[Federal Register Volume 87, Number 213 (Friday, November 4, 2022)]
[Rules and Regulations]
[Pages 66545-66549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23868]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2020-N-2297]


Microbiology Devices; Reclassification of Human Immunodeficiency 
Virus Viral Load Monitoring Tests

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
issuing a final order to reclassify human immunodeficiency virus (HIV) 
viral load monitoring tests, postamendments class III devices with the 
product code MZF, into class II (special controls), subject to 
premarket notification. Through this final order, FDA is also adding a 
new device classification regulation along with special controls that 
are necessary to provide a reasonable assurance of safety and 
effectiveness for this device type. The final order reclassifies this 
device type from class III (premarket approval) to class II (special 
controls) and will reduce the regulatory burdens associated with these 
devices because manufacturers will no longer be required to submit a 
premarket approval application (PMA) for this device type but can 
instead submit a less burdensome premarket notification (510(k)) and 
receive clearance before marketing their device.

DATES: This order is effective December 5, 2022.

FOR FURTHER INFORMATION CONTACT: Myrna Hanna, Center for Biologics 
Evaluation and Review, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 72, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by 
the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 
94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the 
Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-
115), the Medical Device User Fee and Modernization Act of 2002 (Pub. 
L. 107-250), the Medical Devices Technical Corrections Act (Pub. L. 
108-214), the Food and Drug Administration Amendments Act of 2007 (Pub. 
L. 110-85), and the Food and Drug Administration Safety and Innovation 
Act (Pub. L. 112-144), among other amendments, 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 categories (classes) of devices, reflecting the regulatory 
controls needed to provide reasonable assurance of their safety and 
effectiveness. The three categories of devices are class I (general 
controls), class II (general controls and special controls), and class 
III (general controls and premarket approval).
    Section 513(a)(1) of the FD&C Act defines the three classes of 
devices. Class I devices are those devices for which the general 
controls of the FD&C Act (controls authorized by or under sections 501, 
502, 510, 516, 518, 519, or 520 (21 U.S.C. 351, 352, 360, 360f, 360h, 
360i, or 360j) or any combination of such sections) are sufficient to 
provide reasonable assurance of safety and effectiveness; or those 
devices for which insufficient information exists to determine that 
general controls are sufficient to provide reasonable assurance of 
safety and effectiveness or to establish special controls to provide 
such assurance, but because the devices are not purported or 
represented to be for a use in supporting or sustaining human life or 
for a use which is of substantial importance in preventing impairment 
of human health, and do not present a potential unreasonable risk of 
illness or injury, are to be regulated by general controls (section 
513(a)(1)(A) of the FD&C Act). Class II devices are those devices for 
which general controls by themselves are insufficient to provide 
reasonable assurance of safety and effectiveness and for which there is 
sufficient information to establish special controls to provide such 
assurance, including the promulgation of performance standards, 
postmarket surveillance, patient registries, development and 
dissemination of guidelines, recommendations, and other appropriate 
actions the Agency deems necessary to provide such assurance (section 
513(a)(1)(B) of the FD&C Act). Class III devices are those devices for 
which insufficient information exists to determine that general 
controls and special controls would provide a reasonable assurance of 
safety and effectiveness, and are purported or represented to be for a 
use in supporting or sustaining human life or for a use which is of 
substantial importance in preventing impairment of human health, or 
present a potential unreasonable risk of illness or injury (section 
513(a)(1)(C) of the FD&C Act).
    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. Those devices remain in 
class III and require premarket approval unless, and until: (1) FDA 
reclassifies the device into class I or class 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 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 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 class 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

[[Page 66546]]

safety and effectiveness of the device for its intended use.
    In the Federal Register of November 24, 2021 (86 FR 66982), FDA 
published a proposed order to reclassify HIV viral load monitoring 
tests from class III to class II (special controls), subject to 
premarket notification. The comment period on the proposed order closed 
on January 24, 2022.

