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Federal Register / Vol. 86, No. 222 / Monday, November 22, 2021 / Rules and Regulations
plasma, or other matrices as a prescription device that aids in the diagnosis of HCV infection in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis C
infection. The test is not intended for screening blood, plasma, cell, or tissue donors.
Under this final order, HCV antibody tests are identified as prescription use only devices and as such, HCV antibody tests must satisfy prescription labeling requirements for in vitro diagnostic products see 21 CFR 809.10a4 and b5ii. Under 21 CFR 807.81, the device continues to be subject to 510k requirements.
IV. Codification of Orders Prior to the amendments in the Food and Drug Administration Safety and Innovation Act Pub. L. 112144
FDASIA, section 513e of the FD&C
Act provided for FDA to issue regulations to reclassify devices.
Although section 513e, as amended by FDASIA, requires FDA to issue final orders rather than regulations, it also provides for FDA to revoke previously issued regulations by order. FDA will continue to codify classifications and reclassifications in the CFR. Changes resulting from final orders will appear in the CFR as changes to codified classification determinations or as newly codified orders. Therefore, under section 513e1Ai, as amended by FDASIA, in this final order, we are proposing to codify the classification of hepatitis c virus antibody tests in the new 866.3169, under which HCV
antibody tests would be reclassified into class II.

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V. Analysis of Environmental Impact The Agency has determined under 21
CFR 25.34b that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
VI. Paperwork Reduction Act of 1995
This final order establishes special controls that refer to previously approved FDA collections. These collections of information are subject to review by the Office of Management and Budget OMB under the Paperwork Reduction Act of 1995 44 U.S.C. 3501
3521. The collections of information in part 807, subpart E have been approved under OMB control number 09100120;
the collections of information in 21 CFR
parts 801 and 809 have been approved under OMB control number 09100485;
and the collections of information in 21

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CFR part 820 have been approved under OMB control number 09100073.

VII. References The following references are on display at the Dockets Management Staff HFA305, Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 240402
7500 and are available for viewing by interested persons between 9 a.m. and 4
p.m., Monday through Friday; they also are available electronically at https
www.regulations.gov. FDA has verified the website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time.

866.3169
tests.

1. De Novo Classification Process Evaluation of Automatic Class III
DesignationGuidance for Industry and Food and Drug Administration Staff, issued October 30, 2017 available at https www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/de-novo-classificationprocess-evaluation-automatic-class-iiidesignation.
2. Acceptance Review for De Novo Classification RequestsGuidance for Industry and Food and Drug Administration Staff, issued September 9, 2019 available at https
www.fda.gov/regulatory-information/
search-fda-guidance-documents/
acceptance-review-de-novoclassification-requests.
3. Requests for Feedback and Meetings for Medical Device Submissions: The QSubmission ProgramGuidance for Industry and Food and Drug Administration Staff, issued May 7, 2019 available at https www.fda.gov/
regulatory-information/search-fdaguidance-documents/requests-feedbackand-meetings-medical-devicesubmissions-q-submission-program.
4. Transcript of the FDA Microbiology Devices Panel Meeting, March 22, 2018
available at https www.fda.gov/
downloads/AdvisoryCommittees/
CommitteesMeetingMaterials/
BloodVaccinesandOtherBiologics/
BloodProductsAdvisoryCommittee/
UCM630139.pdf.

List of Subjects in 21 CFR Part 866
Biologics, Laboratories, Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 866 is amended as follows:
PART 866IMMUNOLOGY AND
MICROBIOLOGY DEVICES
1. The authority citation for part 866
continues to read as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

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2. Add 866.3169 to subpart D to read as follows:
Hepatitis C virus antibody
a Identification. A hepatitis C virus HCV antibody test is identified as an in vitro diagnostic device intended for use with human serum, plasma, or other matrices as a prescription device that aids in the diagnosis of HCV infection in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis C infection. The test is not intended for screening blood, plasma, cell, or tissue donors.
b Classification. Class II special controls. The special controls for this device are:
1 The labeling required under 809.10b of this chapter must include:
i A prominent statement that the test is not intended for the screening of blood, plasma, and cell or tissue donors.
ii Limitations, which must be updated to reflect current clinical practice and disease presentation and management. The limitations must include, but are not limited to, statements that indicate:
A When appropriate, the performance characteristics of the test have not been established in populations of immunocompromised or immunosuppressed patients or, other special populations where test performance may be affected.
B The detection of HCV antibodies indicates a present or past infection with hepatitis C virus, but does not differentiate between acute, chronic, or resolved infection.
C The specimen types for which the device has been cleared, and that use of the test with specimen types other than those specifically cleared for this device may result in inaccurate test results.
D Test results are to be interpreted by qualified licensed healthcare professionals in conjunction with the individuals clinical presentation, history, and other laboratory results.
E A non-reactive test result may occur early during acute infection, prior to development of a host antibody response to infection, or when analyte levels are below the limit of detection of the test.
iii A detailed explanation of the principles of operation and procedures for performing the test.
2 Design verification and validation must include the following:
i A detailed device description, including all parts that make up the device, ancillary reagents required but not provided, an explanation of the device methodology, and design of the antigens and capture antibodyies
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