Document ID: FDA-2020-N-1082-0018
Agency: fda
Document Type: Rule
Title: Microbiology Devices; Reclassification of Certain Hepatitis C Virus Antibody Assay Devices, Renamed to Hepatitis C Virus Antibody Tests
Posted Date: 2021-11-22T05:00Z

[Federal Register Volume 86, Number 222 (Monday, November 22, 2021)]
[Rules and Regulations]
[Pages 66173-66177]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25374]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2020-N-1082]

Microbiology Devices; Reclassification of Certain Hepatitis C 
Virus Antibody Assay Devices, Renamed to Hepatitis C Virus Antibody 
Tests

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

ACTION: Final amendment; final order.

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SUMMARY: 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, MD 20993-0002, 301-
796-7017, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background--Regulatory 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 513(f)(1) 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 513(i) 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 510(k) of the FD&C Act (21 U.S.C. 
360(k)) and part 807 (21 CFR part 807), subpart E, of the regulations.
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    \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 513(f)(1) of the FD&C Act 
or, if the relevant requirements are met, under section 513(f)(2) of 
the FD&C Act.
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    A postamendments device that has been initially classified in class 
III under section 513(f)(1) of the FD&C Act may be reclassified into 
class I or II under section 513(f)(3) of the FD&C Act. Section 
513(f)(3) 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 513(a)(3) of the FD&C Act and

[[Page 66174]]

Sec.  860.7(c)(2) (21 CFR 860.7(c)(2)), 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 520(c) 
of the FD&C Act (21 U.S.C. 360j(c))). Publicly available information 
excludes trade secret and/or confidential commercial information, e.g., 
the contents of a pending premarket approval application (PMA) (see 
section 520(c) 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 513(f)(3) 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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    \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 Register's (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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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 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 comment's 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 
FDA's justification proposing this reclassification. The commenter also 
asked for clarification on whether a high demand of these devices was a 
consideration in FDA's 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). FDA's justification for 
reclassifying these devices is based on the unanimous recommendation of 
the 2018 Panel, FDA's 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 
513(a)(3) of the FD&C Act and Sec.  860.7(c)(2) in the classification 
process to determine the level of regulation for devices. FDA believes 
the standard in section 513(a)(1)(B) 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 Agency's 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 FDA's 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 FDA's 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

[[Page 66175]]

intended for OTC use would be a new type of device not previously 
classified based on the criteria at section 513(a)(1) of the FD&C Act 
and, as a result, such postamendments devices would be automatically 
classified into class III by operation of section 513(f)(1) 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 
513(f)(2) 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 FDA's 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 FDA's 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.
    (Response 5) FDA disagrees with this comment because FDA believes 
that the classification of HCV antibody tests under Sec.  866.3169 (21 
CFR 866.3169) is appropriate. In addition, FDA has proposed to 
reclassify nucleic acid-based HCV ribonucleic acid (RNA) devices 
intended for the qualitative or quantitative detection or genotyping of 
HCV RNA under Sec.  866.3170 (21 CFR 866.3170) (85 FR 18483). The 
classification of HCV antibody tests in Sec.  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 510(k) submissions and PMA 
applications.
    (Response 6) Review times for a particular device may vary but the 
FD&C Act requires manufacturers to submit a 510(k) to FDA at least 90 
days before introducing, or before delivering for introduction, a 
device into interstate commerce (see section 510(k) 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 515(d) of the FD&C 
Act (21 U.S.C. 360e(d)) 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.
    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 Sec.  
866.3169(b)(1)(ii)(A)).

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 FDA's 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 513(f)(3) 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 
513(a)(1)(B) of the FD&C Act that, together with general controls, 
provide a reasonable assurance of the safety and effectiveness of these 
devices.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class 
II device from the premarket notification requirements under section 
510(k) 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,

[[Page 66176]]

plasma, or other matrices as a prescription device that aids in the 
diagnosis of HCV infection in persons with signs and symptoms of 
hepatitis and in persons at risk for hepatitis C infection. The test is 
not intended for screening blood, plasma, cell, or tissue donors.
    Under this final order, HCV antibody tests are identified as 
prescription use only devices and as such, HCV antibody tests must 
satisfy prescription labeling requirements for in vitro diagnostic 
products (see 21 CFR 809.10(a)(4) and (b)(5)(ii)). Under 21 CFR 807.81, 
the device continues to be subject to 510(k) requirements.

IV. Codification of Orders

    Prior to the amendments in the Food and Drug Administration Safety 
and Innovation Act (Pub. L. 112-144) (FDASIA), section 513(e) of the 
FD&C Act provided for FDA to issue regulations to reclassify devices. 
Although section 513(e), as amended by FDASIA, requires FDA to issue 
final orders rather than regulations, it also provides for FDA to 
revoke previously issued regulations by order. FDA will continue to 
codify classifications and reclassifications in the CFR. Changes 
resulting from final orders will appear in the CFR as changes to 
codified classification determinations or as newly codified orders. 
Therefore, under section 513(e)(1)(A)(i), as amended by FDASIA, in this 
final order, we are proposing to codify the classification of hepatitis 
c virus antibody tests in the new Sec.  866.3169, under which HCV 
antibody tests would be reclassified into class II.

V. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VI. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to 
previously approved FDA collections. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The 
collections of information in part 807, subpart E have been approved 
under OMB control number 0910-0120; the collections of information in 
21 CFR parts 801 and 809 have been approved under OMB control number 
0910-0485; and the collections of information in 21 CFR part 820 have 
been approved under OMB control number 0910-0073.

VII. References

    The following references are on display at the Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852, 240-402-7500 and are available for viewing 
by interested persons between 9 a.m. and 4 p.m., Monday through Friday; 
they also are available electronically at https://www.regulations.gov. 
FDA has verified the website addresses, as of the date this document 
publishes in the Federal Register, but websites are subject to change 
over time.