II. Comments on the Proposed Order

    In response to the November 24, 2021, proposed order, FDA received 
three comments (two comments from public health organizations and one 
comment from a device manufacturer) by the close of the comment period, 
each containing one or more comments on one or more issues. We describe 
and respond to the comments in this section of the document. 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 the comments were received.
    (Comment 1) All three commenters expressed general support for the 
proposed reclassification and proposed special controls.
    (Response 1) We acknowledge and appreciate the supportive comments. 
In this final order, we are reclassifying HIV viral load monitoring 
tests into class II and establishing the special controls published in 
the proposed order (86 FR 66982) without modifications except for minor 
editorial changes. See Section III, below, for a summary of the final 
order.
    (Comment 2) One commenter requested that FDA provide more detail 
regarding the application in various analytical studies of the proposed 
requirement under Sec.  866.3958(b)(2)(iii) (21 CFR 
866.3958(b)(2)(iii)) that ``[s]amples selected for use in analytical 
studies or used to prepare samples for use in analytical studies must 
be from subjects with clinically relevant genotypes circulating in the 
United States.''
    (Response 2) FDA does not agree that additional detail is necessary 
to describe the requirement under Sec.  866.3958(b)(2)(iii). The 
requirement to use or prepare samples from subjects with clinically 
relevant genotypes circulating in the United States is intended to 
ensure that the device will detect HIV genotypes that are of clinical 
concern at the time the device is cleared. How this requirement should 
be implemented for a particular analytical study would depend on other 
details regarding study design, the specific device at issue, and the 
currently circulating genotypes in the United States. Therefore, it is 
not practical to describe how this requirement would apply for all 
future analytical studies of HIV viral load monitoring tests in this 
final order. If the developer of an HIV viral load monitoring test 
seeks feedback about the design of an analytical study specific to the 
developer's device, such feedback can be provided through the Q-
submission program.\1\
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    \1\ FDA has issued guidance for submitters on the Q-submission 
program. See ``Requests for Feedback and Meetings for Medical Device 
Submissions: The Q-Submission Program; Guidance for Industry and 
Food and Drug Administration Staff'' dated January 6, 2021, 
available at https://www.fda.gov/media/114034/download.
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    (Comment 3) One commenter addressed proposed Sec.  
866.3958(b)(2)(v) and agreed with the requirement that ``[s]amples 
tested to demonstrate analytical specificity must include appropriate 
numbers and types of samples from patients with underlying illness and 
infection. . . .'' With respect to the requirement under proposed Sec.  
866.3958(b)(2)(v) that samples tested to demonstrate analytical 
specificity ``include appropriate numbers and types of samples . . . 
from patients with potential interfering substances[,]'' the commenter 
suggested that there be an option to test the effect of specific 
interfering substances ``in accordance to [sic] CLSI EP07--Interference 
Testing in Clinical Chemistry; Ed 3. Approved Guideline.'' The 
commenter added that, ``[i]n this case both HIV-1 positive and HIV-1 
negative specimens would be spiked with each potentially interfering 
substance (endogenous and exogenous) and tested in the investigational 
device.''
    (Response 3) We agree with the comment that in some circumstances, 
a combination of clinical and spiked samples is appropriate based on 
the study goals and design, as discussed in EP07. The special control 
provision at Sec.  866.3958(b)(2)(v) does not preclude this 
possibility. FDA believes that studies conducted to meet the 
requirements under Sec.  866.3958(b)(2)(v) should use clinical samples 
to the extent possible because spiked samples may not mimic natural 
samples from individuals. We encourage device developers to consult the 
study designs and recommendations in the FDA recognized voluntary 
consensus standard EP07, Interference Testing in Clinical Chemistry, 
3rd Ed. (see https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/detail.cfm?standard__identification_no=37749).
    (Comment 4) One commenter requested that FDA clarify the meaning of 
``production lots'' in Sec.  866.3958(b)(2)(iv), which requires that 
device verification and validation include a ``[m]ultisite 
reproducibility study that includes the testing of three independent 
production lots.'' Specifically, the commenter asked if ``these [could] 
be premarket lots, which are equivalent to what would be 
commercialized''.
    (Response 4) FDA believes the language in Sec.  866.3958(b)(2)(iv) 
is sufficiently clear on this issue. The phrase ``three independent 
production lots'' means three lots of the finished device, where the 
lots are produced independently of each other. While the three 
independent lots may be produced in a premarket validation run, the 
devices must be manufactured by a process equivalent to that for the 
devices that will be commercialized.
    (Comment 5) Two commenters recommended harmonizing reclassification 
of HIV viral load monitoring tests with the proposed reclassification 
of HIV diagnostic and supplemental tests and indicated that doing so 
could encourage development of or reduce barriers to marketing devices 
intended for use in both monitoring and diagnosis. Another comment 
recommended that FDA align the special controls for HIV tests with the 
requirements for HCV nucleic acid (NAT) tests in the final 
reclassification order ``Microbiology Devices; Reclassification of 
Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Assay Devices, To 
Be Renamed Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid 
Tests'' (Docket No. FDA-2020-N-1088; April 2, 2020; 86 FR 66169).
    (Response 5) Where appropriate, the special controls for HIV viral 
load monitoring tests in Sec.  866.3958 are aligned with the special 
controls for HIV NAT diagnostic and/or supplemental tests in 21 CFR 
866.3957, which were established in a final order published May 16, 
2022 (Microbiology Devices: Reclassification of Human Immunodeficiency 
Virus Serological Diagnostic and Supplemental Tests and Human 
Immunodeficiency Virus Nucleic Acid Diagnostic and Supplemental Tests, 
87 FR 29661). However, although a test may use the same technology for 
two different intended uses, e.g., use of NAT tests as an aid in 
diagnosis of HIV infection and for viral load monitoring, the risks of 
a false negative result from a diagnostic test are not identical to and 
are potentially greater than the risks of a false negative result of a 
viral load test. For example, an individual living with HIV whose viral 
load is being monitored

