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Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments A Notice by the Food and Drug Administration on 03/14/2017

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Printed version: PDF (http://www.gpo.gov/fdsys/pkg/FR-2017-03-14/pdf/2017-04938.pdf) Publication Date: 03/14/2017 (/documents/2017/03/14) Agencies: Food and Drug Administration (http://www.federalregister.gov/agencies/food-and-drug-administration) 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 http://www.regulations.gov (http://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. Comments Close: 05/15/2017 Document Type: Notice Document Citation: 82 FR 13609 Page: 13609-13632 (24 pages) Agency/Docket Number: Docket No. FDA-2017-N-1129 Document Number: 2017-04938

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ENHANCED CONTENT

Docket Number: FDA-2017-N-1129 (http://www.regulations.gov/docket?D=FDA-2017-N-1129) Public Comments: 46 comments (http://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2017-N-1129) Supporting/Related Materials: Attachment 9 Becker, E. High Resolution NMR (Third Edition)... (http://www.regulations.gov/document?D=FDA-2017-N-1129-0051) Attachment 8 Becker, E. A Brief History of Nuclear Magnetic... (http://www.regulations.gov/document?D=FDA-2017-N-1129-0050) Attachment 7 History of Bruker re: Comment from Bruker (http://www.regulations.gov/document?D=FDA-2017-N-1129-0049) Attachment 2 Beger et al Metabolomics enables precision... (http://www.regulations.gov/document?D=FDA-2017-N-1129-0048) Attachment 1 Improvement of Biological Product Quality by... (http://www.regulations.gov/document?D=FDA-2017-N-1129-0047) Reference 1 - Procedures for Class II Device Exemptions from... (http://www.regulations.gov/document?D=FDA-2017-N-1129-0002)

ENHANCED CONTENT PUBLISHED DOCUMENT

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 Start Printed Page 13610

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 http://www.regulations.gov (http://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: n Federal eRulemaking Portal: http://www.regulations.gov (http://www.regulations.gov). Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov (http://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 http://www.regulations.gov (http://www.regulations.gov). n 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: n 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. n 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

http://www.regulations.gov (http://www.regulations.gov) or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. n 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 http://www.regulations.gov (http://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 (/select-citation/2017/03/14/21-CFR-10.20) and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469 (/citation/80-FR-56469), September 18, 2015, or access the information at: http://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf (http://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 http://www.regulations.gov (http://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] (mailto:[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. 360 (http://api.fdsys.gov/link?collection=uscode&title=21&year=mostrecent§ion=360&type=usc&link-type=html)c), 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 (http://api.fdsys.gov/link?collection=uscode&title=21&year=mostrecent§ion=360&type=usc&link-type=html)(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

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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 (http://api.fdsys.gov/link?collection=plaw&congress=114&lawtype=public&lawnum=255&link-type=html)). 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 (/select-citation/2017/03/14/21-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:

Table 1—Class II Devices 21 CFR section

Product code

Device type

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

Partial exemption limitation (if applicable)

862.1020 Acid Phosphatase, CKH Beta Glycerophosphate 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, MultiAnalyte 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, KLI Non-Radiolabeled, Total Thyroxine 862.2265 High Throughput DNA Sequence Analyzer

PFF

862.2570 Instrumentation For NSU Clinical Multiplex Test Systems 862.2570 Real Time Nucleic Acid Amplification System

OOI

862.2570 Mass Spectrometer For OTA Clinical Multiplex Test Systems 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, DKZ Amphetamine

Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., 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 (e.g., 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 (e.g., 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 (e.g., 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 (e.g., 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, DJL Barbiturate

Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., 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, DIS Barbiturate

Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., 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 (e.g., 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 (e.g., 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 (e.g., 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 (e.g., 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 (e.g., 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 (e.g., 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, JXM Benzodiazepine

Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., 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 (e.g., 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 (e.g., 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 (e.g., 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 (e.g., 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, DIO Cocaine and Cocaine Metabolites

Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., 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 (e.g., 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, JXO Cocaine

Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., 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 (e.g., 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 (e.g., 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 (e.g., 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 (e.g., 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 (e.g., 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 (e.g., 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 (e.g., 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 (e.g., 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 (e.g., 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 (e.g., 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 (e.g., 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 (e.g., 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 (e.g., 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 (e.g., 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 (e.g., 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, DJR Methadone

Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., 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 (e.g., 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 (e.g., 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 (e.g., 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 (e.g., 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 (e.g., 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 (e.g., 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 (e.g., 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 (e.g., 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 (e.g., 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 (e.g., 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 (e.g., 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 (e.g., 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 (e.g., 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 (e.g., 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, DNA Morphine-Barbiturate (125-I), Goat Antibody

Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., 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, DJG Opiates

Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., 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 (e.g., 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 (e.g., 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 (e.g., 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 (e.g., 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 (e.g., 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, JXN Propoxyphene

Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., 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 (e.g., 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 (e.g., 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 (e.g., 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, LDJ Cannabinoids

Exemption is limited to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., 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 (e.g., 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 (e.g., 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 (e.g., 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 (e.g., 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 (e.g., 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 ProthrombinProconvertin 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 KSA and White-Cell Counting 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 RedCell 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-PhenylEnediamine/EDTA (Spectrophotometric), Ceruloplasmin

JFQ

866.5210 Indirect Copper Assay, JFR Ceruloplasmin 866.5470 Hemoglobin, Chain Specific, Antigen, Antiserum, Control

DAM

866.5620 Alpha-2Macroglobulin, Rhodamine, Antigen, Antiserum, Control

DDT

866.5620 Alpha-2Macroglobulin, FITC, Antigen, Antiserum, Control

DDY

866.5620 Alpha-2Macroglobulin, Antigen, Antiserum, Control

DEB

866.5630 System, Test, Beta-2Microglobulin Immunological

JZG

866.5750 System, Test, Radioallergosorbent (RAST) Immunological

DHB

866.5910 Quality Control Material, Genetics, DNA

NZB

868.1040 Algesimeter, Powered

BSI

Exemption is limited to devices classified under 21 CFR 866.5750 (/select-citation/2017/03/14/21-CFR-866.5750) that are intended to detect any of the allergens included in table 2 of this document.

