Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect or Measure Nucleic Acid From Viruses Associated With Head and Neck Cancers, 75491-75493 [2024-20896]
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Federal Register / Vol. 89, No. 179 / Monday, September 16, 2024 / Rules and Regulations
75491
TABLE 1—CLOZAPINE TEST SYSTEM RISKS AND MITIGATION MEASURES—Continued
Identified risks to health
Mitigation measures
Incorrect interpretation of test results ................................
FDA has determined that special
controls, in combination with the
general controls, address these risks to
health and provide reasonable assurance
of safety and effectiveness. For a device
to fall within this classification, and
thus avoid automatic classification in
class III, it would have to comply with
the special controls named in this final
order. The necessary special controls
appear in the regulation codified by this
order. This device is subject to
premarket notification requirements
under section 510(k) of the FD&C Act.
lotter on DSK11XQN23PROD with RULES1
III. 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.
IV. Paperwork Reduction Act of 1995
This final order establishes special
controls that refer to previously
approved collections of information
found in other FDA regulations and
guidance. These collections of
information are subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3521). The
collections of information in part 860,
subpart D, regarding De Novo
classification have been approved under
OMB control number 0910–0844; the
collections of information in 21 CFR
part 814, subparts A through E,
regarding premarket approval, have
been approved under OMB control
number 0910–0231; 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, regarding quality system
regulation, have been approved under
OMB control number 0910–0073; and
the collections of information in 21 CFR
parts 801 and 809, regarding labeling,
have been approved under OMB control
number 0910–0485.
List of Subjects in 21 CFR Part 862
Medical devices.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
VerDate Sep<11>2014
16:12 Sep 13, 2024
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Certain design verification and validation activities and Certain labeling information.
of Food and Drugs, 21 CFR part 862 is
amended as follows:
PART 862—CLINICAL CHEMISTRY
AND CLINICAL TOXICOLOGY
DEVICES
1. The authority citation for part 862
continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Add § 862.3245 to subpart D to read
as follows:
conjunction with information available
from clinical evaluations and other
diagnostic procedures and that results
from the assay alone should not be used
in making treatment decisions.
Dated: September 10, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–20895 Filed 9–13–24; 8:45 am]
BILLING CODE 4164–01–P
■
§ 862.3245
Clozapine test system.
(a) Identification. A clozapine test
system is a device intended to measure
clozapine in human specimens.
Measurements obtained by this device
are used in monitoring levels of
clozapine to ensure appropriate therapy
in patients with treatment-resistant
schizophrenia.
(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) Design verification and validation
must include the following:
(i) Precision study data that
demonstrates precision that is clinically
appropriate, as determined by FDA, for
the clozapine test system. Precision
studies must include a minimum of
three samples containing different
concentrations of clozapine including
near medical decision points and
throughout the expected therapeutic
range of clozapine. Samples near the
medical decision points must be clinical
specimens collected from patients
taking clozapine;
(ii) Method comparison data that
demonstrates accuracy that is clinically
acceptable, as determined by FDA, for
the clozapine test system;
(iii) Data from studies that
demonstrate that the device is free from
clinically significant interference, as
determined by FDA, from commonly coadministered medications that are used
in patients with treatment-resistant
schizophrenia; and
(iv) Data from studies that
demonstrate that the device is free from
clinically significant cross-reactivity, as
determined by FDA, from major
circulating metabolites found in the
intended use population.
(2) The labeling required under
§ 809.10 of this chapter must include a
limiting statement conveying that the
assay should only be used in
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. FDA–2024–N–4061]
Medical Devices; Immunology and
Microbiology Devices; Classification of
the Device To Detect or Measure
Nucleic Acid From Viruses Associated
With Head and Neck Cancers
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final amendment; final order.
The Food and Drug
Administration (FDA, Agency, or we) is
classifying the device to detect or
measure nucleic acid from viruses
associated with head and neck cancers
into class II (special controls). The
special controls that apply to the device
type are identified in this order and will
be part of the codified language for the
device to detect or measure nucleic acid
from viruses associated with head and
neck cancers’ classification. We are
taking this action because we have
determined that classifying the device
into class II (special controls) will
provide a reasonable assurance of safety
and effectiveness of the device. We
believe this action will also enhance
patients’ access to beneficial innovative
devices.
DATES: This order is effective September
16, 2024. The classification was
applicable on May 11, 2020.
FOR FURTHER INFORMATION CONTACT: Kim
Davis, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3220, Silver Spring,
MD 20993–0002, 301–796–1049,
Kim.Davis@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
E:\FR\FM\16SER1.SGM
16SER1
75492
Federal Register / Vol. 89, No. 179 / Monday, September 16, 2024 / Rules and Regulations
I. Background
Upon request, FDA has classified the
device to detect or measure nucleic acid
from viruses associated with head and
neck cancers as class II (special
controls), which we have determined
will provide a reasonable assurance of
safety and effectiveness.
The automatic assignment of class III
occurs by operation of law and without
any action by FDA, regardless of the
level of risk posed by the new device.
Any device that was not in commercial
distribution before May 28, 1976, is
automatically classified as, and remains
within, class III and requires premarket
approval unless and until FDA takes an
action to classify or reclassify the device
(see 21 U.S.C. 360c(f)(1)). We refer to
these devices as ‘‘postamendments
devices’’ because they were not in
commercial distribution prior to the
date of enactment of the Medical Device
Amendments of 1976, which amended
the Federal Food, Drug, and Cosmetic
Act (FD&C Act).
