | spp. |
| w210 | Sugar-beet | . |
| w211 | Par j 2.0101 | . |
| w231 | Art v 1 | (Mugwort). |
| w232 | Sal k 1 | . |
| w233 | Art v 3 | (LTP, Mugwort). |
| w234 | Pla l 1 | . |
| w235 | Che a 1.0101 | . |
| w236 | Mer a 1.0101 | . |
| a753 | Art v 1 | (Mugwort weed). |
| | | |
| t1 | Box-elder (Maple) | ,
. |
| t2 | Gray alder, speckled alder (alder) | . |
| t4 | Hazel, hazelnut | ,
. |
| t5 | American beech (beech) | (
). |
| t6 | Mountain juniper, Mountain cedar | (
). |
| t8 | Elm | . |
| t9 | Olive | . |
| t10 | Walnut | ,
. |
| t11 | Maple leaf sycamore, London plane, Plane tree | . |
| t61 | Sycamore | . |
| t12 | Willow | ,
. |
| t14 | Cottonwood (Eastern Cottonwood/Black Cottonwood) | . |
| t15 | White ash | . |
| t16 | White pine | . |
| t18 | Eucalyptus, gum-tree | (
spp.). |
| t19/t26 | Acacia | (
spp.). |
| t20 | Mesquite | |
| t21 | Melaleuca, cajeput tree | (
). |
| t22 | Pecan, hickory | (
). |
| t23 | Italian/Mediterranean/funeral cypress | . |
| t24 | Japanese cypress | (
spp.). |
| t25 | Ash | . |
| t27 | Maple, red | . |
| t29 | Acacia | spp. |
| t30 | Birch, white | . |
| t32 | Willow, black | . |
| t33 | Ash, Arizona | . |
| t35 | Cedar, salt | . |
| t37 | Bald cypress (white bald cypress) | . |
| t38 | Elm, Chinese/Siberian | . |
| t40 | Hazelnut tree | . |
| t41 | White hickory | (
). |
| t42 | Oak, red | . |
| t43 | Loblolly pine | . |
| t44 | Hackberry | . |
| t45 | Cedar elm | . |
| t47 | Juniper, one seed | . |
| t48 | Pine, lodgepole | . |
| t49 | Pine, ponderosa | . |
| t50 | Beech, European | . |
| t51 | Tree of Heaven | . |
| t52 | Western white pine | . |
| t54 | Russian olive | . |
| t55 | Scotch broom | . |
| t56 | Bayberry | . |
| t57 | Red cedar | . |
| t60 | Western juniper | . |
| t61 | Sycamore | . |
| t70 | Mulberry (white mulberry) | . |
| t71 | Red mulberry | . |
| t72 | Queen palm | . |
| t73 | Australian pine | . |
| t77 | Oak mix (red, white, black) | spp. |
| t80 | Japanese cypress | . |
| t81 | Japanese alder | . |
| t83 | Mango tree | . |
| t90 | Walnut, black | . |
| t96 | Poplar, white (poplar) | . |
| t103/t218 | Virginia live oak (live oak) | . |
| t105 | Pepper tree | . |
| t110 | Orange tree | . |
| t201 | Spruce, Norway spruce | (
). |
| t202 | Alder, smooth | spp.