868.1400 Legging, Compression, LLK Non-Inflatable 868.2385 Analyzer, Nitrogen Dioxide

MRQ

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

870.1390 Trocar

DRC

870.1650 Syringe, Balloon Inflation

MAV

870.1875 Lung Sound Monitor

OCR

870.2675 Oscillometer

DRZ

870.2770 Analyzer, Body Composition

MNW

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

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

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.

Exemption is limited to accessory torque devices that are manually operated, non-patient contacting, and intended to manipulate noncerebral vascular guide wires.

Exemption is limited to non-patient contacting balloon inflation syringes intended only to inflate/deflate balloon catheters and monitor pressure within the balloon.

Exemption is limited to body composition analyzers which are not intended to diagnose or treat any medical condition.

Exemption is limited to cardiopulmonary bypass blood reservoirs that do not contain defoamers or blood filters.

872.3560 Reliner, Denture, Over EBP The Counter 872.3590 Denture, Plastic, Tooth ELM 872.3600 Denture Preformed (Partially Prefabricated Denture)

EKO

872.3890 Splint, Endodontic Stabilizing

ELS

872.5550 Ring, Teething, FluidFilled

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 ETS Noise (for Audiometric Testing) 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

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

876.1500 LED Light Source

NTN

876.1500 Endoscopic Guide Wire, GastroenterologyUrology

OCY

876.1500 Endoscopic Grasping/Cutting Instrument, NonPowered

OCZ

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

876.5025 Vibrator for Climax Control of Premature Ejaculation

PIA

876.5365 Dilator, Esophageal (Metal Olive) GastroUrology

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 SelfRetaining 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, OperatingRoom

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

Exemption is limited to endoscopic magnetic retrievers intended for single use.

Exemption is limited to sterile scissors for cystoscope intended for single use.

Exemption is limited to disposable, non-powered endoscopic grasping/cutting instruments intended for single use.

Exemption is limited to surgical biliary catheters that do not include a balloon component.

878.4580 Light, Surgical, Ceiling FSY Mounted 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

882.1540 Device, Galvanic Skin Response Measurement

GZO

882.1560 Device, Skin Potential Measurement

HCJ

882.1855 Encephalogram Telemetry System

GYE

882.5895 Vibratory CounterStimulation

OVP

884.1630 Colposcope (and Colpomicroscope)

HEX

884.2990 Sheet, Recording, Breast Examination

NHM

884.3200 Drain, Cervical

HFL

884.4400 Forceps, Obstetrical

HDA

884.4530 Tenaculum, Uterine

HDC

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

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.

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 smartphonebased.

Exemption is limited to sterile urterine tenaculum devices that do not use suction and are intended for single use.

884.4900 Table, Obstetrical, AC- HDD Powered (and Accessories) 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 HGZ Contact 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 MQJ Microinjectors, Assisted Reproduction 884.6160 Labware, Assisted Reproduction

MQK

886.1120 Photorefractor

MMF

886.1120 Camera, Ophthalmic, General-Use

PJZ

886.1250 Euthyscope, ACPowered

HMK

886.1570 Ophthalmoscope, ACPowered

HLI

886.1570 Ophthalmoscope, Battery-Powered

HLJ

886.1570 Ophthalmoscopes, Replacement Batteries, Hand-Held

MSG

886.1780 Retinoscope, ACPowered

HKL

886.1850 Biomicroscope, SlitLamp, AC-Powered

HJO

886.1945 Transilluminator, ACPowered

HJM

886.3320 Ocular Peg

MQU

886.4150 Tubing, Replacement, Phacofragmentation Unit

MSR

Exemption is limited to dishes and plates that are intended for general assisted reproduction technology procedures.

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.

Exemption is limited to ocular pegs supplied sterile.

886.4250 Unit, Electrolysis, AC- HRO Powered, Ophthalmic 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, ACPowered

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, HBK Pneumocephalographic 892.1850 Cassette, Radiographic IXA Film 892.1860 Changer, Radiographic KPX Film/Cassette 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.

Table 2—Class II Devices (§866.5750—Radioallergosorbent (RAST) Immunological Test Systems) Allergen code

Allergen product

Source (taxonomical name) Grass Pollens

g1

Sweet vernal grass

Anthoxanthum odoratum.

g3

Cocksfoot grass, Orchard grass

Dactylis glomerata.

g4

Meadow fescue

Festuca elatior.

g5

Rye-grass (perennial rye grass)

Lolium perenne.

g7

Common reed (common reed grass)

Phragmites communis.

g8

Meadow grass, Kentucky blue (June grass)

Poa pratensis.

g9

Redtop, Bentgrass

Agrostis stolonifera, Agrostis gigantea (Agrostis alba).

g11

Brome grass

Bromus inermis.

g12

Cultivated rye (cultivated rye grass)

Secale cereale.

g13

Velvet grass

Holcus lanatus.

g14

Cultivated oat (cultivated oat grass)

Avena sativa.

g15

Cultivated wheat (cultivated wheat grass)

Triticum aestivum (Triticum spp.).

g16

Meadow foxtail (meadow foxtail grass)

Alopecurus pratensis.

g17

Bahia grass

Paspalum notatum.

g24

Wheat grass, Western

Agropyron smithii (Elymus smithii).

g30

Bluegrass, annual

Poa annua.

g70

Wild rye grass

Elymus triticoides, Elymus condensatus.

g71

Canary grass

Phalaris arundinacea.

g201

Barley, cultivated

Hordeum vulgare.

g202

Maize, corn (cultivated corn)

Zea mays.

g203

Salt grass

Distichlis spicata.

g204

False oat-grass

Arrhenatherum elatius.

g216

Cyn d 1

Cynodon dactylon.

g701

Phl p 1.0102, Phl p 5.0101

Phleum pratense.

g702

Phl p 7.0101

Phleum pratense.

g703

Phl p 12.0101

Phleum pratense. Weed Pollens

w2

Western ragweed

Ambrosia psilostachya.

w4

False ragweed

Ambrosia acanthicarpa (Franseria acanthicarpa).

w5

Wormwood

Artemisia absinthium, Artemisia annua.

w6

Mugwort

Artemisia vulgaris.

w7

Marguerite, ox-eye daisy

Chrysanthemum leucanthemum.

w8

Dandelion

Taraxacum vulgare, Taraxacum officinale.

w9

Plantain (English), Ribwort

Plantago lanceolata.

w10

Goosefoot, lamb's quarters

Chenopodium album.

w11

Saltwort (prickly), Russian thistle

Salsola kali (Salsola pestifer).

