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Federal Register / Vol. 86, No. 222 / Monday, November 22, 2021 / Rules and Regulations
The order of response to the commenters is purely for organizational purposes and does not signify the comments value or importance nor the order in which comments were received. Please note that in some cases we separated different issues discussed by the same commenter and designated them as distinct comments for purposes of our responses.
Comment 1 FDA received numerous comments in favor of the proposed reclassification of nucleic acid-based HCV RNA devices intended for the qualitative or quantitative detection or genotyping of HCV RNA from class III
to class II with special controls.
Commenters stated they believed that special controls, along with general controls, could provide a reasonable assurance of the safety and effectiveness of these devices. In addition, they believed that the decreased regulatory burden resulting from the reclassification could encourage further development of, and provide patients more timely access to, these devices.
Overall, there was a general consensus among the commenters that the proposed special controls are necessary and sufficient to mitigate the risks to health of patients presented by these devices and to provide reasonable assurance of the safety and effectiveness of these devices.
Response 1 Based on the evidence considered, comments received in response to the proposed order, and deliberations of the 2018 Panel, FDA
agrees with the commenters that reclassification of nucleic acid-based HCV RNA devices for the qualitative or quantitative detection or genotyping of HCV RNA from class III into class II and that special controls, in addition to general controls, can provide a reasonable assurance of the safety and effectiveness of these devices. In addition, FDA expects that the reclassification of these devices would enable more manufacturers to develop them such that patients would benefit from increased access to safe and effective tests.
Comment 2 One comment objected to the proposed reclassification of these devices from class III into class II on the basis that the commenter was not provided adequate notification of the proposed reclassification.
Response 2 FDA disagrees with this comment as FDA provided notice of our proposed reclassification of these devices with the publication of the proposed order in the Federal Register on April 2, 2020, in accordance with section 513f3 of the FD&C Act and 21
CFR part 860. In addition, as discussed further in the proposed order, a public
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meeting of the 2018 Panel was held where FDA discussed the possible reclassification of nucleic acid-based HCV RNA tests and the Panel members agreed unanimously with the proposal.
Comment 3 Several commenters had questions about the scope of the proposed reclassification order. Several commenters noted that the proposed reclassification order identified these devices as nucleic-acid based HCV RNA
tests for prescription use and suggested that the reclassification order should also include tests intended for over-thecounter OTC use. In addition, one commenter suggested that FDAs reclassification order should also include HCV antigen tests, tests for hepatitis A and hepatitis B, and also that the reclassification should include other specimen types for nucleic acidbased HCV RNA tests beyond those identified in the proposed order e.g., urine or saliva.
Response 3 These comments are beyond the scope of FDAs proposed reclassification order, which applies only to nucleic acid-based HCV RNA
tests that have been previously approved by FDA. FDA has not approved any nucleic acid-based HCV
RNA tests intended for OTC use, and FDA believes that a nucleic acid-based HCV RNA test 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 device would be automatically classified into class III by operation of section 513f1 of the FD&C Act.
Similarly, to date, FDA has only approved nucleic acid-based HCV RNA
tests intended for use with human serum or plasma, and new specimen types are beyond the scope of FDAs proposed reclassification order.
Comment 4 Several commenters expressed support of FDAs proposal to rename these devices from nucleic acid-based hepatitis C virus HCV
ribonucleic acid RNA assay devices to nucleic acid-based hepatitis C virus HCV ribonucleic acid RNA 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.
Response 4 FDA believes that the new identification name of these devicesnucleic acid-based hepatitis C virus HCV ribonucleic acid RNA
testsis both understandable to consumers and industry and is consistent with the naming of similar diagnostic devices and agrees with these commenters. As discussed further below
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in section III, FDA on its own initiative has revised the device identification of nucleic-acid based HCV RNA to be codified in 866.3170a 21 CFR
866.3170a.
Comment 5 One commenter suggested that the proposed special control requiring cross-reactivity studies may not be necessary and suggested instead that interfering substance studies be conducted according to CLSIEP7A2: Interference Testing in Clinical Chemistry: Approved GuidelineSecond Edition Ref. 1.
Response 5 FDA disagrees with this comment and believes that the special control requiring cross-reactivity studies that include samples from HCV RNA
negative subjects with other causes of liver disease, including autoimmune hepatitis, alcoholic liver disease, chronic hepatitis B virus, primary biliary cirrhosis, and nonalcoholic steatohepatitis, when applicable, is necessary to provide a reasonable assurance of the safety and effectiveness of these devices see 866.3170b2iv. FDA also believes that specifying a standard explicitly as part of the special controls that manufacturers must follow is not necessary and would prohibit the use of a new standard in the event that the version of the standard specified in the special controls is revised and/or updated.
Comment 6 One commenter suggested that FDA provide additional details regarding the study design and analysis required for devices intended for the quantitative detection of HCV
RNA by the special control in 866.3170b4C. In addition, the commenter requested clarification on the requirement for clinical studies for nucleic-acid based HCA RNA tests intended for Point of Care PoC use and inquired whether the sample size for such studies should be larger than for the other clinical studies required by the special controls.
Response 6 FDA disagrees with this comment and does not believe that additional specificity is required to provide a reasonable assurance of the safety and effectiveness of these devices because the appropriate sample size for a required study may be influenced by the technology at issue and/or type of device under review.
FDA recommends that device manufacturers interested in obtaining FDA feedback on their study design submit a pre-submission Ref. 2. In addition, FDA publishes our decision summaries for previously approved or cleared devices for in vitro diagnostic testing on our website and these summaries can be useful aids for
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