(
). |
| t203 | Horse chestnut | . |
| t205 | Elder | . |
| t206 | Chestnut | . |
| t207 | Douglas fir | (
). |
| t208 | Linden | . |
| t209 | Horn beam | . |
| t210 | Privet | . |
| t211 | Sweet gum | . |
| t212 | Cedar | . |
| t213 | Pine | . |
| t214 | Date palm | . |
| t215 | Lilac | . |
| t217 | Pepper tree | . |
| t217 | Red alder | . |
| t218 | Virginia live oak | . |
| t218 | Bayberry (bayberry/sweet gale) | . |
| t219 | Palo verde | . |
| t219 | Red cedar | . |
| t220 | Bet v 4 | (Birch). |
| t221 | Bet v 2.0101, Bet v 4 | (Birch). |
| t222 | Cypress (Arizona cypress) | . |
| t223 | Oil palm | . |
| t224 | Ole e 1 | . |
| t225 | Bet v 6 | (Birch). |
| t226 | Cup a 1 | . |
| t227 | Ole e 7 | . |
| t228 | Aspen, quaking | . |
| t229 | Eastern hemlock | . |
| t230 | Redwood (sequoia) | . |
| t232 | Pussy willow | . |
| t240 | Ole e 9.0101 | . |
| t241 | Pla a 1.0101 | . |
| t242 | Pla a 2 | . |
| t243 | Pla a 3.0101 | . |
| t244 | Cor a 1.0103 | . |
| t245 | Aln g 1.0101 | . |
| t246 | Cry j 1 | . |
| t280 | Locust tree | . |
| t401 | Brazilian peppertree | . |
| t402 | Mastic tree | . |
| t404 | Tree of heaven | . |
| t406 | Date palm | . |
| a482 | Ole e 1 | (Olive Oil). |
| | | |
| d207 | Blo t 5.0101 | . |
| d208 | Lep d 2.0101 | . |
| Microorganisms, Molds, Yeast | | |
| m1 | (
) | (
). |
| m2 | (
) | (
). |
| m3 | | . |
| m4 | | . |
| m5 | | . |
| m7 | | . |
| m8 | (
) | (
). |
| m9 | (
) | (
). |
| m10 | | (
). |
| m11 | | . |
| m12 | | . |
| m13 | | . |
| m14 | | (
). |
| m15 | | . |
| m16 | | (K923044). |
| m17 | | . |
| m18 | | . |
| m19 | | . |
| m20 | | . |
| m21 | | . |
| m22 | | (
). |
| m23 | | . |
| m24 | | (
). |
| m24 | spp | spp. |
| m25 | | . |
| m25 | | . |
| m26 | | . |
| m26 | | . |
| m27 | spp | spp. |
| m29 | | . |
| m30 | | . |
| m32 | | . |
| m34 | | . |
| m36 | | . |
| m37 | | . |
| m40 | | . |
| m43 | | . |
| m44 | | . |
| m45 | | . |
| m46 | | . |
| m47 | | . |
| m48 | | . |
| m49 | | . |
| m50 | | (
). |
| m51 | | . |
| m53 | | (
). |
| m54 | | . |
| m63 | | . |
| m66 | | . |
| m67 | | . |
| m68 | | . |
| m69 | | (
). |
| m70 | (
) | (
). |
| m71 | | spp. |
| m72 | | . |
| m73 | | (
). |
| m80 | (
) | . |
| m80 | spp | spp. |
| m81 | (
) | . |
| m88 | | . |
| m93 | | . |
| m94 | | . |
| m201 | (
) (Barley smut) | (
). |
| m202 | (
) | (
). |
| m203 | | . |
| m204 | | . |
| m205 | | . |
| m207 | | . |
| m208 | | . |
| m209 | | (
). |
| m209 | | (
). |
| m210 | | . |
| m211 | | . |
| m211 | Oat smut | . |
| m212 | | (
). |
| m212 | | . |
| m213 | Bermuda grass smut | . |
| m214 | Johnson grass smut | . |
| m215 | Corn smut | . |
| m218 | Asp f 1.0101 | . |
| a3050 | Asp r 1 | . |
| m219 | Asp f 2 | . |
| m220 | Asp f 3.0101 | . |
| m221 | Asp f 4 | . |
| m222 | Asp f 6.0101 | . |
| m223 | (
) | . |
| m224 | (
) | . |
| m226 | (
) | . |
| m227 | spp. (
spp.) | spp. (
spp.). |
| m228 | . | |
| m229 | Alt a 1.0101 | (
). |
| m230 | Alt a 6.0101 | (
). |
| m231 | Cla h 8.0101 | (
). |
| m300 | spp. | spp. |
| m304 | | . |
| m305 | | . |
| m309 | | . |
| m310 | | . |
| m311 | | . |
