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Federal Register / Vol. 86, No. 222 / Monday, November 22, 2021 / Rules and Regulations Robert F. Altneu, Director, Regulations & Disclosure Law Division, Regulations & Rulings, Office of Trade U.S. Customs and Border Protection.
Approved: November 17, 2021.
Timothy E. Skud, Deputy Assistant Secretary of the Treasury.
FR Doc. 202125384 Filed 111921; 8:45 am BILLING CODE 911114P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration 21 CFR Part 866
Docket No. FDA2020N1088

Microbiology Devices; Reclassification of Nucleic Acid-Based Hepatitis C
Virus Ribonucleic Acid Assay Devices, Renamed to Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Tests AGENCY:

Food and Drug Administration,
HHS.
ACTION:

Final amendment; final order.

The Food and Drug Administration FDA or the Agency is issuing a final order to reclassify nucleic acid-based hepatitis C virus HCV
ribonucleic acid RNA devices intended for the qualitative or quantitative detection or genotyping of HCV RNA, postamendments class III
devices product codes MZP and OBF, into class II general controls and special controls, subject to premarket notification. FDA is renaming and codifying these devices under the classification regulation named nucleic acid-based hepatitis C virus HCV
ribonucleic acid tests. FDA is also identifying the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of these devices.
DATES: This order is effective December 22, 2021.
FOR FURTHER INFORMATION CONTACT:
Silke Schlottmann, Division of Microbiology Devices, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3258, Silver Spring, MD 209930002, 301
7969551, Silke.Schlottmann@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:

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SUMMARY:

I. BackgroundRegulatory Authorities The Federal Food, Drug, and Cosmetic Act FD&C Act, as amended, establishes a comprehensive system for the regulation of medical devices intended
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for human use. Section 513 of the FD&C
Act 21 U.S.C. 360c established three classes of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three classes of devices are class I general controls, class II general and special controls, and class III general controls and premarket approval.
Devices that were not in commercial distribution prior to May 28, 1976
generally referred to as postamendments devices, are automatically classified by section 513f1 of the FD&C Act into class III
without any FDA rulemaking process.
Those devices remain in class III and require premarket approval unless, and until: 1 FDA reclassifies the device into class I or II or 2 FDA issues an order finding the device to be substantially equivalent, in accordance with section 513i of the FD&C Act, to a predicate device that does not require premarket approval. FDA determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510k of the FD&C Act 21 U.S.C. 360k and part 807, subpart E 21 CFR part 807, subpart E.
A postamendments device that has been initially classified in class III
under section 513f1 of the FD&C Act may be reclassified into class I or II
under section 513f3 of the FD&C Act.
Section 513f3 of the FD&C Act provides that FDA, acting by administrative order, can reclassify the device into class I or II on its own initiative, or in response to a petition from the manufacturer or importer of the device. To change the classification of the device, the proposed new class must have sufficient regulatory controls to provide a reasonable assurance of the safety and effectiveness of the device for its intended use.
FDA relies upon valid scientific evidence, as defined in section 513a3 of the FD&C Act and 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 18483, to reclassify nucleic acid-

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based HCV RNA devices intended for the qualitative or quantitative detection or genotyping of HCV RNA, postamendment class III devices, 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 and has determined that there is sufficient information to establish special controls to effectively mitigate the risks to 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 nucleic acid-based HCV RNA devices intended for the qualitative or quantitative detection or genotyping of HCV RNA.
Therefore, in accordance with section 513f3 of the FD&C Act, FDA, on its own initiative, 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 general and special controls.1
II. Comments on the Proposed Order On April 2, 2020, FDA published in the Federal Register a proposed 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, 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 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.
1 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 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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