Proposed Device Reclassification HIV Tests

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES

tests and HIV nucleic acid (NAT)
diagnostic and supplemental tests,
postamendments class III devices with
the product code MZF, into class II
(special controls), subject to premarket
notification. FDA is also proposing new
device classification regulations along
with special controls that the Agency
believes are necessary to provide a
reasonable assurance of safety and
effectiveness for these devices. FDA is
proposing this reclassification on its
own initiative. If finalized, this order
will reclassify these types of devices
from class III (premarket approval) to
class II (special controls) and reduce the
regulatory burdens associated with
these devices, as these types of devices
will no longer be required to submit a
premarket approval application (PMA)
but can instead submit a premarket
notification (510(k)) and receive
clearance before marketing their device.
DATES: Submit either electronic or
written comments by April 21, 2020.
Please see section XI of this document
for the proposed effective date when the
new requirements apply and for the
proposed effective date of a final order
based on this proposed order.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before April 21,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of April 21, 2020. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.

Food and Drug Administration

Electronic Submissions

economic protection and therefore, FDA
would consider eliminating a food
standard if it is inconsistent with any of
these four principles.
i. Please explain whether you agree
with this framework.
ii. If you do not agree, what principles
should FDA consider when deciding
whether to eliminate a food standard?
b. The proposed rule explained that
FDA would consider revising or
establishing a new food standard only if
it was consistent with all 13 principles.
i. Please explain whether you agree
with this framework.
ii. If you do not agree, what principles
should FDA consider when deciding
whether to revise or establish a new
food standard?
5. What explanation is needed to
provide more clarity, certainty, or
context regarding:
a. The rationale for the principles?
b. How FDA will consider the
principles when evaluating whether to
eliminate, revise, or establish a new
food standard?
c. How stakeholders should use the
principles to inform the preparation of
petitions requesting that FDA eliminate,
revise, or establish a new food standard?
6. What additional information
should FDA consider when evaluating
the costs, benefits, and estimates of the
annual reporting burden of the proposed
rule?
Dated: February 13, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–03437 Filed 2–20–20; 8:45 am]
BILLING CODE 4164–01–P

21 CFR Part 866
[Docket No. FDA–2019–N–5192]

Microbiology Devices; Reclassification
of Human Immunodeficiency Virus
Serological Diagnostic and
Supplemental Tests and Human
Immunodeficiency Virus Nucleic Acid
Diagnostic and Supplemental Tests
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AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Proposed amendment; proposed

order.
SUMMARY: The Food and Drug
Administration (FDA or the Agency) is
proposing to reclassify certain human
immunodeficiency virus (HIV)
serological diagnostic and supplemental

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Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your

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comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed below (see ‘‘Written/
Paper Submissions’’ and
‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–N–5192 for ‘‘Microbiology
Devices; Reclassification of human
immunodeficiency virus serological
diagnostic and supplemental tests and
human immunodeficiency virus nucleic
acid diagnostic and supplemental tests’’.
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as

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‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Jenifer Roe, Center for Biologics
Evaluation and Review, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 7301, Silver Spring,
MD 20993–0002, 240–402–7911.
SUPPLEMENTARY INFORMATION:

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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), 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

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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

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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
safety and effectiveness of the device for
its intended use.
FDA relies upon ‘‘valid scientific
evidence,’’ as defined in section
513(a)(3) and 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). Publicly available
information excludes trade secret and/or
confidential commercial information,
e.g., the contents of a pending PMA (see
section 520(c) of the FD&C Act).
In accordance with section 513(f)(3) of
the FD&C Act, the Agency is issuing this
proposed order to reclassify HIV
serological diagnostic and supplemental
tests and HIV NAT diagnostic and
supplemental tests, postamendments
class III devices, into class II (special
controls), subject to premarket
notification because the Agency believes
the standard in section 513(a)(1)(B) of
the FD&C Act is met because there is
sufficient information to establish
special controls, in addition to general
controls, to provide reasonable
assurance of the safety and effectiveness
of the device.1
Section 510(m) of the FD&C Act
provides that a class II device may be
exempted from the premarket
notification requirements under section
510(k) of the FD&C Act if the Agency
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
reasonably assure the safety and
effectiveness of HIV serological
diagnostic and supplemental tests and
HIV NAT diagnostic and supplemental
tests. Therefore, the Agency does not
1 In December 2019, FDA began adding the term
‘‘Proposed amendment’’ to the ‘‘ACTION’’ caption
for these documents, typically styled ‘‘Proposed
order’’, to indicate that they ‘‘propose to amend’’
the Code of Federal Regulations. This editorial
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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intend to exempt this proposed class II
device from premarket notification
(510(k)) submission under section
510(m) of the FD&C Act.
II. Regulatory History of the Devices
This proposed order covers HIV
serological diagnostic and supplemental
tests and HIV NAT diagnostic and
supplemental tests. These are
prescription tests that are assigned
product code MZF. These
postamendments devices are currently
regulated as class III devices under
section 513(f)(1) of the FD&C Act. Based
on our review experience and consistent
with the FD&C Act and FDA’s
regulations in 21 CFR 860.134, FDA
believes that these devices should be
reclassified from class III into class II
with special controls because there is
sufficient information for these devices
to establish special controls that can
provide a reasonable assurance of the
device’s safety and effectiveness.
FDA has regulated the devices subject
to this proposed order for many years.
The first serological test intended for
use as an aid in the diagnosis of
infection with HIV was approved in
1987. The first supplemental test
intended for use as an aid in confirming
diagnosis of infection with HIV was
approved in 1992. Currently there are 11
diagnostic serological tests and 6
supplemental serological tests on the
market in the United States. In 2006,
FDA approved one NAT test that is
intended for use as an aid in the
diagnosis of infection with HIV. This
device is also approved as a
supplemental NAT test.
A review of the medical device
reporting databases indicates that there
is a low number of reported events for
HIV serological diagnostic and
supplemental tests and HIV NAT
diagnostic tests. Over 100 million HIV
tests subject to this proposed
reclassification have been sold since
2000, with less than 1,000 reported
events as of September 2019. Of these,
fewer than 40 are reported to involve
injuries due to false results; the
remainder are malfunctions, user errors,
or incorrect results that had no reported
effect on the individual being tested.
There have been less than 10 recalls
specific to these tests, and no class I
recalls, indicating a good safety record
for this device class.
III. Device Description
This proposed order applies to certain
HIV serological diagnostic and
supplemental tests that are prescription
devices for the qualitative detection of
HIV antigens and/or antibodies against
HIV in human body fluids or tissues. As

