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Federal Register / Vol. 86, No. 222 / Monday, November 22, 2021 / Rules and Regulations confidence interval of greater than or equal to 96 percent.
4 For devices intended for the quantitative detection of HCV RNA, the following special controls, in addition to those listed in paragraphs b1 and 2 of this section, apply:
i Labeling required under 809.10b of this chapter must include a prominent statement that the test is not intended as a diagnostic test to confirm the presence of active HCV infection, when applicable.
ii Design verification and validation must include the following:
A Detailed documentation of the following analytical performance studies conducted as appropriate to the technology, specimen types tested, and intended use of the device, including but not limited to: LoD, ULoQ and LLoQ. LoD, LLoQ, and linearity studies must demonstrate acceptable device performance with all HCV genotypes detected by the device.
B Detailed documentation of clinical performance testing from either:
1 A multisite clinical study with an appropriate number of clinical samples from chronically HCV infected patients in which the results are compared to an FDA-cleared or approved quantitative HCV RNA test, or a comparator that FDA has determined is appropriate.
This study must include a sufficient number of HCV positive samples containing an analyte concentration near the LLoQ to describe performance at this level. Clinical samples must cover the full range of the device output and must be consistent with the distribution of these genotypes in the U.S. population. Clinical samples may be supplemented with diluted clinical samples for those viral load concentrations that are not sufficiently covered by natural clinical specimens, or 2 A clinical study with prospectively collected samples demonstrating clinical validity of the device.
C Detailed documentation of a qualitative analysis near the lower end of the measuring range demonstrating acceptable performance when used as an aid in diagnosis.
5 For devices intended for HCV RNA
genotyping, in addition to the special controls listed in paragraphs b1 and 2 of this section, design verification and validation must include the following:
i Detailed documentation of an analytical performance study demonstrating the LoD for all HCV
genotypes detected by the device.
ii Detailed documentation, including results, of a multisite clinical study that
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assesses genotyping accuracy i.e., the proportion of interpretable results that match with the reference method result and the genotyping rate i.e., the proportion of results that were interpretable.
6 For any nucleic acid-based HCV
RNA test intended for Point of Care PoC use, the following special controls, in addition to those listed in paragraphs b1 and 2 of this section, apply:
i Clinical studies must be conducted at PoC sites.
ii Additional labeling must include a brief summary of the instructions for use that are appropriate for use in a PoC
environment.
Dated: November 16, 2021.
Lauren K. Roth, Associate Commissioner for Policy.
FR Doc. 202125379 Filed 111921; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration 21 CFR Part 866
Docket No. FDA2020N1082

Microbiology Devices; Reclassification of Certain Hepatitis C Virus Antibody Assay Devices, Renamed to Hepatitis C Virus Antibody Tests Food and Drug Administration, Department of Health and Human Services HHS.
ACTION: Final amendment; final order.
AGENCY:

The Food and Drug Administration FDA or the Agency is issuing a final order to reclassify certain hepatitis C virus HCV antibody assay devices intended for the qualitative detection of HCV, postamendments class III devices product code MZO
into class II general controls and special controls, subject to premarket notification. FDA is renaming and codifying these devices under the classification regulation named hepatitis C virus HCV antibody 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:
Maria Ines Garcia, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3104, Silver Spring, SUMMARY:

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MD 209930002, 3017967017, Maria.Garcia@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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 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.1
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 21 CFR part 807, subpart E, of the regulations.
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 1 HCV antibody assay devices for the qualitative detection of HCV with intended uses outside the scope of the classification under 21 CFR 866.3169
are considered postamendments devices that are subject to classification under section 513f1 of the FD&C Act or, if the relevant requirements are met, under section 513f2 of the FD&C Act.

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