| m312 | | . |
| | | |
| e6 | Guinea pig epithelium | . |
| e7 | Pigeon droppings | ,
. |
| e25 | Chicken serum | (
spp.). |
| e26 | Parrot serum | spp. |
| e62 | Camel | . |
| e70 | Goose feathers | . |
| e71 | Mouse epithelium | (
spp.). |
| e73 | Rat epithelium | . |
| e74 | Rat urine proteins | . |
| e75 | Rat serum proteins | . |
| e76 | Mouse serum proteins | (
spp.). |
| e77 | Budgerigar droppings | . |
| e78 | Budgerigar feathers | . |
| e79 | Budgerigar serum proteins | . |
| e80 | Goat epithelium | . |
| e81 | Sheep epithelium | (
spp.). |
| e82 | Rabbit epithelium | (
spp.). |
| e83 | Swine epithelium | (
spp.). |
| e84 | Hamster epithelium | . |
| e85 | Chicken feathers | (
spp.). |
| e86 | Duck feathers | . |
| e87 | Rat epithelium, serum proteins, and urine proteins | . |
| e88 | Mouse epithelium, serum proteins, and urine proteins (mouse) | (
spp.). |
| e89 | Turkey feathers | . |
| e90 | Budgerigar serum proteins, feathers, and droppings | . |
| e91 | Pigeon serum proteins, feathers, and droppings | spp. |
| e92 | Parrot serum proteins, feathers, and droppings | spp. |
| e93 | Pigeon serum proteins | . |
| e94 | Fel d 1.0101 | . |
| a345 | Fel d 1 | . |
| e98 | Parrot droppings | spp. |
| e101 | Can f 1.0101 | (
). |
| a174 | Can f 1 | (
). |
| e102 | Can f 2.0101 | (
). |
| e196 | Parakeet feathers | . |
| e197 | Parakeet droppings | . |
| e198 | Parakeet serum | . |
| e199 | Canary bird serum | . |
| e200 | Canary bird droppings | . |
| e201 | Canary bird feathers (Canary feathers) | . |
| e202 | Reindeer epithelium | . |
| e203 | Mink epithelium | spp. |
| e204 | Bos d 6 | (
spp.). |
| e205 | Horse, serum proteins | (
spp.). |
| e206 | Rabbit, serum proteins | (
spp.). |
| e208 | Chinchilla epithelium | . |
| e209 | Gerbil epithelium | . |
| e210 | Fox epithelium | . |
| e211 | Rabbit, urine proteins | (
spp.). |
| e212 | Swine, urine proteins | (
spp.). |
| e213 | Parrot feathers | spp. |
| e214 | Finch feathers | . |
| e215 | Pigeon feathers | (
spp.),
spp. |
| e216 | Deer epithelium | . |
| e217 | Ferret epithelium | . |
| e218 | Chicken droppings | (
spp.). |
| e219 | Chicken, serum proteins | (
spp.). |
| e220 | Fel d 2, Cat serum albumin | . |
| e221 | Can f 3 | (
) (Dog serum albumin). |
| e222 | Swine serum albumin (Sus s PSA) | (
spp.). |
| e225 | Lovebird feathers | . |
| e226 | Can f 5.0101 | . |
| e227 | Equ c 1.0101 | . |
| e228 | Fel d 4.0101 | . |
| e230 | Equ c 3 | . |
| e231 | Mus m 1 | . |
| | | |
| f9 | Rice | . |
| f12 | Pea (green pea) | . |
| f15 | White bean | . |
| f19 | Cayenne pepper | , (
). |
| f21 | Sugar cane | . |
| f22 | Raspberry | . |
| f26 | Pork | (
spp.). |
| f29 | Watermelon | (
). |
| f31 | Carrot | . |
| f32 | Oyster mushroom | . |
| f33 | Orange | . |
| f35 | Potato | . |
| f43 | Mother's milk | . |
| f44 | Strawberry | (
spp.). |
| f45 | Yeast, baker's | . |
| f46 | Pepper, Red | . |
| f47 | Garlic | . |
| f48 | Onion | . |
| f49 | Apple | (
spp.). |
| f51 | Bamboo shoot | . |
| f52 | Cacao/chocolate | . |
| f54 | Sweet potato | . |
| f55 | Common millet | . |