w12

Goldenrod

Solidago virgaurea (Solidago spp.).

w13

Cocklebur, common

Xanthium commune.

w14

Common pigweed (rough pigweed)

Amaranthus retroflexus.

w15

Scale, Lenscale

Atriplex lentiformis.

w16

Rough marsh elder

Iva ciliate, Iva annua.

w17

Firebush (Kochia)

Kochia scoparia.

w18

Sheep sorrel

Rumex acetosella.

w19

Wall pellitory

Parietaria officinalis.

w20

Nettle (Common stinging nettle)

Urtica dioica.

w21

Wall pellitory

Parietaria judaica.

w22

Japanese hop (careless weed)

Humulus japonicas (Humulus scandens).

w23

Yellow dock, Yellow dockweed

Rumex crispus.

w24

Spiny pigweed

Amaranthus spinosus.

w27

Carnation

Dianthus spp.

w28

Rose

Rosa rugosa.

w33

Clover

Trifolium pratense.

w35

Mexican tea

Chenopodium ambrosioides.

w36

Rabbit bush

Ambrosia deltoidea (Franseria deltoides).

w37

Salt bush, annual

Atriplex wrightii.

w39

Water hemp, Western

Amaranthus rudis (Acnida tamariscina).

w41

Burrobrush

Hymenoclea salsola.

w42

Poverty weed

w43

Common sagebrush

Artemisia tridentata.

w45

Alfalfa

Medicago sativa.

w46

Dog fennel

Eupatorium capillifolium.

w53

Geranium

Geranium spp.

w67

Groundsel bush

Baccharis halimifolia.

w69

Iodine bush

Allenrolfea occidentalis.

w70

Ragweed, slender

Ambrosia confertiflora.

w75

Wing scale (wingscale)

Atriplex canescens.

w82

Careless weed

Amaranthus palmeri, Amaranthus hybridus.

w90

Japanese hop

Humulus japonicas (Humulus scandens).

w203

Rape (rape pollen)

Brassica napus.

w204

Sunflower

Helianthus annuus.

w206

Camomile

Matricaria chamomilla.

w207

Lupin

Lupinus spp.

w210

Sugar-beet

Beta vulgaris.

w211

Par j 2.0101

Parietaria judaica.

w231

Art v 1

Artemisia vulgaris (Mugwort).

w232

Sal k 1

Salsola kali.

w233

Art v 3

Artemisa vulgaris (LTP, Mugwort).

w234

Pla l 1

Plantago lanceolata.

w235

Che a 1.0101

Chenopodium album.

w236

Mer a 1.0101

Mercurialis annua.

a753

Art v 1

Artemisia vulgaris (Mugwort weed). Tree Pollens

t1

Box-elder (Maple)

Acer negundo, Acer saccharum.

t2

Gray alder, speckled alder (alder)

Alnus incana.

t4

Hazel, hazelnut

Corylus avellana, Corylus americana.

t5

American beech (beech)

Fagus grandifolia (Fagus americana).

t6

Mountain juniper, Mountain cedar

Juniperus ashei (Juniperus sabinoides).

t8

Elm

Ulmus americana.

t9

Olive

Olea europaea.

t10

Walnut

Juglans californica, Juglans nigra.

t11

Maple leaf sycamore, London plane, Plane tree

Platanus acerifolia.

t61

Sycamore

Platanus occidentalis.

t12

Willow

Salix caprea, Salix nigra.

t14

Cottonwood (Eastern Cottonwood/Black Cottonwood)

Populus deltoides.

t15

White ash

Fraxinus americana.

t16

White pine

Pinus strobus.

t18

Eucalyptus, gum-tree

Eucalyptus globulus (Eucalyptus spp.).

t19/t26

Acacia

Acacia longifolia (Acacia spp.).

t20

Mesquite

Prosopis glandulosa/ Prosopis juliflora.

t21

Melaleuca, cajeput tree

Melaleuca quinquenervia (Melaleuca leucadendron).

t22

Pecan, hickory

Carya illinoinensis (Carya pecan).

t23

Italian/Mediterranean/funeral cypress

Cupressus sempervirens.

t24

Japanese cypress

Chamaecyparis obtusa (Chamaecyparis spp.).

t25

Ash

Fraxinus excelsior.

t27

Maple, red

Acer rubrum.

t29

Acacia

Acacia spp.

t30

Birch, white

Betula populifolia.

t32

Willow, black

Salix nigra.

t33

Ash, Arizona

Fraxinus velutina.

t35

Cedar, salt

Tamarix gallica.

t37

Bald cypress (white bald cypress)

Taxodium distichum.

t38

Elm, Chinese/Siberian

Ulmus pumila.

t40

Hazelnut tree

Corylus americana.

t41

White hickory

Carya alba (Carya tomentosa).

t42

Oak, red

Quercus rubra.

t43

Loblolly pine

Pinus taeda.

t44

Hackberry

Celtis occidentalis.

t45

Cedar elm

Ulmus crassifolia.

t47

Juniper, one seed

Juniperus monosperma.

t48

Pine, lodgepole

Pinus contorta.

t49

Pine, ponderosa

Pinus ponderosa.

t50

Beech, European

Fagus sylvatica.

t51

Tree of Heaven

Ailanthus altissima.

t52

Western white pine

Pinus monticola.

t54

Russian olive

Elaeagnus angustifolia.

t55

Scotch broom

Cytisus scoparius.

t56

Bayberry

Myrica cerifera.

t57

Red cedar

Juniperus virginiana.

t60

Western juniper

Juniperus occidentalis.

t61

Sycamore

Platanus occidentalis.

t70

Mulberry (white mulberry)

Morus alba.

t71

Red mulberry

Morus rubra.

t72

Queen palm

Arecastrum romanzoffiamon.

t73

Australian pine

Casuarina equisetifolia.

t77

Oak mix (red, white, black)

Quercus spp.

t80

Japanese cypress

Chamaecyparis obtusa.

t81

Japanese alder

Alnus japonica.

t83

Mango tree

Mangifera indica.

t90

Walnut, black

Juglans nigra.

t96

Poplar, white (poplar)

Populus alba.

t103/t218 Virginia live oak (live oak)

Quercus virginiana.

t105

Pepper tree

Schinus molle.

t110

Orange tree

Citrus sinensis.

t201

Spruce, Norway spruce

Picea abies (Picea excelsa).