[[Page 66547]]

is under the care of a healthcare provider. In this instance, the risk 
of an incorrect result may be mitigated by clinical oversight. However, 
an individual undergoing diagnostic testing may have no signs or 
symptoms of infection, and one risk of an incorrect result is that they 
may be lost to care altogether. FDA is committed to working with 
manufacturers seeking clearance of a device for both intended uses 
using a least-burdensome approach.\2\
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    \2\ See ``The Least Burdensome Provisions: Concepts and 
Principles; Guidance for Industry and Food and Drug Administration 
Staff'' (February 5, 2019), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/least-burdensome-provisions-concept-and-principles.
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    With respect to the comment regarding alignment of special controls 
for HIV tests with those finalized for nucleic acid-based HCV 
ribonucleic acid (RNA) tests, we note that the special controls 
necessary to provide reasonable assurance of safety and effectiveness 
of an in vitro diagnostic device are based on, among other things, the 
specific analyte measured, the disease or condition for which the 
particular device is intended to be used in diagnosis, and the 
conditions of use. This means that the special controls may vary 
between devices that measure different analytes (e.g., HIV and HCV) or 
with different conditions of use (e.g., point of care versus lab-based) 
because the risks associated with each device are different. FDA has 
determined that the special controls identified in the proposed order 
are, together with general controls, sufficient to provide reasonable 
assurance of safety and effectiveness for HIV viral load monitoring 
tests. Therefore, FDA is finalizing those special controls in this 
order without making changes to align them further with those for 
nucleic acid-based HCV RNA tests.
    To the extent the comment addresses alignment of special controls 
for HIV diagnostic and supplemental tests with those for nucleic acid-
based HCV RNA tests, the comment is outside of the scope of this final 
order. For a discussion of comments received on FDA's proposed special 
controls for HIV NAT diagnostic and supplemental tests and HIV 
serological diagnostic and supplemental tests, please refer to the 
final order, ``Microbiology Devices; Reclassification of Human 
Immunodeficiency Virus Serological Diagnostic and Supplemental Tests 
and Human Immunodeficiency Virus Nucleic Acid Diagnostic and 
Supplemental Tests'' (Docket No. FDA-2019-N-5192; May 16, 2022; 87 FR 
29661).