| f56 | Foxtail millet | . |
| f57 | Japanese millet | . |
| f58 | Pacific squid | . |
| f59 | Octopus | (
spp.). |
| f63 | Kefir | NA. |
| f67 | Parmesan cheese | NA. |
| f81 | Cheese, cheddar type | NA. |
| f82 | Cheese, mold type | NA. |
| f83 | Chicken | (
spp.). |
| f86 | Parsley | . |
| f87 | Melon | . |
| f88 | Mutton (lamb) | (
spp.). |
| f90 | Malt | . |
| f92 | Banana | spp. |
| f93 | Cacao | . |
| f94 | Pear | (
spp.). |
| f97 | Yam | spp.,
. |
| f97 | Chamomile tea | . |
| f98 | Gliadin | (
spp.). |
| f102 | Cantaloupe | . |
| f105 | Chocolate | . |
| f109 | Cottonseed | . |
| f110 | Giant radish | . |
| f118 | Zucchini | . |
| f119 | Radish | . |
| f120 | Venison | . |
| f121 | Pinto bean | . |
| f122 | Cheese, American | NA. |
| f127 | Black-eyed pea | . |
| f131 | Black Olive | . |
| f136 | Red beet | . |
| f139 | Goat's Cheese | . |
| f140 | Bran | NA. |
| f141 | Corn (vegetables) | . |
| f152 | Green bell pepper | . |
| f155 | Brewer's yeast | . |
| f157 | Duck | . |
| f158 | Goose | . |
| f160 | Camembert cheese | NA. |
| f162 | Nectarine | . |
| f163 | Kohlrabi | . |
| f65 | Perch | |
| f166 | Leek | . |
| f170 | Cheese (Switzerland) (Swiss cheese) | NA. |
| f174 | Fig | . |
| f177 | Cranberry | . |
| f179 | Raisin | spp. |
| f182 | Lima bean | . |
| f198 | Flaxseed (bruised grain) | . |
| f199 | Untreated native milk | (
spp.). |
| f208 | Lemon | . |
| f209 | Grapefruit | . |
| f210 | Pineapple | . |
| f211 | Blackberry | . |
| f212 | Mushroom (champignon) | (
spp.). |
| f213 | Rabbit | (
spp.). |
| f214 | Spinach | . |
| f215 | Lettuce | . |
| f216 | Cabbage | . |
| f217 | Brussels sprouts | . |
| f218 | Paprika, sweet pepper | . |
| f219 | Fennel seed | . |
| f219 | Sage | . |
| f220 | Cinnamon | spp. |
| f221 | Coffee | spp. |
| f222 | Tea | . |
| f223 | Green olive | . |
| f225 | Summer squash, pumpkin | . |
| f225 | Pumpkin | . |
| f226 | Pumpkin seed | . |
| f227 | Sugar-beet seed | . |
| f229 | Safflower Seed | . |
| f231 | Milk, boiled | (
spp.). |
| f234 | Vanilla | . |
| f237 | Apricot | . |
| f241 | Gouda cheese | NA. |
| f242 | Cherry | . |
| f244 | Cucumber | . |
| f246 | Guar, guar gum | . |
| f247 | Honey | NA. |
| f248 | Rosemary | . |
| f254 | Plaice | . |
| f255 | Plum | ,
. |
| f258 | Squid | spp. |
| f259 | Grape | (
spp.). |
| f260 | Broccoli | (
). |
| f261 | Asparagus | . |
| f262 | Aubergine, eggplant | . |
| f263 | Green pepper | ,
. |
| f264 | Eel | . |
| f265 | Caraway | . |
| f265 | Cumin | . |
| f266 | Mace | . |
| f267 | Cardamon | . |
| f268 | Clove | . |
| f269 | Basil | . |
| f270 | Ginger | . |
| f271 | Anise | . |
| f272 | Tarragon | . |
| f273 | Thyme | . |
| f274 | Marjoram | . |
| f275 | Lovage | . |
| f276 | Fennel, fresh | . |
| f277 | Dill | . |
| f278 | Bay leaf | . |
| f279 | Chili pepper | . |
| f280 | Black pepper | . |
| f281 | Curry (Santa Maria) | NA. |
| f282 | Nutmeg | . |
| f283 | Oregano | . |
| f284 | Turkey meat | . |
| f285 | Elk/moose meat | spp. |
| f286 | Mare's milk | (
spp.). |
| f287 | Red kidney bean | . |
| f288 | Blueberry | (