t202

Alder, smooth

Alnus incana spp. Rugosa (Alnus rugosa).

t203

Horse chestnut

Aesculus hippocastanum.

t205

Elder

Sambucus nigra.

t206

Chestnut

Castanea sativa.

t207

Douglas fir

Pseudotsuga menziesii (Pseudotsuga taxifolia).

t208

Linden

Tilia cordata.

t209

Horn beam

Carpinus betulus.

t210

Privet

Ligustrum vulgare.

t211

Sweet gum

Liquidambar styraciflua.

t212

Cedar

Libocedrus decurrens.

t213

Pine

Pinus radiata.

t214

Date palm

Phoenix canariensis.

t215

Lilac

Syringa vulgaris.

t217

Pepper tree

Schinus molle.

t217

Red alder

Alnus rubra.

t218

Virginia live oak

Quercus virginiana.

t218

Bayberry (bayberry/sweet gale)

Myrica gale.

t219

Palo verde

Cercidium floridum.

t219

Red cedar

Juniperus virginiana.

t220

Bet v 4

Betula verrucosa (Birch).

t221

Bet v 2.0101, Bet v 4

Betula verrucosa (Birch).

t222

Cypress (Arizona cypress)

Cupressus arizonica.

t223

Oil palm

Elaeis guineensis.

t224

Ole e 1

Olea europaea.

t225

Bet v 6

Betula verrucosa (Birch).

t226

Cup a 1

Cupressus arizonica.

t227

Ole e 7

Olea Europaea.

t228

Aspen, quaking

Populus tremuloides.

t229

Eastern hemlock

Tsuga canadensis.

t230

Redwood (sequoia)

Sequoia sempervirens.

t232

Pussy willow

Salix discolor.

t240

Ole e 9.0101

Olea Europaea.

t241

Pla a 1.0101

Platanus acerifolia.

t242

Pla a 2

Platanus acerifolia.

t243

Pla a 3.0101

Platanus acerifolia.

t244

Cor a 1.0103

Corylus avellana.

t245

Aln g 1.0101

Alnus glutinosa.

t246

Cry j 1

Cryptomeria japonica.

t280

Locust tree

Robinia pseudoacacia.

t401

Brazilian peppertree

Schinus terebinthifolius.

t402

Mastic tree

Pistacia lentiscus.

t404

Tree of heaven

Ailanthus altissima.

t406

Date palm

Phoenix dactylifera.

a482

Ole e 1

Olea europaea (Olive Oil). Mites

d207

Blo t 5.0101

Blomia tropicalis.

d208

Lep d 2.0101

Lepidoglyphus destructor. Microorganisms, Molds, Yeast

m1

Penicillium chrysogenum (Penicillium notatum)

Penicillium chrysogenum (Penicillium notatum).

m2

Cladosporium herbarum (Hormodendrum)

Cladosporium herbarum (Hormodendrum).

m3

Aspergillus fumigatus

Aspergillus fumigatus.

m4

Mucor racemosus

Mucor racemosus.

m5

Candida albicans

Candida albicans.

m7

Botrytis cinerea

Botrytis cinerea.

m8

Drechslera halodes (Setomelanomma rostrata, Helminthosporium halodes, Helminthosporium interseminatum)

Drechslera halodes (Setomelanomma rostrata, Helminthosporium halodes).

m9

Fusarium moniliforme (Fusarium proliferatum)

Fusarium moniliforme (Fusarium proliferatum).

m10

Stemphylium botryosum

Stemphylium herbarum (Stemphylium botryosum).

m11

Rhizopus nigricans

Rhizopus nigricans.

m12

Aureobasidium pullulans

Aureobasidium pullulans.

m13

Phoma betae

Phoma betae.

m14

Epicoccum purpurascens

Epicoccum purpurascens (Epicoccum nigrum).

m15

Trichoderma viride

Trichoderma viride.

m16

Curvularia lunata

Curvularia lunata Curvularia specifera (K923044).

m17

Cladosporium fulvum

Cladosporium fulvum.

m18

Fusarium culmorum

Fusarium culmorum.

m19

Aspergillus versicolor

Aspergillus versicolor.

m20

Mucor mucedo

Mucor mucedo.

m21

Aspergillus clavatus

Aspergillus clavatus.

m22

Micropolyspora faeni

Saccharopolyspora rectivirgula (Micropolyspora faeni).

m23

Thermoactinomyces vulgaris

Thermoactinomyces vulgaris.

m24

Stachybotrys atra

Stachybotrys chartarum (Stachybotrys atra).

m24

Paecilomyces spp

Paecilomyces spp.

m25

Aspergillus versicolor

Aspergillus versicolor.

m25

Penicillium brevicompactum

Penicillium brevicompactum.

m26

Cladosporium cladosporioides

Cladosporium cladosporioides.

m26

Penicillium citrinum

Penicillium citrinum.

m27

Penicillium spp

Penicillium spp.

m29

Aspergillus repens

Aspergillus repens.

m30

Penicillium roqueforti

Penicillium roqueforti.

m32

Cladosporium cladosporioides

Cladosporium cladosporioides.

m34

Serpula lacrymans

Serpula lacrymans.

m36

Aspergillus terreus

Aspergillus terreus.

m37

Trichophyton mentagrophytes

Trichophyton mentagrophytes.

m40

Aspergillus amstelodami

Aspergillus amstelodami.

m43

Saccharomyces carlsberg

Saccharomyces carlsbergensis.

m44

Saccharomyces cerevisiae

Saccharomyces cerevisiae.

m45

Hormodendrum hordei

Hormodendrum hordei.

m46

Bipolaris spicifera

Bipolaris spicifera.

m47

Aspergillus nidulans

Aspergillus nidulans.

m48

Aspergillus oryzae

Aspergillus oryzae.

m49

Fusarium oxysporum

Fusarium oxysporum.

m50

Micropolyspora faeni

Saccharopolyspora rectivirgula (Micropolyspora faeni).

m51

Thermoactinomyces vulgaris

Thermoactinomyces vulgaris.

m53

Microspora canis

Microsporum canis (Microspora canis).

m54

Aspergillus flavus

Aspergillus flavus.

m63

Helminthosporium intersemin

Helminthosporium intersemin.

m66

Mucor plumbeus

Mucor plumbeus.

m67

Mycogone

Mycogone perniciosa.

m68

Nigrospora oryzae

Nigrospora oryzae.