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such, the prescription device must
satisfy prescription labeling
requirements for in vitro diagnostic
products (see 21 CFR 809.10(a)(4) and
(b)(5)(ii)). The tests are intended for use
as an aid in the diagnosis of infection
with HIV. These devices are not
intended for monitoring patient status
or for screening donors of blood,
plasma, or human cells, tissues, or
cellular or tissue-based products (HCT/
Ps). HIV serological tests detect the
presence of HIV by using anti-HIV
antibodies and/or HIV antigens to detect
the presence of HIV antigens and/or
anti-HIV antibodies in human fluids.
The analytes are detected by chemical,
fluorescent, luminescent, or other
methods to produce a qualitative output
that determines the presence or absence
of HIV in the sample. Supplemental
serological tests are intended to be used
as an additional test to confirm the
presence of HIV antibodies or antigens
in specimens found to be repeatedly
reactive by a diagnostic screening
device. These tests are intended for
professional use only.
This proposed order also applies to
certain HIV NAT diagnostic and
supplemental tests that are prescription
devices for the detection of HIV nucleic
acid in human body fluids or tissues.
The tests are intended for use as an aid
in the diagnosis of infection with HIV.
These devices are not intended for
monitoring patient status, or for
screening donors of blood, plasma, or
HCT/Ps. HIV NAT tests detect the
presence of HIV by detecting HIV
nucleic acid in human body fluids or
from solutions after isolation of nucleic
acid from cells or tissues. The nucleic
acids are amplified and detected by
labeled probes that produce a
qualitative signal that indicates the
presence or absence of HIV nucleic acid
in the sample. Supplemental NAT tests
are intended to be used as an additional
test to confirm the presence of HIV
nucleic acid in specimens found to be
repeatedly reactive by a diagnostic
screening device. These tests are
intended for professional use only.
IV. Proposed Reclassification
FDA is proposing to reclassify HIV
serological diagnostic and supplemental
tests and HIV NAT diagnostic and
supplemental tests. FDA held a public
meeting on July 19, 2018, of the Blood
Products Advisory Committee,
convened as a medical device Panel
(‘‘the Panel’’), which unanimously
agreed that special controls, in addition
to general controls, are sufficient to
mitigate the risks to health from HIV
serological diagnostic and supplemental
tests and HIV NAT diagnostic and

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supplemental tests. The Panel believed
that class II with special controls would
provide reasonable assurance of the
safety and effectiveness of the device.
The Panel discussed the proposed
special controls (see section VII),
especially the performance criteria and
number of samples that would be
required for testing. The Panel also
recommended that FDA consider
reclassification from class III to class II
of HIV viral load tests indicated for use
for monitoring patient status.
The Agency believes that, at this time,
sufficient data and information exist
such that the risks to health identified
in section V can be mitigated by
establishing special controls that,
together with general controls, can
provide a reasonable assurance of the
safety and effectiveness of these devices.
Therefore, FDA proposes these devices
be reclassified from class III to class II.
In accordance with section 513(f)(3) of
the FD&C Act and 21 CFR part 860,
subpart C, FDA is proposing to
reclassify postamendments HIV
serological diagnostic and supplemental
tests and NAT diagnostic and
supplemental tests from class III into
class II. FDA believes that there are
sufficient data and information available
through FDA’s accumulated experience
with these devices from review
submissions, recommendations
provided by the Panel, and from
published literature to demonstrate that
the proposed special controls, along
with general controls, would effectively
mitigate the risks to health identified in
section V and provide a reasonable
assurance of safety and effectiveness of
these devices. Absent the special
controls identified in this proposed
order, general controls applicable to the
device are insufficient to provide
reasonable assurance of the safety and
effectiveness of the device. FDA expects
that the reclassification of these devices
would enable more manufacturers to
develop HIV serological diagnostic and
supplemental and NAT diagnostic and
supplemental tests such that patients
would benefit from increased access to
safe and effective tests.
FDA is proposing to create separate
classification regulations for HIV
serological diagnostic and supplemental
tests and HIV NAT diagnostic and
supplemental tests that will be
reclassified from class III to class II.
Under this proposed order, if finalized,
HIV serological diagnostic and
supplemental tests and HIV NAT
diagnostic and supplemental tests will
be identified as prescription devices. In
this proposed order the Agency has
proposed the special controls under
section 513(a)(1)(B) of the FD&C Act

