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Federal Register / Vol. 86, No. 222 / Monday, November 22, 2021 / Rules and Regulations
860.7c2 21 CFR 860.7c2, in the classification process to determine the level of regulation for devices. To be considered in the reclassification process, the valid scientific evidence upon which the Agency relies must be publicly available see section 520c of the FD&C Act 21 U.S.C. 360jc.
Publicly available information excludes trade secret and/or confidential commercial information, e.g., the contents of a pending premarket approval application PMA see section 520c of the FD&C Act.
FDA published a proposed order in the Federal Register of April 2, 2020 85
FR 18490, to reclassify these device types from class III into class II general controls and special controls, subject to premarket notification. FDA has considered the information available to the Agency, including the deliberations of the March 22, 2018, Microbiology Devices Panel 2018 Panel, and comments from the public docket to determine that there is sufficient information to establish special controls to effectively mitigate the risks to the health identified in section V of the proposed order, and that these special controls, together with general controls, provide a reasonable assurance of safety and effectiveness when applied to certain HCV antibody assay devices intended for the qualitative detection of HCV.
Therefore, in accordance with section 513f3 of the FD&C Act, FDA, on its own initiative, is issuing this final order to reclassify certain HCV antibody assay devices intended for the qualitative detection of HCV from class III to class II general and special controls.2

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II. Comments on the Proposed Order On April 2, 2020, FDA published in the Federal Register a proposed order 85 FR 18490 to reclassify certain HCV
antibody assay devices intended for the qualitative detection of HCV from class III to class II, subject to premarket notification. The comment period on the proposed order closed on June 1, 2020.
In response to the proposed order, FDA
received comments from industry, healthcare associations, public health departments, and individual consumers by the close of the comment period, some of which contained one or more 2 FDA notes that the ACTION caption for this final order is styled as Final amendment; final order, rather than Final order. Beginning in December 2019, this editorial change was made to indicate that the document amends the Code of Federal Regulations. The change was made in accordance with the Office of the Federal Registers OFR interpretation of the Federal Register Act 44
U.S.C. chapter 15, its implementing regulations 1
CFR 5.9 and parts 21 and 22 and the Document Drafting Handbook.

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comments on one or more issues. We describe and respond to the comments in this section of the document. Certain comments are grouped based on common themes; we grouped similar comments together under the same number and listed them numerically.
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 certain HCV antibody assay devices intended for the qualitative detection of HCV 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 certain HCV antibody assay devices for the qualitative detection of HCV 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 expressed concerns about the proposed reclassification of these devices from class III into class II. The commenter suggested that there was not enough justification to reclassify these devices at this time and asked for clarification on FDAs justification proposing this reclassification. The commenter also asked for clarification on whether a high
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demand of these devices was a consideration in FDAs proposed reclassification order.
Response 2 Based on the evidence considered, comments received in response to the proposed order and deliberations of the 2018 Panel, FDA
disagrees with this comment and continues to believe that reclassification of these devices is justified for the reasons identified in the proposed order 85 FR 18490. FDAs justification for reclassifying these devices is based on the unanimous recommendation of the 2018 Panel, FDAs accumulated experience with these devices from review submissions, and from published peer-reviewed literature. In addition, FDA believes that the special controls identified in this final order, in addition to the general controls, will provide a reasonable assurance of the safety and effectiveness of these devices.
FDA relies upon valid scientific evidence as defined in section 513a3 of the FD&C Act and 860.7c2 in the classification process to determine the level of regulation for devices. FDA believes the standard in section 513a1B of the FD&C Act is met as there is sufficient information to establish special controls, which, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of these devices.
While FDA expects that the reclassification of these devices would enable more manufacturers to develop HCV antibody tests such that patients would benefit from increased access to safe and effective tests, this is not a consideration in the Agencys reclassification determination.
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 HCV antibody tests for prescription use and suggested that the reclassification order should also include HCV antibody tests intended for over-the-counter 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 HCV antibody 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 HCV antibody tests that have been previously approved by FDA. FDA
has not approved any HCV antibody tests intended for OTC use and FDA
believes that an HCV antibody tests
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