m69

Rhodotorula

Rhodotorula rubra (Rhodotorula mucilaginosa).

m70

Malassezia furfur (Pityrosporum orbiculare)

Malassezia furfur (Pityrosporum orbiculare).

m71

Spondylocladium

Spondylocladium spp.

m72

Epidermophyton

Epidermophyton floccosum.

m73

Epicoccum nigrum

Epicoccum purpurascens (Epicoccum nigrum).

m80

Staphylococcal enterotoxin A (Sta a SEA)

Staphylococcus aureus.

m80

Helminthosporium spp

Helminthosporium spp.

m81

Staphylococcal enterotoxin B (Sta a SEB)

Staphylococcus aureus.

m88

Stemphylium solani

Stemphylium solani.

m93

Gliocladium fimbriatum

Gliocladium fimbriatum.

m94

Phycomyces blakesleeanus

Phycomyces blakesleeanus.

m201

Tilletia tritici (Ustilago nuda, Ustilago tritici) (Barley smut)

Tilletia tritici (Ustilago nuda, Ustilago tritici).

m202

Acremonium kiliense (Cephalosporium acremonium)

Acremonium kiliense (Cephalosporium acremonium).

m203

Trichosporon pullulans

Trichosporon pullulans.

m204

Ulocladium chartarum

Ulocladium chartarum.

m205

Trichophyton rubrum

Trichophyton rubrum.

m207

Aspergillus niger

Aspergillus niger.

m208

Chaetomium globosum

Chaetomium globosum.

m209

Penicillium frequentans

Penicillium glabrum (Penicillium frequentans).

m209

Stachybotrys chartarum

Stachybotrys chartarum (Stachybotrys atra).

m210

Trichophyton mentagrophytes var. goetzii

Trichophyton mentagrophytes var. goetzii.

m211

Trichophyton mentagrophytes var. interdigitale

Trichophyton mentagrophytes var. interdigitale.

m211

Oat smut

Ustilago avenae.

m212

Micropolyspora faeni

Saccharopolyspora rectivirgula (Micropolyspora faeni).

m212

Geotrichum candidum

Geotrichum candidum.

m213

Bermuda grass smut

Ustilago cynodontis.

m214

Johnson grass smut

Sphacelotheca cruenta.

m215

Corn smut

Ustilago maydis.

m218

Asp f 1.0101

Aspergillus fumigatus.

a3050

Asp r 1

Aspergillus restrictus.

m219

Asp f 2

Aspergillus fumigatus.

m220

Asp f 3.0101

Aspergillus fumigatus.

m221

Asp f 4

Aspergillus fumigatus.

m222

Asp f 6.0101

Aspergillus fumigatus.

m223

Staphylococal enterotoxin C (Sta a SEC)

Staphylococus aureus.

m224

Staphylococcal enterotoxin D (Sta a SED)

Staphylococcus aureus.

m226

Staphylococcal enterotoxin TSST (Sta a TSST)

Staphylococcus aureus.

m227

Malassezia spp. (Pityrosporum spp.)

Malassezia spp. (Pityrosporum spp.).

m228

Aspergillus flavus.

m229

Alt a 1.0101

Alternaria alternata (Alternaria tenuis).

m230

Alt a 6.0101

Alternaria alternata (Alternaria tenuis).

m231

Cla h 8.0101

Cladosporium herbarum (Hormodendrum).

m300

Eurotium spp.

Eurotium spp.

m304

Aspergillus oryzae

Aspergillus oryzae.

m305

Penicillium brevicompactum

Penicillium brevicompactum.

m309

Aspergillus terreus

Aspergillus terreus.

m310

Aspergillus nidulans

Aspergillus nidulans.

m311

Aspergillus flavus

Aspergillus flavus.

m312

Aspergillus clavatus

Aspergillus clavatus. Epidermal & Animal

e6

Guinea pig epithelium

Cavia porcellus.

e7

Pigeon droppings

Columba palumbus, Columba livia.

e25

Chicken serum

Gallus domesticus (Gallus gallus domesticus; Gallus spp.).

e26

Parrot serum

Psittacoidea spp.

e62

Camel

Camelus dromedaries.

e70

Goose feathers

Anser anser.

e71

Mouse epithelium

Mus musculus (Mus spp.).

e73

Rat epithelium

Rattus norvegicus.

e74

Rat urine proteins

Rattus norvegicus Rattus rattus.

e75

Rat serum proteins

Rattus norvegicus Rattus rattus.

e76

Mouse serum proteins

Mus musculus (Mus spp.).

e77

Budgerigar droppings

Melopsittacus undulatus.

e78

Budgerigar feathers

Melopsittacus undulatus.

e79

Budgerigar serum proteins

Melopsittacus undulatus.

e80

Goat epithelium

Capra hircus.

e81

Sheep epithelium

Ovis aries (Ovis spp.).

e82

Rabbit epithelium

Oryctolagus cuniculus (Oryctolagus spp.).

e83

Swine epithelium

Sus scrofa (Sus scrofa domesticus; Sus spp.).

e84

Hamster epithelium

Cricetus cricetus, Mesocricetus auratus, and Phodopus sungorus.

e85

Chicken feathers

Gallus domesticus (Gallus gallus domesticus; Gallus spp.).

e86

Duck feathers

Anas platyrhynchos.

e87

Rat epithelium, serum proteins, and urine proteins

Rattus norvegicus Rattus rattus.

e88

Mouse epithelium, serum proteins, and urine proteins (mouse)

Mus musculus (Mus spp.).

e89

Turkey feathers

Meleagris gallopavo.

e90

Budgerigar serum proteins, feathers, and droppings

Melopsittacus undulatus.

e91

Pigeon serum proteins, feathers, and droppings

Streptopelia roseogrisea Psittacidae spp.

e92

Parrot serum proteins, feathers, and droppings

Ara spp.

e93

Pigeon serum proteins

Streptopelia roseogrisea.

e94

Fel d 1.0101

Felis domesticus.

a345

Fel d 1

Felis domesticus.

e98

Parrot droppings

Psittacoidea spp.

e101

Can f 1.0101

Canis familiaris (Canis domesticus).

a174

Can f 1

Canis familiaris (Canis domesticus).

e102

Can f 2.0101

Canis familiaris (Canis domesticus).

e196

Parakeet feathers

Nymphicus hollandicus.