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that, together with general controls,
would provide a reasonable assurance of
the safety and effectiveness of HIV
serological and NAT diagnostic and
supplemental tests.
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.
For these HIV serological diagnostic and
supplemental tests and HIV NAT
diagnostic and supplemental tests, FDA
has determined that premarket
notification is necessary to provide a
reasonable assurance of the safety and
effectiveness of the devices. Therefore,
FDA does not intend to exempt these
proposed class II devices from the
510(k) requirements. If this proposed
order is finalized, persons who intend to
market this type of device must submit
to FDA a 510(k) and receive clearance
prior to marketing the device.
This proposal, if finalized, will
decrease regulatory burden on industry,
as manufacturers will no longer have to
submit a PMA for these types of devices
but can instead submit a 510(k) to the
Agency for review prior to marketing
their device. A 510(k) is a less
burdensome pathway to market a
device, which typically results in a
shorter premarket review timeline
compared to a PMA. This ultimately
provides more timely access of these
types of devices to patients.
V. Risks to Health
HIV can be transmitted to others by
blood transfusion, sex, sharing of
contaminated needles by intravenous
drug users, and from mother to child
during pregnancy, childbirth, and breast
feeding (Ref. 1). Left untreated, a
significant proportion of those infected
with HIV will develop acquired
immunodeficiency syndrome (AIDS),
which causes significant morbidity and
mortality. However, with consistent
anti-retroviral treatment, HIV infection
is a treatable, chronic condition with
significantly improved survival and
quality of life for people living with HIV
and significantly decreased risk of
transmission to others (Ref. 2). The
Centers for Disease Control and
Prevention (CDC) recommends that all
persons ages 13 through 64 and
pregnant women be tested at least once,
with more frequent testing for
individuals at high risk of infection.
Nevertheless, at the present time, only
about 85 percent of people infected with
HIV in the United States know that they
are infected, and those who do not

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know their status are many times more
likely to transmit the virus to others
(Ref. 3). Therefore, improving access to
HIV diagnostic devices is an urgent
public health priority. After considering
the recommendations of the panel,
FDA’s accumulated experience with
these devices from review submissions,
and the published literature, FDA has
identified the following probable risks
to health associated with HIV
serological diagnostic and supplemental
tests:
(1) A false negative/false non-reactive
test result may influence patient
management decisions, such as the
withholding or discontinuation of
antiretroviral therapy, which can lead to
serious injury including death. A false
negative/false non-reactive test result
also may contribute to public health risk
by leading to inadvertent transmission
of virus by an infected person. Factors
that may cause decreased test sensitivity
and/or increased rate of false negative/
false non-reactive test reporting include,
but are not limited to, strain variability,
acquisition of de novo mutations in
genomic regions of HIV targeted by the
device, the presence of interfering
substances in the sample, acute
infection at a stage that is too early for
a device to detect the infection, and
analyte concentrations that are too low
to be detected by the device due to
suppression of analyte expression by
drugs used to treat or prevent HIV
infection. False negative/false nonreactive results also can be caused by
improper sample collection or sample
handling, loss of sensitivity of the
device, failure of detection reagents, and
failure of instruments. They also can be
caused by misinterpretation of invalid
results as negative.
(2) A false positive/false reactive test
result may contribute to unnecessary
initiation of treatment. It can also lead
to unnecessary interventions such as an
unnecessary Caesarian section for
women during childbirth, unnecessary
treatment of infants with anti-retroviral
medications, withholding of
breastfeeding, and significant emotional
stress. Factors that may lead to false
positive/false reactive results include
cross-reactivity with other substances in
the sample, contamination of the
sample, patient participation in vaccine
trials, and improper sample handling
and instrument use.
VI. Summary of the Reasons for
Reclassification
FDA believes that HIV serological
diagnostic and supplemental tests and
HIV NAT diagnostic and supplemental
tests should be reclassified from class III
(PMA) into class II (special controls)

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because special controls, in addition to
general controls, can be established to
mitigate the risks to health identified in
section V and provide reasonable
assurance of the safety and effectiveness
of these device types. The proposed
special controls are identified by FDA in
section VII. FDA’s reasons for
reclassification are as follows:
(1) There is substantial scientific and
medical information available regarding
the nature, complexity, and risks
associated with HIV serological
diagnostic and supplemental tests and
NAT diagnostic and supplemental tests.
The safety and effectiveness of this
device type has been well-established
by the performance of the more than 20
devices currently available (Ref. 4).
(2) Risks associated with the failure of
the device to perform as indicated (e.g.,
false negative/false non-reactive or false
positive/false reactive test results) can
be mitigated through a combination of
special controls, including performance
criteria and requirements for submission
of certain aspects of labeling,
submission of certain manufacturing
information, and submission of a
complaint log. Performance criteria will
consist primarily of analytical and
clinical study design specifications and
performance criteria that are based on
public information regarding the
performance and validation of
previously approved devices. Examples
of labeling mitigations include
appropriate limitations, including that
results should be confirmed according
to current guidelines as promulgated by
the CDC and other public health
authorities, which are necessary to
ensure that the devices are used and the
results are interpreted appropriately,
given the diversity of environments in
which they are intended to be used.
Manufacturing information submitted
will include summaries of strategies to
detect new types, subtypes, genotypes
and mutations to ensure the tests
continue to detect clinically relevant
forms of HIV, a summary of the design
matrix that determines the severity of
events to ensure appropriate adverse
event reporting, protocols for assessing
stability, evaluation of test performance
at the extremes of specifications to
ensure the tests have been validated to
function correctly under diverse
conditions. The complaint log that will
be submitted annually for 5 years
following clearance of a traditional
510(k) is the log required to be
maintained by device manufacturers
under 21 CFR 820.198(a). We are
proposing as a special control to require
submission of all complaints, whether
or not the complaint was reported under
part 803 (21 CFR part 803). We are not

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requiring submission of an annual
report as described in 21 CFR 814.84.
Review of the complaint log will allow
FDA to closely monitor issues with
manufacturing and implementation of
new devices that may not rise to the
level of adverse event reporting required
under 21 CFR 820.198(a) but that may
have an effect on the performance of the
devices.
Taking into account the probable
health benefits of the use of the device

and the nature and known incidence of
the risk of the device, FDA, on its own
initiative, is proposing to reclassify
these postamendments devices from
class III into class II. FDA believes that,
when used as indicated, HIV serological
and NAT diagnostic and supplemental
tests can provide significant benefits to
clinicians and patients.