III. Final Order

    Based on the information discussed in the preamble to the proposed 
order (86 FR 66982), the comments received on the proposed order, and 
FDA's experience over the years with this device type, FDA concludes 
that special controls, in conjunction with general controls, will 
provide reasonable assurance of the safety and effectiveness of HIV 
viral load monitoring 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 HIV viral load 
monitoring tests from class III into class II and to establish special 
controls that will be codified at Sec.  866.3958.\3\ In this final 
order, the Agency has identified special controls under section 
513(a)(1)(B) of the FD&C Act which, together with general controls, 
provide a reasonable assurance of the safety and effectiveness of HIV 
viral load monitoring tests. FDA is reclassifying these devices and 
establishing special controls as published in the proposed order (86 FR 
66982) with minor editorial changes for clarity in Sec.  866.3958(a), 
(b)(1)(iii), and (b)(2)(vii).
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    \3\ 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. This change was made in accordance with the Office of 
Federal Register's (OFR) interpretations 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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    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 HIV viral load monitoring tests. Therefore, 
this device type is not exempt from premarket notification 
requirements. Persons who intend to market HIV viral load monitoring 
tests must submit and obtain clearance of a premarket notification and 
demonstrate compliance with the special controls in this final order, 
prior to marketing the device.
    The devices that are the subject of this reclassification are 
assigned the generic name ``human immunodeficiency virus (HIV) viral 
load monitoring tests''. HIV viral load monitoring tests are identified 
as in vitro diagnostic prescription devices for the quantitation of the 
amount of HIV RNA in human body fluids. HIV viral load monitoring tests 
are intended for use in the clinical management of individuals living 
with HIV and are for professional use only. These devices are not 
intended for use as an aid in diagnosis or for screening donors of 
blood or blood products or human cells, tissues, or cellular and 
tissue-based products (HCT/Ps).
    Under this final order, the HIV viral load monitoring tests are 
identified as prescription use only devices. As such, these 
prescription devices must satisfy prescription labeling requirements 
for in vitro diagnostic products (see 21 CFR 809.10(a)(4) and 
(b)(5)(ii)). A premarket notification submission for these devices will 
be required in the circumstances described in 21 CFR 807.81.

IV. Codification of Orders

    Under section 513(f)(3) of the FD&C Act, FDA may issue final orders 
to reclassify devices. FDA will continue to codify classifications and 
reclassifications in the Code of Federal Regulations (CFR). Changes 
resulting from final orders will appear in the CFR as newly codified 
orders. In accordance with section 513(f)(3) of the FD&C Act, we are 
codifying in this final order the classification of HIV viral load 
monitoring tests in the new Sec.  866.3958, under which these devices 
are reclassified from class III to 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

    FDA concludes that this final order contains no new collection of 
information. Therefore, clearance by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 
3501-3521) is not required.
    This final order refers to previously approved FDA collections of 
information. These collections of information are subject to review by 
the OMB under the PRA. The collections of information in part 807, 
subpart E, regarding premarket notification submissions have been 
approved under OMB control number 0910-0120; the collections of 
information in 21 CFR part 820 have been approved under OMB control 
number 0910-0073; the

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collections of information in 21 CFR part 803 have been approved under 
OMB control number 0910-0437; and the collections of information in 21 
CFR parts 801 and 809 have been approved under OMB control number 0910-
0485.

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.  866.3958 to subpart D to read as follows:


Sec.  866.3958   Human immunodeficiency virus (HIV) viral load 
monitoring test.