spp.). |
| f289 | Date | . |
| f291 | Cauliflower | . |
| f292 | Guava | . |
| f293 | Papaya | . |
| f294 | Passion fruit, Maracuja | (
spp.). |
| f295 | Carambola | . |
| f296 | Carob | . |
| f297 | Gum arabic | (
spp.). |
| f298 | Tragacanth | spp. |
| f299 | Sweet chestnut (chestnut) | . |
| f300 | Pinto bean | spp. |
| f301 | Persimmon (kaki fruit, sharon) | . |
| f302 | Mandarin (tangerine, clementine, satsumas) | . |
| f305 | Fenugreek | . |
| f306 | Lime | . |
| f307 | Hake | . |
| f308 | Sardine (pilchard) | . |
| f310 | Blue vetch | . |
| f311 | Megrim | . |
| f315 | Green bean | . |
| f316 | Rape seed | . |
| f317 | Coriander | . |
| f318 | Jack fruit | . |
| f319 | Beetroot | . |
| f320 | Crayfish | . |
| f321 | Horse meat | (
spp.). |
| f322 | Red currant | . |
| f324 | Hop (fruit cone) | . |
| f325 | Saffron | . |
| f328 | Fig | . |
| f329 | Watermelon | . |
| f330 | Rose hip | spp. |
| f331 | Saffron | . |
| f332 | Mint | . |
| f333 | Linseed | . |
| f336 | Jujube | . |
| f336 | Wine vinegar | (
spp.). |
| f337 | Sole | . |
| f337 | English sole | . |
| f338 | Wine, white | (
spp.). |
| f339 | Allspice | . |
| f339 | Wine, red | (
spp.). |
| f341 | Cranberry | ,
. |
| f342 | Olive (black, fresh) | . |
| f343 | Raspberry | . |
| f344 | Sage | . |
| f346 | Chives | . |
| f347 | Quinoa | . |
| f348 | Litchi | . |
| f349 | Chum salmon roe | . |
| f358 | Artichoke | . |
| f360 | Yogurt | NA. |
| f368 | Black bass | (
). |
| f374 | Karaya gum | . |
| f375 | Horseradish | . |
| f377 | Maple syrup | NA. |
| f379 | Okra | . |
| f382 | Beet, sugar | . |
| f401 | Loquat | . |
| f402 | Fig | . |
| f403 | Brewer's yeast | . |
| f405 | Mint | spp. |
| f406 | Arugula | . |
| | | |
| h1 | Greer Labs., Inc | NA. |
| h2 | Hollister-Stier Labs | NA. |
| h6 | Japan | NA. |
| | | |
| i7 | Midge | . |
| i8 | Moth | ,
spp. |
| i47 | Water flea | spp. |
| i49 | Deer fly | spp. |
| i51 | Black ant | . |
| i54 | Flea mix (dog/cat), common flea | spp. |
| i71 | Mosquito | ,
spp. and
spp. |
| i72 | Green nimitti | . |
| i73 | Blood worm | ,
,
spp. |
| i75 | European hornet | . |
| i76 | Berlin beetle | . |
| i77 | European paper wasp | . |
| i78 | Fly | . |
| i80 | Bumblebee | . |
| i201 | Horse bot fly | . |
| i202 | Grain weevil | . |
| i203 | Mediterranean flour moth | (
). |
| i204 | Horse fly | spp. |
| i205 | Bumblebee | . |
| i208 | Api m 1.0101 | . |
| a45 | Api m 1 | . |
| i209 | Ves v 5.0101 | . |
| a670 | Ves v 5 | . |
| i210 | Pol d 5.0101 | . |
| i211 | Ves v 1.0101 | . |
| i213 | Api m 4 | . |
| i214 | Api m 2 | . |
| i215 | Api m 3 | . |
| i216 | Api m 5 | . |
| i217 | Api m 10 | . |
| i220 | Bla g 1.0101 | . |
| i221 | Bla g 2.0101 | . |
| i222 | Bla g 5.0101 | . |
| i223 | Bla g 7 | . |
| a46 | Api m 2 | . |
| | | |
| o1 | Cotton, crude fibers | spp. |
| o3 | Cotton (treated) | spp. |
| o70 | Seminal fluid | . |
| o71 | | . |
| o72 | crude extract customer specific | . |
| o72 | Sperm-sediment | . |
| o73 | crude extr. vector customer specific | . |
| o74 | with vector customer specific | . |