VII. Proposed Special Controls
FDA believes that these devices can
be classified into class II with the
establishment of special controls. FDA
believes that these special controls, in
addition to general controls, will
provide a reasonable assurance of the
safety and efficacy of these devices.
Tables 1 and 2 demonstrate how these
proposed special controls will mitigate
each of the identified risks to health in
section V.

TABLE 1—RISKS TO HEALTH AND MITIGATION MEASURES FOR HIV SEROLOGICAL DIAGNOSTIC AND SUPPLEMENTAL TESTS
Identified risks to health

Mitigation measures

A false negative/false non-reactive test result may influence patient management decisions, such as the withholding of antiviral therapy, which can lead to serious
injury including death.

Labeling limitations, warnings, and interpretation requirements.
Analytical and clinical sensitivity performance criteria.
Clinical testing on appropriate populations.
Acceptable strategies for monitoring emergence of and ability of the test to detect
new or altered circulating forms of HIV.
Acceptable processes for failure mode analysis, testing performance at extremes of
specifications, determining severity of adverse events and malfunctions.
Submission of a complaint log to monitor decreases in test performance or manufacturing failures.
Labeling instructions for appropriate confirmation of results.
Analytical and clinical specificity performance criteria.
Clinical testing on appropriate populations.
Acceptable validation of susceptibility to interference and cross-reactivity.
Acceptable processes for failure mode analysis, testing performance at extremes of
specifications, determining severity of adverse events and malfunctions.
Submission of a complaint log to monitor trends in false positive results.

A false negative/false non-reactive test result may contribute to public health risk by leading to inadvertent
transmission of virus by an infected person.
A false positive/false reactive test result may contribute
to unnecessary initiation of treatment or other medical
interventions, which increases patient risk to the potential adverse effects of such treatments or medical interventions.

TABLE 2—RISKS TO HEALTH AND MITIGATION MEASURES FOR HIV NAT DIAGNOSTIC AND SUPPLEMENTAL TESTS
Identified risks to health

Mitigation measures

A false negative/false non-reactive test result may influence patient management decisions, such as the withholding of antiviral therapy, which can lead to serious
injury including death.
A false negative/false non-reactive test result may contribute to public health risk by leading to inadvertent
transmission of virus by an infected person.

khammond on DSKJM1Z7X2PROD with PROPOSALS

A false positive/false reactive result may contribute to unnecessary initiation of treatment or other medical intervention, which increases patient risk to the potential
adverse effects of such treatments or medical interventions.

If this proposed order is finalized,
HIV serological diagnostic and
supplemental tests and HIV NAT
diagnostic and supplemental tests will
be reclassified into class II (special
controls). As discussed below, the
reclassification will be codified in 21
CFR 866.3956 (serological) and 21 CFR
866.3957 (NAT) tests. Firms submitting
a 510(k) for an HIV serological
diagnostic and/or supplemental or HIV
NAT diagnostic and/or supplemental
test will be required to comply with the
particular mitigation measures set forth

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Labeling limitations, warnings, and interpretation requirements.
Analytical and clinical sensitivity performance criteria.
Clinical testing on appropriate populations.
Acceptable strategies for monitoring emergence of and ability of the test to detect
new or altered circulating forms of HIV.
Acceptable processes for failure mode analysis, testing performance at extremes of
specifications, determining severity of adverse events and malfunctions.
Submission of a complaint log to monitor decreases in test performance or manufacturing failures.
Labeling instructions for appropriate confirmation of results.
Analytical and clinical specificity performance criteria.
Clinical testing on appropriate populations.
Acceptable validation of susceptibility to interference and cross-reactivity.
Acceptable processes for failure mode analysis, testing performance at extremes of
specifications, determining severity of adverse events and malfunctions.
Submission of a complaint log to monitor trends in false positive results.

in the special controls. Adherence to the
special controls, in addition to the
general controls, is necessary to provide
a reasonable assurance of the safety and
effectiveness of the devices.
VIII. 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

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nor an environmental impact statement
is required.
IX. Paperwork Reduction Act of 1995
FDA tentatively concludes that this
proposed rule 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
proposed order refers to previously
approved FDA collections of
information. These collections of

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Federal Register / Vol. 85, No. 35 / Friday, February 21, 2020 / Proposed Rules
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; and
the collections of information in 21 CFR
parts 801 and 809 have been approved
under OMB control number 0910–0485.
X. 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. Therefore,
under section 513(f)(3), in the proposed
order, we are proposing to codify HIV
serological diagnostic and/or
supplemental tests in the new 21 CFR
866.3956, under which HIV serological
diagnostic and/or supplemental tests
would be reclassified from class III to
class II, and HIV NAT diagnostic and/
or supplemental tests in the new 21 CFR
866.3957, under which HIV NAT
diagnostic and/or supplemental tests
would be reclassified from class III to
class II.
XI. Proposed Effective Date
FDA proposes that any final order
based on this proposed order become
effective 30 days after its date of
publication in the Federal Register.