1. ``De Novo Classification Process (Evaluation of Automatic Class 
III Designation)--Guidance for Industry and Food and Drug 
Administration Staff,'' issued October 30, 2017 (available at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/de-novo-classification-process-evaluation-automatic-class-iii-designation).
2. ``Acceptance Review for De Novo Classification Requests--Guidance 
for Industry and Food and Drug Administration Staff,'' issued 
September 9, 2019 (available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-review-de-novo-classification-requests).
3. ``Requests for Feedback and Meetings for Medical Device 
Submissions: The Q-Submission Program--Guidance for Industry and 
Food and Drug Administration Staff,'' issued May 7, 2019 (available 
at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program).
4. Transcript of the FDA Microbiology Devices Panel Meeting, March 
22, 2018 (available at https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/UCM630139.pdf).

List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
866 is amended as follows:

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

0
1. The authority citation for part 866 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  866.3169 to subpart D to read as follows:

Sec.  866.3169   Hepatitis C virus antibody tests.

    (a) Identification. A hepatitis C virus (HCV) antibody test is 
identified as an in vitro diagnostic device intended for use with human 
serum, plasma, or other matrices as a prescription device that aids in 
the diagnosis of HCV infection in persons with signs and symptoms of 
hepatitis and in persons at risk for hepatitis C infection. The test is 
not intended for screening blood, plasma, cell, or tissue donors.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The labeling required under Sec.  809.10(b) of this chapter 
must include:
    (i) A prominent statement that the test is not intended for the 
screening of blood, plasma, and cell or tissue donors.
    (ii) Limitations, which must be updated to reflect current clinical 
practice and disease presentation and management. The limitations must 
include, but are not limited to, statements that indicate:
    (A) When appropriate, the performance characteristics of the test 
have not been established in populations of immunocompromised or 
immunosuppressed patients or, other special populations where test 
performance may be affected.
    (B) The detection of HCV antibodies indicates a present or past 
infection with hepatitis C virus, but does not differentiate between 
acute, chronic, or resolved infection.
    (C) The specimen types for which the device has been cleared, and 
that use of the test with specimen types other than those specifically 
cleared for this device may result in inaccurate test results.
    (D) Test results are to be interpreted by qualified licensed 
healthcare professionals in conjunction with the individual's clinical 
presentation, history, and other laboratory results.
    (E) A non-reactive test result may occur early during acute 
infection, prior to development of a host antibody response to 
infection, or when analyte levels are below the limit of detection of 
the test.
    (iii) A detailed explanation of the principles of operation and 
procedures for performing the test.
    (2) Design verification and validation must include the following:
    (i) A detailed device description, including all parts that make up 
the device, ancillary reagents required but not provided, an 
explanation of the device methodology, and design of the antigen(s) and 
capture antibody(ies)

[[Page 66177]]

sequences, rationale for the selected epitope(s), degree of amino acid 
sequence conservation of the target, and the design and nature of all 
primary, secondary, and subsequent standards used for calibration.
    (ii) Documentation and characterization (e.g., supplier, 
determination of identity, and stability) of all critical reagents 
(including description of the antigen(s) and capture antibody(ies)), 
and protocols for maintaining product integrity throughout its labeled 
shelf life.
    (iii) Risk analysis and management strategies, such as Failure 
Modes Effects Analysis and/or Hazard Analysis and Critical Control 
Points summaries and their impact on test performance.
    (iv) Final release criteria to be used for manufactured test lots 
with appropriate evidence that lots released at the extremes of the 
specifications will meet the claimed analytical and clinical 
performance characteristics as well as the stability claims.
    (v) Stability studies for reagents must include documentation of an 
assessment of real-time stability for multiple reagent lots using the 
indicated specimen types and must use acceptance criteria that ensure 
that analytical and clinical performance characteristics are met when 
stability is assigned based on the extremes of the acceptance range.
    (vi) All stability protocols, including acceptance criteria.
    (vii) Final release test results for each lot used in clinical 
studies.
    (viii) Multisite reproducibility study that includes the testing of 
three independent production lots.
    (ix) Analytical performance studies and results for determining the 
limit of blank (LoB), limit of detection (LoD), cutoff, precision 
(reproducibility) including lot-to-lot and/or instrument-to-instrument 
precision, interference, cross reactivity, carryover, hook effect, 
seroconversion panel testing, matrix equivalency, specimen stability, 
reagent stability, and cross-genotype antibody detection sensitivity, 
when appropriate.
    (x) Analytical sensitivity of the test is the same or better than 
that of other cleared or approved tests.
    (xi) Detailed documentation of clinical performance testing from a 
multisite clinical study. Performance must be analyzed relative to an 
FDA cleared or approved HCV antibody test, or a comparator that FDA has 
determined is appropriate. This study must be conducted using 
appropriate patient samples, with an acceptable number of HCV positive 
and negative samples in applicable risk categories. Additional relevant 
patient groups must be validated as appropriate. The samples may be a 
combination of fresh and repository samples, sourced from 
geographically diverse areas. The study designs, including number of 
samples tested, must be sufficient to meet the following criteria:
    (A) Clinical sensitivity of the test must have a lower bound of the 
95 percent confidence interval of greater than or equal to 95 percent.
    (B) Clinical specificity of the test must have a lower bound of the 
95 percent confidence interval of greater than or equal to 96 percent.
    (3) For any HCV antibody test intended for Point of Care (PoC) use, 
the following special controls, in addition to those listed in 
paragraphs (b)(1) 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. 2021-25374 Filed 11-19-21; 8:45 am]
BILLING CODE 4164-01-P