Federal Register - November 22, 2021
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Source: Federal Register
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Federal Register / Vol. 86, No. 222 / Monday, November 22, 2021 / Rules and Regulations intended for OTC use would be a new type of device not previously classified based on the criteria at section 513a1
of the FD&C Act and, as a result, such postamendments devices would be automatically classified into class III by operation of section 513f1 of the FD&C Act. FDA believes that an HCV
antibody test intended for OTC use may be a good candidate for the De Novo classification process under section 513f2 of the FD&C Act Refs. 1 and 2. FDA recommends that device manufacturers interested in marketing an HCV antibody test for OTC use submit a Pre-Submission to request FDA
feedback on the studies and data that may be necessary to support a De Novo request Ref. 3.
Similarly, to date, FDA has only approved HCV antibody tests intended for use with human serum or plasma and new specimen types are beyond the scope of this reclassification order.
Comment 4 Several commenters expressed support of FDAs proposal to rename these devices from hepatitis C
virus antibody assay devices to hepatitis C virus HCV antibody tests. These commenters believed that the new name for these devices made clear that these are diagnostic tests and is consistent with the naming of similar diagnostic devices. Alternatively, several commenters provided suggestions on FDAs proposal to rename these devices to hepatitis C
virus HCV antibody tests. One commenter suggested renaming these devices HCV serological tests.
Another commenter suggested renaming these devices hepatitis C virus HCV
antibody test devices.
Response 4 FDA believes that the new identification of these devices as hepatitis C virus HCV antibody tests is both understandable to consumers and industry and is consistent with the naming of similar diagnostic devices.
FDA disagrees with those commenters that proposed renaming these devices HCV serological tests or hepatitis C
virus HCV antibody test devices as FDA believes that the identification of these devices as hepatitis C virus HCV antibody tests adequately identifies the types of devices that would be affected by this reclassification action and is clear and consistent with the naming of similar diagnostic devices.
Comment 5 One commenter suggested that HCV antibody tests could be classified in part 866 21 CFR part 866 after Hepatitis A virus HAV
serological reagents which are currently classified under 21 CFR
866.3310.
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Response 5 FDA disagrees with this comment because FDA believes that the classification of HCV antibody tests under 866.3169 21 CFR 866.3169 is appropriate. In addition, FDA has proposed to reclassify nucleic acidbased HCV ribonucleic acid RNA
devices intended for the qualitative or quantitative detection or genotyping of HCV RNA under 866.3170 21 CFR
866.3170 85 FR 18483. The classification of HCV antibody tests in 866.3169 would allow for these devices to be located next to nucleic acid-based HCV RNA tests in the Code of Federal Regulations CFR.
Comment 6 One commenter requested that FDA state the time that it generally takes for FDA to review 510k submissions and PMA
applications.
Response 6 Review times for a particular device may vary but the FD&C Act requires manufacturers to submit a 510k to FDA at least 90 days before introducing, or before delivering for introduction, a device into interstate commerce see section 510k of the FD&C Act. For comparison, FDA has 180 days to review a PMA starting on the date an application is accepted for filing see section 515d of the FD&C
Act 21 U.S.C. 360ed and 21 CFR
814.40.
Comment 7 One comment indicated a patient who was diagnosed with hepatitis was successfully treated.
Another comment requested that FDA
consider reducing the prices of HCV
antibody tests as a result of their reclassification.
Response 7 Each of these comments are outside the scope of this reclassification action.
Comment 8 Several comments expressed general support of the special controls identified in the proposed order and believed they would provide a reasonable assurance of safety and effectiveness of these devices. In addition, several commenters suggested that FDA revise the special controls to include a requirement that the labeling identify where and when these devices may be used consistent with infection control standards and FDA guidance documents for infection control.
Additionally, it was suggested that the labeling specify the special populations of patients for which test performance may be affected.
Response 8 FDA continues to believe that the special controls identified in the proposed order and finalized in this final order are sufficient to provide a reasonable assurance of safety and effectiveness of HCV
antibody tests.
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FDA disagrees that a further level of specificity is necessary for inclusion within the special controls to provide a reasonable assurance of safety and effectiveness for these devices and wants to ensure that the special controls remain appropriate and applicable to provide a reasonable assurance of safety and effectiveness for these devices over time. Further, performance of these devices may evolve over time for special populations and any special populations for which performance of these devices may be affected are required to be included in the labeling for these devices by the special controls see 866.3169b1iiA.
III. The Final Order Based on the information discussed in the preamble to the proposed order 85
FR 18490, the comments received for the proposed order, the 2018 Panel deliberations Ref. 4, and FDAs experiences over the years in reviewing these device types, FDA concludes that special controls, in conjunction with general controls, will provide a reasonable assurance of the safety and effectiveness of HCV antibody 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 HCV antibody tests intended for the qualitative detection of HCV from class III to class II, and establishing special controls by revising 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 HCV antibody tests.
Therefore, this device type is not exempt from premarket notification requirements. Persons who intend to market a new HCV antibody assay device 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 HCV antibody tests and identified as in vitro diagnostic devices intended for use with human serum,
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