khammond on DSKJM1Z7X2PROD with PROPOSALS

XII. References
The following references have been
placed on display in the Dockets
Management Staff (see ADDRESSES) and
may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday; they are also 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. Branson, B.M., H.H. Handsfield, M.A.
Lampe, et al., ‘‘Revised Recommendations for
HIV Testing of Adults, Adolescents, and
Pregnant Women in Health-Care Settings,’’
MMWR. Recommendations and Reports:
Morbidity and Mortality Weekly Report,
55(RR14): 1–17, 2007.
2. Collaboration, T.A.T.C., ‘‘Survival of
HIV-Positive Patients Starting Antiretroviral
Therapy Between 1996 and 2013: A
Collaborative Analysis of Cohort Studies,’’
Lancet HIV, 2017.
3. Dailey, A.F., B.E. Hoots, H.I. Hall, et al.,
‘‘Vital Signs: Human Immunodeficiency
Virus Testing and Diagnosis Delays—United

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States,’’ MMWR. Recommendations and
Reports: Morbidity and Mortality Weekly
Report, 66: 1300–1306, 2017.
4. ‘‘Reclassification of HIV Point of Care
and Laboratory-Based Serological and NAT
Diagnostic Devices from Class III (PMA) to
Class II 510(k); Issue Summary; Prepared for
the July 19, 2018, Meeting of the Blood
Products Advisory Committee (BPAC)).’’
Available at: https://www.fda.gov/Advisory
Committees/CommitteesMeetingMaterials/
BloodVaccinesandOtherBiologics/Blood
ProductsAdvisoryCommittee/
ucm597841.htm.

10115

recommended actions to take based on
results.
(D) 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:
(1) The matrices with which the
device has been cleared, and that use of
this test kit with specimen types other
than those specifically cleared for this
device may result in inaccurate test
results.
List of Subjects in 21 CFR Part 866
(2) The test is not intended to be used
to monitor individuals who are
Biologics, Laboratories, Medical
undergoing treatment for HIV infection.
devices.
(3) A specimen with a reactive result
Therefore, under the Federal Food,
should be investigated further following
Drug, and Cosmetic Act and under
authority delegated to the Commissioner current guidelines.
(4) All test results should be
of Food and Drugs, it is proposed that
interpreted
in conjunction with the
21 CFR part 866 be amended as follows:
individual’s clinical presentation,
history, and other laboratory results.
PART 866—IMMUNOLOGY AND
(5) A test result that is nonreactive
MICROBIOLOGY DEVICES
does not exclude the possibility of
■ 1. The authority citation for part 866
exposure to or infection with HIV.
continues to read as follows:
Nonreactive results in this assay may be
due to analyte levels that are below the
Authority: 21 U.S.C. 351, 360, 360c, 360e,
limit of detection of this assay.
360j, 360l, 371.
(ii) Device verification and validation
■ 2. Add § 866.3956 to subpart D to read
must include:
as follows:
(A) Detailed device description,
§ 866.3956 Human immunodeficiency virus including the device components,
ancillary reagents required but not
(HIV) serological diagnostic and/or
provided, and an explanation of the
supplemental test.
methodology. Additional information
(a) Identification. Human
appropriate to the technology must be
immunodeficiency virus (HIV)
serological diagnostic and supplemental included such as the amino acid
sequence of antigen(s) and design of
tests are prescription devices for the
capture antibodies.
qualitative detection of HIV antigen(s)
(B) For devices with assay calibrators,
and/or detection of antibodies against
the design of all primary, secondary,
HIV in human body fluids or tissues.
and subsequent quantitation standards
The tests are intended for use as an aid
used for calibration as well as their
in the diagnosis of infection with HIV.
traceability to a reference material. In
The test results are intended to be
addition, analytical testing must be
interpreted in conjunction with other
performed following the release of a
relevant clinical and laboratory
new lot of the standard material that
findings. For professional use only.
was used for device clearance, or when
These tests are not intended to be used
there is a transition to a new calibration
for monitoring patient status, or for
standard.
screening donors of blood, plasma, or
(C) Detailed documentation of
human cells, tissues, and cellular and
analytical
performance studies
tissue-based products (HCT/Ps).
conducted as appropriate to the
(b) Classification. Class II (special
technology, specimen types tested, and
controls). The special controls for this
intended use of the device, including,
device are:
but not limited to, limit of blank, limit
(1) For all HIV serological diagnostic
of detection, cutoff determination,
and supplemental tests
precision, endogenous and exogenous
(i) The labeling must include:
interferences, cross reactivity, carry(A) An intended use that states that
over, quality control, matrix
the device is not intended for use for
equivalency, and sample and reagent
screening donors of blood, plasma, or
stability. Samples selected for use in
HCT/Ps.
analytical studies or used to prepare
(B) A detailed explanation of the
samples for use in analytical studies
principles of operation and procedures
must be from subjects with clinically
used for performing the assay.
relevant circulating genotypes in the
(C) A detailed explanation of the
United States.
interpretation of results and

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Federal Register / Vol. 85, No. 35 / Friday, February 21, 2020 / Proposed Rules