e197

Parakeet droppings

Nymphicus hollandicus.

e198

Parakeet serum

Nymphicus hollandicus.

e199

Canary bird serum

Serinus canarius.

e200

Canary bird droppings

Serinus canarius.

e201

Canary bird feathers (Canary feathers)

Serinus canarius.

e202

Reindeer epithelium

Rangifer tarandus.

e203

Mink epithelium

Mustela spp.

e204

Bos d 6

Bos domesticus (Bos taurus; Bos spp.).

e205

Horse, serum proteins

Equus caballus (Equus spp.).

e206

Rabbit, serum proteins

Oryctolagus cuniculus (Oryctolagus spp.).

e208

Chinchilla epithelium

Chinchilla laniger.

e209

Gerbil epithelium

Meriones unguiculatus.

e210

Fox epithelium

Vulpes vulpes.

e211

Rabbit, urine proteins

Oryctolagus cuniculus (Oryctolagus spp.).

e212

Swine, urine proteins

Sus scrofa (Sus scrofa domesticus; Sus spp.).

e213

Parrot feathers

Ara spp.

e214

Finch feathers

Lonchura domestica.

e215

Pigeon feathers

Streptopelia roseogrisea (Streptopelia spp.), Columbia spp.

e216

Deer epithelium

Dama dama.

e217

Ferret epithelium

Mustela putorius.

e218

Chicken droppings

Gallus domesticus (Gallus gallus domesticus; Gallus spp.).

e219

Chicken, serum proteins

Gallus domesticus (Gallus gallus domesticus; Gallus spp.).

e220

Fel d 2, Cat serum albumin

Felis domesticus.

e221

Can f 3

Canis familiaris (Canis domesticus) (Dog serum albumin).

e222

Swine serum albumin (Sus s PSA)

Sus scrofa (Sus scrofa domesticus; Sus spp.).

e225

Lovebird feathers

Psittacoidea agapomis.

e226

Can f 5.0101

Canis familiaris.

e227

Equ c 1.0101

Equus caballus.

e228

Fel d 4.0101

Felis domesticus.

e230

Equ c 3

Equus caballus.

e231

Mus m 1

Mus musculus. Food

f9

Rice

Oryza sativa.

f12

Pea (green pea)

Pisum sativum.

f15

White bean

Phaseolus vulgaris.

f19

Cayenne pepper

Capsicum frutescens, (Capsicum annum).

f21

Sugar cane

Saccharum officinarum.

f22

Raspberry

Rubus idaeus.

f26

Pork

Sus scrofa (Sus scrofa domesticus; Sus spp.).

f29

Watermelon

Citrullus lanatus (Citrullus vulgaris).

f31

Carrot

Daucus carota.

f32

Oyster mushroom

Pleurotus ostreatus.

f33

Orange

Citrus sinensis.

f35

Potato

Solanum tuberosum.

f43

Mother's milk

Homo sapiens.

f44

Strawberry

Fragaria vesca (Fragaria spp.).

f45

Yeast, baker's

Saccharomyces cerevisiae.

f46

Pepper, Red

Capsicum annuum.

f47

Garlic

Allium sativum.

f48

Onion

Allium cepa.

f49

Apple

Malus x domestica (Malus spp.).

f51

Bamboo shoot

Phyllostachys pubescens.

f52

Cacao/chocolate

Theobroma cacao.

f54

Sweet potato

Ipomoea batatas.

f55

Common millet

Panicum miliaceum.

f56

Foxtail millet

Setaria italica.

f57

Japanese millet

Echinochloa crus-galli.

f58

Pacific squid

Todarodes pacificus.

f59

Octopus

Octopus vulgaris (Octopus spp.).

f63

Kefir

NA.

f67

Parmesan cheese

NA.

f81

Cheese, cheddar type

NA.

f82

Cheese, mold type

NA.

f83

Chicken

Gallus domesticus (Gallus gallus domesticus; Gallus spp.).

f86

Parsley

Petroselinum crispum.

f87

Melon

Cucumis melo Cucumis melo + Citrullus lanatus.

f88

Mutton (lamb)

Ovis aries (Ovis spp.).

f90

Malt

Hordeum vulgare.

f92

Banana

Musa spp.

f93

Cacao

Theobroma cacao.

f94

Pear

Pyrus communis (Pyrus spp.).

f97

Yam

Dioscorea spp., Dioscorea opposita.

f97

Chamomile tea

Matricaria chamomilla.

f98

Gliadin

Triticum aestivum (Triticum spp.).

f102

Cantaloupe

Cucumis melo var. cantalupensis.

f105

Chocolate

Theobroma cacao.

f109

Cottonseed

Gossypium hirsutum.

f110

Giant radish

Raphanus sativus.

f118

Zucchini

Cucurbita pepo.

f119

Radish

Raphanus sativus.

f120

Venison

Capreolus capeolus.

f121

Pinto bean

Phaseolus vulgaris.

f122

Cheese, American

NA.

f127

Black-eyed pea

Vigna unguiculata.

f131

Black Olive

Olea europaea.

f136

Red beet

Beta vulgaris var. conditiva.

f139

Goat's Cheese

Capra aegagrus.

f140

Bran

NA.

f141

Corn (vegetables)

Zea mays.

f152

Green bell pepper

Capsicum annuum.

f155

Brewer's yeast

Saccharomyces carlsbergensis.

f157

Duck

Anas domesticus.

f158

Goose

Anser anser.

f160

Camembert cheese

NA.

f162

Nectarine

Prunus persica var. nucipersica.

f163

Kohlrabi

Brassica oleracea var. gongylodes.

f65

Perch

f166

Leek

Allium porrum.

f170

Cheese (Switzerland) (Swiss cheese)

NA.

f174

Fig

Ficus carica.

f177

Cranberry

Vaccinium macrocarpon.

f179

Raisin

Vitis spp.

f182

Lima bean

Phaseolus lunatus.

f198

Flaxseed (bruised grain)

Linum usitatissimum.

f199

Untreated native milk

Bos domesticus (Bos taurus; Bos spp.).

f208

Lemon

Citrus limon.

f209

Grapefruit

Citrus paradisi.

f210

Pineapple

Ananas comosus.

f211

Blackberry

Rubus fruticosus.

f212

Mushroom (champignon)

Agaricus hortensis (Agaricus spp.).

f213

Rabbit

Oryctolagus cuniculus (Oryctolagus spp.).