    (a) Identification. A human immunodeficiency virus (HIV) viral load 
monitoring test is an in vitro diagnostic prescription device for the 
quantitation of the amount of HIV ribonucleic acid (RNA) in human body 
fluids. The test is intended for use in the clinical management of 
individuals living with HIV and is for professional use only. The test 
results are intended to be interpreted in conjunction with other 
relevant clinical and laboratory findings. The test is not intended to 
be used as an aid in diagnosis or for screening donors of blood or 
blood products or human cells, tissues, or cellular and tissue-based 
products (HCT/Ps).
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The labeling must include:
    (i) An intended use that states that the device is not intended for 
use as an aid in diagnosis or for use in screening donors of blood or 
blood products, or HCT/Ps.
    (ii) A detailed explanation of the principles of operation and 
procedures used for assay performance.
    (iii) A detailed explanation of the interpretation of results and 
that recommended actions should be based on current clinical 
guidelines.
    (iv) Limitations, which must be updated to reflect current clinical 
practice and patient management. The limitations must include, but are 
not limited to, statements that indicate:
    (A) The matrices and sample types with which the device has been 
cleared and that use of this test with specimen types other than those 
specifically cleared for this device may cause inaccurate test results.
    (B) Mutations in highly conserved regions may affect binding of 
primers and/or probes resulting in the under-quantitation of virus or 
failure to detect the presence of virus.
    (C) All test results should be interpreted in conjunction with the 
individual's clinical presentation, history, and other laboratory 
results.
    (2) Device verification and validation must include:
    (i) Detailed device description, including the device components, 
ancillary reagents required but not provided, and an explanation of the 
device methodology. Additional information appropriate to the 
technology must be included, such as detailed information on the design 
of primers and probes.
    (ii) For devices with assay calibrators, the design and nature of 
all primary, secondary, and subsequent quantitation standards used for 
calibration as well as their traceability to a reference material. In 
addition, analytical testing must be performed following the release of 
a new lot of the standard material that was used for device clearance, 
or when there is a transition to a new calibration standard.
    (iii) Detailed documentation of analytical performance studies 
conducted as appropriate to the technology, specimen types tested, and 
intended use of the device, including but not limited to, limit of 
blank, limit of detection, limit of quantitation, cutoff determination, 
precision, linearity, endogenous and exogenous interferences, cross-
reactivity, carry-over, quality control, matrix equivalency, sample and 
reagent stability. Samples selected for use in analytical studies or 
used to prepare samples for use in analytical studies must be from 
subjects with clinically relevant genotypes circulating in the United 
States.
    (iv) Multisite reproducibility study that includes the testing of 
three independent production lots.
    (v) Analytical sensitivity of the device must demonstrate 
acceptable performance at current clinically relevant medical decision 
points. Samples tested to demonstrate analytical sensitivity must 
include appropriate numbers and types of samples, including real 
clinical samples near the lower limit of quantitation and any 
clinically relevant medical decision points. Analytical specificity of 
the device must demonstrate acceptable performance. Samples tested to 
demonstrate analytical specificity must include appropriate numbers and 
types of samples from patients with different underlying illnesses and 
infection and from patients with potential interfering substances.
    (vi) Detailed documentation of performance from a multisite 
clinical study or a multisite analytical method comparison study.
    (A) For devices evaluated in a multisite clinical study, the study 
must use specimens from individuals living with HIV being monitored for 
changes in viral load, and the test results must be compared to the 
clinical status of the patients.
    (B) For tests evaluated in a multisite analytical method comparison 
study, the performance of the test must be compared to an FDA-cleared 
or approved comparator. The multisite method comparison study must 
include appropriate numbers and types of samples with analyte 
concentrations across the measuring range of the assay, representing 
clinically relevant genotypes. The multisite method comparison study 
design, including number of samples tested, must be sufficient to meet 
the following criteria:
    (1) Agreement between the two tests across the measuring range of 
the assays must have an r2 of greater than or equal to 0.95.
    (2) The bias between the test and comparator assay, as determined 
by difference plots, must be less than or equal to 0.5 log copies/mL.
    (vii) Detailed documentation of a single-site analytical method 
comparison study between the device and an FDA-cleared or approved 
comparator if a multisite clinical study is performed under 
paragraph(b)(2)(vi) of this section. The analytical method comparison 
study must use appropriate numbers and types of samples with analyte 
concentrations across the measuring range of the assay, representing 
clinically relevant genotypes. The results must meet the criteria in 
paragraphs (b)(2)(vi)(B)(1) and (2) of this section.
    (viii) Strategies for detection of new strains, types, subtypes, 
genotypes, and genetic mutations as they emerge.
    (ix) 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.
    (x) Final release criteria to be used for manufactured device lots 
with an appropriate justification that lots released at the extremes of 
the specifications will meet the claimed analytical and clinical 
performance

[[Page 66549]]

characteristics as well as the stability claims.
    (xi) All stability protocols, including acceptance criteria.
    (xii) Appropriate and acceptable procedure(s) for addressing 
complaints and other device information that determines when to submit 
a medical device report.
    (xiii) Premarket notification submissions must include the 
information contained in paragraphs (b)(2)(i) through (xii) of this 
section.

    Dated: October 28, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23868 Filed 11-3-22; 8:45 am]
BILLING CODE 4164-01-P