(D) Multisite reproducibility study
that includes the testing of three
independent production lots.
(E) Analytical sensitivity of the test
must be the same as or better than that
of other cleared or approved tests.
Samples tested must include
appropriate numbers and types of
samples, including real clinical samples
near the lower limit of detection.
Analytical specificity of the test must be
the same as or better than that of other
cleared or approved tests. Samples must
include appropriate numbers and types
of samples from patients with different
underlying illnesses or infections and
from patients with potential endogenous
interfering substances.
(F) Detailed documentation of
performance from a multisite clinical
study. Performance must be analyzed
relative to an FDA-cleared or approved
comparator. This study must be
conducted using patient samples, with
an appropriate number of HIV positive
and HIV negative samples in applicable
risk categories. Additional subgroups or
types must be validated using
appropriate numbers and types of
samples. The samples may be a
combination of fresh and repository
samples, sourced from within and
outside the United States, as
appropriate. The study designs,
including number of samples tested,
must be sufficient to meet the following
criteria:
(1) Clinical sensitivity of the test must
have a lower bound of the 95 percent
confidence interval of greater than or
equal to 99 percent.
(2) Clinical specificity of the test must
have a lower bound of the 95 percent
confidence interval of greater than or
equal to 99 percent.
(G) Strategies for detection of new
strains, types, subtypes, genotypes, and
genetic mutations as they emerge.
(H) 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.
(I) 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.
(J) All stability protocols, including
acceptance criteria.
(K) Proposed procedure(s) for
evaluating customer complaints and
other device information that
determines when to submit a medical
device report.
(L) Premarket notification
submissions must include the

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information contained in paragraph
(b)(1)(ii)(A) through (K) of this section.
(iii) Manufacturers must submit a log
of all complaints. The log must include
the following information regarding
each complaint: The type of event (false
negative/false non-reactive or false
positive/false reactive), lot, date,
population, and whether or not the
complaint was reported under part 803
of this chapter (Medical Device
Reporting). The log must be submitted
annually on the anniversary of
clearance, for 5 years following initial
clearance of a new traditional 510(k).
(2) If the test is intended for Point of
Care (PoC) use, the following special
controls, in addition to those listed in
paragraph (b)(1) of this section apply:
(i) The intended use must include a
statement that the test is for PoC use.
(ii) The PoC intended use must
include the following information:
(A) That distribution of the test is
limited to clinical laboratories that have
an adequate quality assurance program,
including planned systematic activities
that provide adequate confidence that
requirements for quality will be met and
where there is assurance that operators
will receive and use the instructional
materials.
(B) That the test is for use only by an
agent of a clinical laboratory.
(C) That individuals must receive the
‘‘Subject Information Notice’’ prior to
specimen collection and appropriate
information when test results are
provided.
(iii) PoC labeling must include
instructions to follow current guidelines
for informing the individual of the test
result and its interpretation.
(iv) The instructions must state that
reactive results are considered
preliminary and should be confirmed
following current guidelines.
(v) Device verification and validation
for the PoC claim must include:
(A) Detailed documentation of
performance from a multisite clinical
study. Performance must be analyzed
relative to an FDA cleared or approved
comparator. This study must be
conducted using patient samples, with
appropriate numbers of HIV positive
and HIV negative samples in applicable
risk categories. Additional subgroup or
type claims must be validated using
appropriate numbers and types of
samples. The samples may be a
combination of fresh and repository
samples, sourced from within and
outside the United States, as
appropriate. If the test is intended solely
for PoC use, the test must meet only the
performance criteria in paragraph
(b)(2)(v)(A)(1) and (2) of this section and

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not the criteria in paragraph (b)(1)(ii)(F)
of this section:
(1) Clinical sensitivity of the test must
have a lower bound of the 95 percent
confidence interval of greater than or
equal to 98 percent.
(2) Clinical specificity of the test must
have a lower bound of the 95 percent
confidence interval of greater than or
equal to 98 percent.
(B) Premarket notification
submissions must include the
information contained in paragraph
(b)(2)(v)(A) of this section.
(3) If the test is intended for
supplemental use in addition to use as
an aid in initial diagnosis, the following
special controls, in addition to those
listed in paragraphs (b)(1) and (2) of this
section, as appropriate, apply:
(i) For the additional supplemental
claim, a clinical study must be
performed that includes samples that
were initially reactive and repeatedly
reactive on a diagnostic test but were
negative or indeterminate on a different
confirmatory test.
(ii) The intended use must include a
statement that the test is intended for
use as an additional test to confirm the
presence of HIV antibodies or antigens
in specimens found to be repeatedly
reactive by a diagnostic screening test.
(4) If the test is intended solely as a
supplemental test, the following special
controls, in addition to those listed in
paragraphs (b)(1) and (2) of this section,
except those in paragraphs (b)(1)(ii)(F)
and (b)(2)(v)(A) of this section, as
appropriate, apply:
(i) The labeling must include a
statement that the test is intended for
use as an additional test to confirm the
presence of HIV antibodies or antigens
in specimens found to be repeatedly
reactive by a diagnostic screening test.
(ii) The labeling must clearly state
that the test is not for use for initial
diagnosis or is not intended as a firstline test.
(iii) A clinical study must be
performed that includes samples that
were initially reactive and repeatedly
reactive on a diagnostic test but were
negative or indeterminate on a
confirmatory test.
(5) If the test is intended to
differentiate different HIV types, the
following special controls, in addition
to those listed in paragraphs(b)(1)
through (4) of this section, as
appropriate, apply:
(i) The labeling must include the
statement that the test is intended for
the confirmation of initial results from
a diagnostic test and differentiation of
different HIV types.
(ii) Analytical and clinical sensitivity
and specificity for each of the HIV