f214

Spinach

Spinacia oleracea.

f215

Lettuce

Lactuca sativa.

f216

Cabbage

Brassica oleracea var. capitata.

f217

Brussels sprouts

Brassica oleracea var. gem.

f218

Paprika, sweet pepper

Capsicum annuum.

f219

Fennel seed

Foeniculum vulgare.

f219

Sage

Salvia officinalis.

f220

Cinnamon

Cinnamomum spp.

f221

Coffee

Coffea spp.

f222

Tea

Camellia sinensis.

f223

Green olive

Olea europaea.

f225

Summer squash, pumpkin

Cucurbita pepo.

f225

Pumpkin

Cucurbita maxima.

f226

Pumpkin seed

Cucurbita pepo.

f227

Sugar-beet seed

Beta vulgaris.

f229

Safflower Seed

Carthamus tinctorius.

f231

Milk, boiled

Bos domesticus (Bos taurus; Bos spp.).

f234

Vanilla

Vanilla planifolia.

f237

Apricot

Prunus armeniaca.

f241

Gouda cheese

NA.

f242

Cherry

Prunus avium.

f244

Cucumber

Cucumis sativus.

f246

Guar, guar gum

Cyamopsis tetragonoloba.

f247

Honey

NA.

f248

Rosemary

Rosmarinus officinalis.

f254

Plaice

Pleuronectes platessa.

f255

Plum

Prunus domestica, Prunus americana.

f258

Squid

Loligo spp.

f259

Grape

Vitis vinifera (Vitis spp.).

f260

Broccoli

Brassica oleracea var. italica (Brassica oleracea var. cultivar).

f261

Asparagus

Asparagus officinalis.

f262

Aubergine, eggplant

Solanum melongena.

f263

Green pepper

Piper nigrum, Capsicum annuum.

f264

Eel

Anguilla anguilla.

f265

Caraway

Carum carvi.

f265

Cumin

Cuminum cyminum.

f266

Mace

Myristica fragrans.

f267

Cardamon

Elettaria cardamomum.

f268

Clove

Syzygium aromaticum.

f269

Basil

Ocimum basilicum.

f270

Ginger

Zingiber officinale.

f271

Anise

Pimpinella anisum.

f272

Tarragon

Artemisia dracunculus.

f273

Thyme

Thymus vulgaris.

f274

Marjoram

Origanum majorana.

f275

Lovage

Levisticum officinale.

f276

Fennel, fresh

Foeniculum vulgare.

f277

Dill

Anethum graveolens.

f278

Bay leaf

Laurus nobilis.

f279

Chili pepper

Capsicum frutescens.

f280

Black pepper

Piper nigrum.

f281

Curry (Santa Maria)

NA.

f282

Nutmeg

Myristica fragrans.

f283

Oregano

Origanum vulgare.

f284

Turkey meat

Meleagris gallopavo.

f285

Elk/moose meat

Alces spp.

f286

Mare's milk

Equus caballus (Equus spp.).

f287

Red kidney bean

Phaseolus vulgaris.

f288

Blueberry

Vaccinium myrtillus (Vaccinium spp.).

f289

Date

Phoenix dactylifera.

f291

Cauliflower

Brassica oleracea var. botrytis.

f292

Guava

Psidium guajava.

f293

Papaya

Carica papaya.

f294

Passion fruit, Maracuja

Passiflora edulis (Passiflora spp.).

f295

Carambola

Averrhoa carambola.

f296

Carob

Ceratonia siliqua.

f297

Gum arabic

Acacia senegal (Acacia spp.).

f298

Tragacanth

Astragalus spp.

f299

Sweet chestnut (chestnut)

Castanea sativa.

f300

Pinto bean

Phaseolus spp.

f301

Persimmon (kaki fruit, sharon)

Diospyros kaki.

f302

Mandarin (tangerine, clementine, satsumas)

Citrus reticulata.

f305

Fenugreek

Trigonella foenum-graecum.

f306

Lime

Citrus aurantifolia.

f307

Hake

Merluccius merluccius.

f308

Sardine (pilchard)

Sardina pilchardus.

f310

Blue vetch

Lathyrus sativus.

f311

Megrim

Lepidorhombus whiffiagonis.

f315

Green bean

Phaseolus vulgaris.

f316

Rape seed

Brassica napus.

f317

Coriander

Coriandrum sativum.

f318

Jack fruit

Artocarpus heterophyllus.

f319

Beetroot

Beta vulgaris.

f320

Crayfish

Astacus astacus.

f321

Horse meat

Equus caballus (Equus spp.).

f322

Red currant

Ribes sylvestre.

f324

Hop (fruit cone)

Humulus lupulus.

f325

Saffron

Colchicum autumnale.

f328

Fig

Ficus carica.

f329

Watermelon

Citrullus lanatus.

f330

Rose hip

Rosa spp.

f331

Saffron

Crocus sativus.

f332

Mint

Mentha piperita.

f333

Linseed

Linum usitatissimum.

f336

Jujube

Ziziphus jujuba.

f336

Wine vinegar

Vitis vinifera (Vitis spp.).

f337

Sole

Solea solea.

f337

English sole

Parophrys vetulus.

f338

Wine, white

Vitis vinifera (Vitis spp.).

f339

Allspice

Pimenta dioica.

f339

Wine, red

Vitis vinifera (Vitis spp.).

f341

Cranberry

Vaccinium oxycoccus, Vaccinium macrocarpon.

f342

Olive (black, fresh)

Olea europaea.

f343

Raspberry

Rubus idaeus.

f344

Sage

Salvia officinalis.

f346

Chives

Allium schoenoprasum.

f347

Quinoa

Chenopodium quinoa.

f348

Litchi

Litchi chinensis.

f349

Chum salmon roe

Oncorhynchus keta.

f358

Artichoke

Cynara scolymus.

f360

Yogurt

NA.

f368

Black bass

Micropterus dolomieu (Micropterus dolomieui).

f374

Karaya gum

Sterculia urens.

f375

Horseradish

Armoracia rusticana.

f377

Maple syrup

NA.

f379

Okra

Abelmoschus esculentus.

f382

Beet, sugar

Beta vulgaris var. altissima.

f401

Loquat

Eriobotrya japonica.

f402

Fig

Ficus carica.

f403

Brewer's yeast

Saccharomyces cerevisiae.