| o201 | Tobacco leaf, tobacco dust | . |
| o202 | Artemia salina, fish feed | . |
| o203 | Tetramin, fish feed | . |
| o207 | Daphnia, fish feed | spp. |
| o211 | Mealworm | . |
| o212 | Streptavidin | . |
| o213 | MBP (maltose binding protein) | . |
| o214 | CCD; MUXF3 from bromelain | . |
| o72 | Enterotoxin A (Sta a SEA) | . |
| o73 | Enterotoxin B (Sta a SEB) | . |
| | | |
| p1 | Ascaris | . |
| p2 | Echinococcus | . |
| p3 | Schistosoma | . |
| p4 | Anisakis (Herring Worm) | (
spp.). |
| p5 | Toxocara canis | . |
| p10 | Ani s 3.0101 | (
spp.). |
| p11 | Ani s 1 | (
spp.). |
| | | |
| k4 | Threshing dust | NA. |
| k5 | Flax | NA. |
| k7 | Hay Dust | NA. |
| k8 | Hop (hops) | . |
| k12 | Grain mill dust | NA. |
| k14 | Kapok | NA. |
| k20 | Sheep's wool (treated) (wool) | (
spp.). |
| k21 | Sheep's wool (Untreated) | (
spp.). |
| k23 | Straw Dust | NA. |
| k33 | Oak | NA. |
| k70 | Green coffee bean | spp. |
| k71 | Castor bean | . |
| k72 | Ispaghula | . |
| k73 | Silk waste | NA. |
| k74 | Silk | . |
| k75 | Isocyanate TDI (Toluene diisocyanate) | NA. |
| k76 | Isocyanate MDI (Diphenylmethane diisocyanate) | NA. |
| k77 | Isocyanate HDI (Hexamethylen diisocyanate) | NA. |
| k78 | Ethylene oxide | NA. |
| k79 | Phthalic anhydride | NA. |
| k80 | Formaldehyde/Formalin | NA. |
| k81 | Ficus | (
spp.). |
| k83 | Cotton seed | . |
| k84 | Sunflower seed | . |
| k85 | Chloramin T | NA. |
| k86 | Trimellitic anhydride, TMA | NA. |
| k87 | Asp o 21, alpha-amylase | . |
| k89 | Orris root | . |
| k99 | HSA (Human Serum Albumin) (Hom s HSA) | . |
| k201 | Car p 1, Papain | . |
| k202 | Ana c 2, Bromelain | . |
| k204 | Maxatase | . |
| k205 | Alcalase | spp. |
| k206 | Savinase, Protease 1 (Bac l Subtilisin) | spp. |
| k208 | Gal d 4, Lysozyme | (
spp.). |
| k209 | Hexahydrophtalic anhydrid | NA. |
| k210 | Maleic anhydride | NA. |
| k211 | Methyltetrahydrophtalic anhydrid | NA. |
| k212 | Abachi wood dust | . |
| k213 | Pepsin (Sus s Pepsin) | (
spp.). |
| k213 | TCPA | NA. |
| k214 | Bougainvillea | spp. |
| k225 | Horse radish peroxidase (Arm r HRP) | . |
| k226 | Ascorbate oxidase (Cuc p ascorbate oxidase) | . |
| k301 | Flour dust | spp. |
| k501 | Savinase customer specific | Proprietary knowledge of customer. |
| k502 | Lipolase customer specific | Proprietary knowledge of customer. |
| k503 | Termamyl customer specific | Proprietary knowledge of customer. |
| k504 | Clazinase customer specific | Proprietary knowledge of customer. |
**V. Reference**
The following reference is on display in the Division of Dockets Management (see *ADDRESSES* ) and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at *https://www.regulations.gov.* FDA has verified the Web site address, as of the date this document publishes in the *Federal Register* , but Web sites are subject to change over time.
1. FDA Guidance, “Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff,” February 19, 1998, available at *http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf.*
Dated: March 8, 2017.
Leslie Kux,
Associate Commissioner for Policy.