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Federal Register / Vol. 85, No. 35 / Friday, February 21, 2020 / Proposed Rules
(5) A test result that is nonreactive
does not exclude the possibility of
exposure to or infection with HIV.
Nonreactive results in this assay may be
due to analyte levels that are below the
limit of detection of this assay.
(ii) Device verification and validation
must include:
(A) Detailed device description,
including the device components,
§ 866.3957 Human immunodeficiency virus ancillary reagents required but not
(HIV) nucleic acid (NAT) diagnostic and/or
provided, and an explanation of the
supplemental test.
methodology. Additional information
(a) Identification. Human
appropriate to the technology must be
immunodeficiency virus (HIV) nucleic
included such as design of primers and
acid (NAT) diagnostic and supplemental probes.
tests are prescription devices for the
(B) For devices with assay calibrators,
qualitative detection of HIV nucleic acid the design and nature of all primary,
in human body fluids or tissues. The
secondary, and subsequent quantitation
tests are intended for use as an aid in
standards used for calibration as well as
the diagnosis of infection with HIV. The their traceability to a reference material.
test results are intended to be
In addition, analytical testing must be
interpreted in conjunction with other
performed following the release of a
relevant clinical and laboratory
new lot of the standard material that
findings. For prescription use only.
was used for device clearance, or when
These tests are not intended to be used
there is a transition to a new calibration
for monitoring patient status, or for
standard.
(C) Detailed documentation of
screening donors of blood, plasma, or
analytical performance studies
human cells, tissues, or cellular or
conducted as appropriate to the
tissue-based products (HCT/Ps).
technology, specimen types tested, and
(b) Classification. Class II (special
intended use of the device, including,
controls). The special controls for this
but not limited to, limit of blank, limit
device are:
of detection, cutoff determination,
(1) For all HIV NAT diagnostic and/
precision, endogenous and exogenous
or supplemental tests
(i) The labeling must include:
interferences, cross reactivity, carry(A) An intended use that states that
over, quality control, matrix
the device is not intended for use for
equivalency, and sample and reagent
screening donors of blood, plasma, or
stability. Samples selected for use in
HCT/Ps.
analytical studies or used to prepare
(B) A detailed explanation of the
samples for use in analytical studies
principles of operation and procedures
must be from subjects with clinically
used for performing the assay.
relevant circulating genotypes in the
(C) A detailed explanation of the
United States. The effect of each
interpretation of results and
claimed nucleic-acid isolation and
recommended actions to take based on
purification procedure on detection
results.
must be evaluated.
(D) Limitations, which must be
(D) Multisite reproducibility study
updated to reflect current clinical
that includes the testing of three
practice and disease presentation and
independent production lots.
(E) Analytical sensitivity of the test
management. The limitations must
must be the same as or better than that
include, but are not limited to,
of other cleared or approved tests.
statements that indicate:
(1) The matrices with which the
Samples tested must include
device has been cleared, and that use of appropriate numbers and types of
this test kit with specimen types other
samples, including real clinical samples
than those specifically cleared for this
near the lower limit of detection.
device may result in inaccurate test
Analytical specificity of the test must be
results.
as the same as or better than that of
(2) The test is not intended to be used other cleared or approved tests. Samples
to monitor individuals who are
must include appropriate numbers and
undergoing treatment for HIV infection. types of samples from patients with
(3) A specimen with a reactive result
different underlying illnesses or
should be investigated further following infections and from patients with
current guidelines.
potential endogenous interfering
(4) All test results should be
substances.
(F) Detailed documentation of
interpreted in conjunction with the
performance from a multisite clinical
individual’s clinical presentation,
study. Performance must be analyzed
history, and other laboratory results.

khammond on DSKJM1Z7X2PROD with PROPOSALS

types, strains, and subtypes of HIV
intended to be differentiated must be
evaluated.
(iii) The results interpretation must
include instructions for the user on how
to interpret the results, including untypeable and co-infection results.
■ 3. Add § 866.3957 to subpart D to read
as follows:

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10117

relative to an FDA cleared or approved
comparator. This study must be
conducted using appropriate patient
samples, with appropriate numbers of
HIV positive and negative samples in
applicable risk categories. Additional
subtype, strain, or types must be
validated using appropriate numbers
and types of samples. The samples may
be a combination of fresh and repository
samples, sourced from within and
outside the United States, as
appropriate. The study designs,
including number of samples tested,
must be sufficient to meet the following
criteria:
(1) Clinical sensitivity of the test must
have a lower bound of the 95 percent
confidence interval of greater than or
equal to 99 percent.
(2) Clinical specificity of the test must
have a lower bound of the 95 percent
confidence interval of greater than or
equal to 99 percent.
(G) Strategies for detection of new
strains, types, subtypes, genotypes, and
genetic mutations as they emerge.
(H) 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.
(I) 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.
(J) All stability protocols, including
acceptance criteria.
(K) Proposed procedure(s) for
evaluating customer complaints and
other device information that determine
when to submit a medical device report.
(L) Premarket notification
submissions must include the
information contained in paragraph
(b)(1)(ii)(A) through (K) of this section.
(iii) Manufacturers must submit a log
of all complaints. The log must include
the following information regarding
each complaint: The type of event (false
negative/false non-reactive or false
positive/false reactive), lot, date,
population, and whether or not the
complaint was reported under part 803
of this chapter (Medical Device
Reporting). The log must be submitted
annually on the anniversary of
clearance, for 5 years following initial
clearance of a new traditional 510(k).
(2) If the test is intended for Point of
Care (PoC) use, the following special
controls, in addition to those listed in
paragraph (b)(1) of this section, apply:
(i) The intended use must include a
statement that the test is for PoC use.