f405

Mint

Mentha spp.

f406

Arugula

Eruca vesicaria. House Dust

h1

Greer Labs., Inc

NA.

h2

Hollister-Stier Labs

NA.

h6

Japan

NA. Venoms & Insects

i7

Midge

Chironomus yoshimatsui.

i8

Moth

Bombyx mori, Heterocera spp.

i47

Water flea

Daphnia spp.

i49

Deer fly

Chrysops spp.

i51

Black ant

Camponotus pennsylvanicus.

i54

Flea mix (dog/cat), common flea

Ctenocephalides spp.

i71

Mosquito

Aedes communis, Aedes spp. and Culex spp.

i72

Green nimitti

Cladotanytarsus lewisi.

i73

Blood worm

Chironomus thummi, Chironomusri parius, Chironomus spp.

i75

European hornet

Vespa crabro.

i76

Berlin beetle

Trogoderma angustum.

i77

European paper wasp

Polistes dominulus.

i78

Fly

Musca domestica.

i80

Bumblebee

Bombus pennsylvanicus.

i201

Horse bot fly

Gasterophilus intestinalis.

i202

Grain weevil

Sitophilus granarius.

i203

Mediterranean flour moth

Ephestia kuehniella (Anagasta kuehniella).

i204

Horse fly

Tabanus spp.

i205

Bumblebee

Bombus terrestris.

i208

Api m 1.0101

Apis mellifera.

a45

Api m 1

Apis mellifera.

i209

Ves v 5.0101

Vespula vulgaris.

a670

Ves v 5

Vespula vulgaris.

i210

Pol d 5.0101

Polistes dominulus.

i211

Ves v 1.0101

Vespula vulgaris.

i213

Api m 4

Apis mellifera.

i214

Api m 2

Apis mellifera.

i215

Api m 3

Apis mellifera.

i216

Api m 5

Apis mellifera.

i217

Api m 10

Apis mellifera.

i220

Bla g 1.0101

Blattella germanica.

i221

Bla g 2.0101

Blattella germanica.

i222

Bla g 5.0101

Blattella germanica.

i223

Bla g 7

Blattella germanica.

a46

Api m 2

Apis mellifera. Miscellaneous

o1

Cotton, crude fibers

Gossypium spp.

o3

Cotton (treated)

Gossypium spp.

o70

Seminal fluid

Homo sapiens.

o71

Staphylococcus aureus

Staphylococcus aureus.

o72

Pichia pastoris crude extract customer specific

Pichia pastoris.

o72

Sperm-sediment

Homo sapiens.

o73

Pichia pastoris crude extr. vector customer specific

Pichia pastoris.

o74

Pichia pastoris with vector customer specific

Pichia pastoris.

o201

Tobacco leaf, tobacco dust

Nicotiana tabacum.

o202

Artemia salina, fish feed

Artemia salina.

o203

Tetramin, fish feed

NA.

o207

Daphnia, fish feed

Daphnia spp.

o211

Mealworm

Tenebrio molitor.

o212

Streptavidin

Streptomyces avidini.

o213

MBP (maltose binding protein)

Escherichia coli.

o214

CCD; MUXF3 from bromelain

Ananas comosus.

o72

Enterotoxin A (Sta a SEA)

Staphylococcus aureus.

o73

Enterotoxin B (Sta a SEB)

Staphylococcus aureus. Parasites

p1

Ascaris

Ascaris suum.

p2

Echinococcus

Echinococcus granulosus.

p3

Schistosoma

Schistosoma mansoni.

p4

Anisakis (Herring Worm)

Anisakis simplex (Anisakis spp.).

p5

Toxocara canis

Toxocara canis.

p10

Ani s 3.0101

Anisakis simplex (Anisakis spp.).

p11

Ani s 1

Anisakis simplex (Anisakis spp.). Occupational

k4

Threshing dust

NA.

k5

Flax

NA.

k7

Hay Dust

NA.

k8

Hop (hops)

Humulus lupulus.

k12

Grain mill dust

NA.

k14

Kapok

NA.

k20

Sheep's wool (treated) (wool)

Ovis aries (Ovis spp.).

k21

Sheep's wool (Untreated)

Ovis aries (Ovis spp.).

k23

Straw Dust

NA.

k33

Oak

NA.

k70

Green coffee bean

Coffea spp.

k71

Castor bean

Ricinus communis.

k72

Ispaghula

Plantago psyllium/Plantago ovata.

k73

Silk waste

NA.

k74

Silk

Bombyx mori.

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

Ficus benjamina (Ficus spp.).

k83

Cotton seed

Gossypium hirsutum.

k84

Sunflower seed

Helianthus annuus.

k85

Chloramin T

NA.

k86

Trimellitic anhydride, TMA

NA.

k87

Asp o 21, alpha-amylase

Aspergillus oryzae.

k89

Orris root

Iris florentina.

k99

HSA (Human Serum Albumin) (Hom s HSA)

Homo sapiens.

k201

Car p 1, Papain

Carica papaya.

k202

Ana c 2, Bromelain

Ananas comosus.

k204

Maxatase

Bacillus licheniformis.

k205

Alcalase

Bacillus spp.

k206

Savinase, Protease 1 (Bac l Subtilisin)

Bacillus spp.

k208

Gal d 4, Lysozyme

Gallus domesticus (Gallus gallus domesticus; Gallus spp.).

k209

Hexahydrophtalic anhydrid

NA.

k210

Maleic anhydride

NA.

k211

Methyltetrahydrophtalic anhydrid

NA.

k212

Abachi wood dust

Triplochiton scleroxylon.

k213

Pepsin (Sus s Pepsin)

Sus scrofa (Sus scrofa domesticus; Sus spp.).

k213

TCPA

NA.

k214

Bougainvillea

Bougainvillea spp.

k225

Horse radish peroxidase (Arm r HRP)

Armoracia rusticana.

k226

Ascorbate oxidase (Cuc p ascorbate oxidase)

Cucurbita pepo.

k301

Flour dust

Triticum 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 http://www.regulations.gov (http://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 (http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf). Dated: March 8, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-04938 (/a/2017-04938) Filed 3-13-17; 8:45 am] BILLING CODE 4164-01-P PUBLISHED DOCUMENT

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Federal Register :: Medical Devices; Exemptions From Premarket

LEGAL STATUS LEGAL STATUS Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments A Notice by the Food and Dr...

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