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Federal Register / Vol. 86, No. 222 / Monday, November 22, 2021 / Rules and Regulations
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manufacturers to obtain information on the study designs used to support the marketing authorizations of other nucleic-acid based HCV RNA tests Refs.
3 and 4.
III. The Final Order Based on the information discussed in the preamble to the proposed order April 2, 2020, the comments received for the proposed order, the 2018 Panel delibrations Ref. 5, and FDAs experiences over the years in reviewing these devices, FDA concludes that special controls, in conjunction with general controls, will provide a reasonable assurance of the safety and effectiveness of nucleic-acid based HCV
RNA tests. FDA is adopting its findings under section 513f3 of the FD&C Act, as published in the preamble to the proposed order. FDA is issuing this final order to reclassify nucleic acid-based HCV RNA devices intended for the qualitative or quantitative detection or genotyping of HCV RNA from class III
to class II, and to establish special controls by revising 21 CFR part 866. In this final order, the Agency has identified the special controls under section 513a1B of the FD&C Act that, together with general controls, provide a reasonable assurance of the safety and effectiveness of these devices.
Section 510m of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510k of the FD&C Act, if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device.
FDA has determined that premarket notification is necessary to provide a reasonable assurance of the safety and effectiveness of nucleic-acid based HCV
RNA tests. Therefore, these devices are not exempt from premarket notification requirements. Persons who intend to market a new nucleic-acid based HCV
RNA device intended for the qualitative or quantitative detection or genotyping of HCV RNA must submit to FDA a premarket notification, obtain clearance, and demonstrate compliance with the special controls included in this final order, prior to marketing the device.
These devices are assigned the generic name nucleic-acid based hepatitis C
virus ribonucleic acid tests and are identified as in vitro diagnostic devices intended for prescription use as an aid in the diagnosis of HCV infection in specified populations, and/or as an aid in the management of HCV-infected patients including guiding the selection of genotype-specific treatment in individuals with chronic HCV infection.
These tests are intended for use with
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human serum or plasma. These tests are not intended for use as a donor screening test for the presence of HCV
antibodies in blood, blood products, or tissue donors.
Under this final order, nucleic acidbased HCV RNA tests are identified as prescription use only devices and as such, nucleic acid-based HCV RNA 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.
As part of the process for issuance of this final order and on its own initiative, FDA has identified previously approved nucleic-acid based HCV RNA tests for use as an aid in diagnosis of HCV
infection without prior evidence of HCV
antibodies. In this final order, FDA has revised the device identification of nucleic-acid based HCV RNA tests to be codified in 866.3170a to clarify that nucleic acid-based HCV RNA tests can include devices used as an aid for diagnosis of HCV infection in specified populations without prior evidence of HCV antibodies because FDA believes that it may be appropriate to use these devices as a one-step diagnostic assay and in the absence of evidence of HCV
antibodies.
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 Code of Federal Regulations 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 nucleic-acid based hepatitis C virus ribonucleic acid tests in the new 866.3170, under which nucleic-acid based HCV RNA
tests would be reclassified into class II.
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
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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 801and 809 have been approved under OMB control number 09100485;
and the collections of information in 21
CFR part 820 have been approved under OMB control number 09100073.
VII. References The following references marked with an asterisk are on display at the Dockets Management Staff HFA305, Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852, 2404027500, 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. References without asterisks are not on public display at https www.regulations.gov because they have copyright restrictions. Some may be available at the website address, if listed. References without asterisks are available for viewing only at the Dockets Management Staff. 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.
1. Clinical and Laboratory Standards Institute. Interference Testing in Clinical Chemistry; Approved GuidelineSecond Edition. CLSI document EP07A2.
Wayne, PA: Clinical and Laboratory Standards Institute; 2005.
2. 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.
3. FDAs Premarket Approval Database available on FDAs website at https
www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfPMA/pma.cfm.
4. FDAs 510k Premarket Notification Database available on FDAs website at https www.accessdata.fda.gov/scripts/
cdrh/cfdocs/cfPMN/pmn.cfm.
5. Transcript of the FDA Microbiology Devices Panel Meeting, March 22, 2018

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