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Federal Register / Vol. 85, No. 35 / Friday, February 21, 2020 / Proposed Rules

(ii) The PoC intended use must
include the following information:
(A) That distribution of the test is
limited to clinical laboratories that have
an adequate quality assurance program,
including planned systematic activities
that provide adequate confidence that
requirements for quality will be met and
where there is assurance that operators
will receive and use the instructional
materials.
(B) That the test is for use only by an
agent of a clinical laboratory.
(C) That individuals must receive the
‘‘Subject Information Notice’’ prior to
specimen collection and appropriate
information when test results are
provided.
(iii) PoC labeling must include
instructions to follow current guidelines
for informing the individual of the test
result and its interpretation.
(iv) The instructions must state that
reactive results are considered
preliminary and should be confirmed
following current guidelines.
(v) Device verification and validation
for the PoC claim must include:
(A) Detailed documentation from a
well-conducted multisite clinical study.
Performance must be analyzed relative
to an FDA cleared or approved
comparator. This study must be
conducted using patient samples, with
appropriate numbers of HIV positive
and HIV negative samples in applicable
risk categories. Additional subgroup or
type claims must be validated using
appropriate numbers and types of
samples. The samples may be a
combination of fresh and repository
samples, sourced from within and
outside the United States, as
appropriate. If the test is intended solely
for PoC use, the test must meet only the
performance criteria in paragraphs
(b)(2)(v)(A)(1) and (2) of this section and
not the criteria in paragraph (b)(2)(ii)(F)
of this section:
(1) Clinical sensitivity of the test must
have a lower bound of the 95 percent
confidence interval of greater than or
equal to 98 percent.
(2) Clinical specificity of the test must
have a lower bound of the 95 percent
confidence interval of greater than or
equal to 98 percent.
(B) Premarket notification
submissions must include the
information contained in paragraph
(b)(2)(v)(A) of this section.
(3) If the test is intended for
supplemental use in addition to use as
an aid in initial diagnosis, the following
special controls, in addition to those
listed in paragraphs (b)(1) and (2) of this
section, as appropriate, apply:
(i) For the additional supplemental
claim, a clinical study must be

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performed that includes samples that
were initially reactive and repeatedly
reactive on a diagnostic test but were
negative or indeterminate on a
confirmatory test.
(ii) The intended use must include a
statement that the test is intended for
use as an additional test to confirm the
presence of HIV viral nucleic acid in
specimens found to be repeatedly
reactive by a diagnostic screening test.
(4) If the test is intended solely as a
supplemental test, the following special
controls, in addition to those listed in
paragraphs (b)(1) and (2) of this section,
except those in paragraphs(b)(1)(ii)(F)
and (b)(2)(v)(A) of this section, as
appropriate, apply:
(i) The labeling must include a
statement that the test is intended for
use as an additional test to confirm the
presence of HIV viral nucleic acid in
specimens found to be repeatedly
reactive by a diagnostic screening test.
(ii) The labeling must clearly state
that the test is not for use for initial
diagnosis or is not intended as a firstline test.
(iii) A clinical study must be
performed that includes samples that
were initially reactive and repeatedly
reactive on a diagnostic test but were
negative or indeterminate on a
confirmatory test.
(5) If the test is intended to
differentiate different HIV types, the
following special controls, in addition
to those listed in paragraphs (b)(1)
through (4) of this section, as
appropriate, apply:
(i) The labeling must include the
statement that the test is intended for
the confirmation of initial results and
differentiation of different HIV types.
(ii) Analytical and clinical sensitivity
and specificity for each of the types,
strains, and subtypes of HIV intended to
be differentiated must be evaluated.
(iii) The results interpretation must
include instructions for the user on how
to interpret the results, including untypeable and co-infection results.
Dated: February 18, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–03515 Filed 2–20–20; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF VETERANS
AFFAIRS
38 CFR Parts 17 and 70
RIN 2900–AQ44

VHA Claims and Appeals
Modernization
AGENCY:

PO 00000

Department of Veterans Affairs.

Frm 00023

Fmt 4702

Sfmt 4702

ACTION:

Proposed rule.

SUMMARY: The Department of Veterans
Affairs (VA) proposes to amend its
regulations concerning its claims and
appeals process governing various
programs administrated by the Veterans
Health Administration (VHA). The
Veterans Appeals Improvement and
Modernization Act of 2017 (AMA)
amended the procedures applicable to
administrative review and appeal of VA
decisions on claims for benefits,
creating a new, modernized review
system. This rulemaking proposes
amendments to sunset certain VHA
regulations which are inconsistent with
AMA.
DATES: Comments must be received on
or before April 21, 2020.
FOR FURTHER INFORMATION CONTACT: Erik
Shepherd, Program Specialist, Office of
Regulatory and Administrative Affairs,
Department of Veterans Affairs, 810
Vermont Ave. NW, Washington, DC
20420, (202) 461–9596 (This is not a
toll-free number.).
ADDRESSES: Written comments may be
submitted through
www.Regulations.gov; by mail or handdelivery to Director, Office of Regulation
Policy and Management (00REG),
Department of Veterans Affairs, 810
Vermont Avenue NW, Room 1064,
Washington, DC 20420; or by fax to
(202) 273–9026. Comments should
indicate that they are submitted in
response to [RIN 2900–AQ44 VHA
Appeals Modernization.] Copies of
comments received will be available for
public inspection in the Office of
Regulation Policy and Management,
Room 1064, between the hours of 8:00
a.m. and 4:30 p.m., Monday through
Friday (except holidays). Please call
(202) 461–4902 for an appointment.
(This is not a toll-free number.) In
addition, during the comment period,
comments may be viewed online
through the Federal Docket Management
System (FDMS) at www.Regulations.gov.
SUPPLEMENTARY INFORMATION: Public
Law 115–55, the Veterans Appeals
Improvement and Modernization Act of
2017 (AMA), changes the processes by
which veterans seek review of VA
benefits decisions. VA has implemented
the AMA in a rulemaking that is
generally applicable to benefits
administered throughout VA, to include
benefits administered by the Veterans
Health Administration (VHA). VA
Claims and Appeals Modernization, 84
FR 138, 172 (Jan. 18, 2019). That
rulemaking specifically provides,
‘‘unless otherwise specified in this final
rule, VA amends its regulations
applicable to all claims processed under

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