FDA may take a variety of actions in
appropriate circumstances to classify or
reclassify a device into class I or II. We
may issue an order finding a new device
to be substantially equivalent under
section 513(i) of the FD&C Act (see 21
U.S.C. 360c(i)) to a predicate device that
does not require premarket approval.
We determine whether a new device is
substantially equivalent to a predicate
device by means of the procedures for
premarket notification under section
510(k) of the FD&C Act (21 U.S.C.
360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device
through ‘‘De Novo’’ classification, a
common name for the process
authorized under section 513(f)(2) of the
FD&C Act (see also part 860, subpart D
(21 CFR part 860, subpart D)). Section
207 of the Food and Drug
Administration Modernization Act of
1997 (Pub. L. 105–115) established the
first procedure for De Novo
classification. Section 607 of the Food
and Drug Administration Safety and
Innovation Act (Pub. L. 112–144)
modified the De Novo application
process by adding a second procedure.
A device sponsor may utilize either
procedure for De Novo classification.
Under the first procedure, the person
submits a 510(k) for a device that has
not previously been classified. After
receiving an order from FDA classifying
the device into class III under section
513(f)(1) of the FD&C Act, the person
then requests a classification under
section 513(f)(2).
Under the second procedure, rather
than first submitting a 510(k) and then
a request for classification, if the person
determines that there is no legally
marketed device upon which to base a
determination of substantial
equivalence, that person requests a
classification under section 513(f)(2) of
the FD&C Act.
Under either procedure for De Novo
classification, FDA is required to
classify the device by written order
within 120 days. The classification will
be according to the criteria under
section 513(a)(1) of the FD&C Act.
Although the device was automatically
placed within class III, the De Novo
classification is considered to be the
initial classification of the device.
When FDA classifies a device into
class I or II via the De Novo process, the
device can serve as a predicate for
future devices of that type, including for
510(k)s (see section 513(f)(2)(B)(i) of the
FD&C Act). As a result, other device
sponsors do not have to submit a De
Novo request or premarket approval
application to market a substantially
equivalent device (see section 513(i) of
the FD&C Act, defining ‘‘substantial
equivalence’’). Instead, sponsors can use
the 510(k) process, when necessary, to
market their device.
II. De Novo Classification
On June 24, 2019, FDA received
Advance Sentry Corp.’s request for De
Novo classification of the NP Screen.
FDA reviewed the request in order to
classify the device under the criteria for
classification set forth in section
513(a)(1) of the FD&C Act.
We classify devices into class II if
general controls by themselves are
insufficient to provide reasonable
assurance of safety and effectiveness,
but there is sufficient information to
establish special controls that, in
combination with the general controls,
provide reasonable assurance of the
safety and effectiveness of the device for
its intended use (see 21 U.S.C.
360c(a)(1)(B)). After review of the
information submitted in the request,
we determined that the device can be
classified into class II with the
establishment of special controls. FDA
has determined that these special
controls, in addition to the general
controls, will provide reasonable
assurance of the safety and effectiveness
of the device.
Therefore, on May 11, 2020, FDA
issued an order to the requester
classifying the device into class II. In
this final order, FDA is codifying the
classification of the device by adding 21
CFR 866.3236.1 We have named the
generic type of device as device to
detect or measure nucleic acid from
viruses associated with head and neck
cancers, and it is identified as an in
vitro diagnostic test for prescription use
in the detection of viral nucleic acid in
nasopharyngeal or oropharyngeal
cellular specimens from patients with
signs and symptoms of head and neck
cancer. The test result is intended to be
used in conjunction with other clinical
information to aid in assessing the
clinical status of virus-associated head
and neck cancers and/or the likelihood
that head and neck cancer is present.
FDA has identified the following risks
to health associated specifically with
this type of device and the measures
required to mitigate these risks in table
1.
TABLE 1—DEVICE TO DETECT OR MEASURE NUCLEIC ACID FROM VIRUSES ASSOCIATED WITH HEAD AND NECK CANCERS
RISKS AND MITIGATION MEASURES
Identified risks to health
Mitigation measures
False test results ................................................................
lotter on DSK11XQN23PROD with RULES1
Failure to correctly interpret the test results ......................
Use of certain specimen collection and transport devices; Certain labeling information; and Certain design verification and validation.
Certain labeling information.
FDA has determined that special
controls, in combination with the
general controls, address these risks to
health and provide reasonable assurance
of safety and effectiveness. For a device
to fall within this classification, and
1 FDA notes that the ACTION caption for this final
order is styled as ‘‘Final amendment; final order,’’
rather than ‘‘Final order.’’ Beginning in December
2019, this editorial change was made to indicate
that the document ‘‘amends’’ the Code of Federal
Regulations. The change was made in accordance
with the Office of Federal 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.
VerDate Sep<11>2014
16:12 Sep 13, 2024
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PO 00000
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Fmt 4700
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E:\FR\FM\16SER1.SGM
16SER1
Federal Register / Vol. 89, No. 179 / Monday, September 16, 2024 / Rules and Regulations
thus avoid automatic classification in
class III, it would have to comply with
the special controls named in this final
order. The necessary special controls
appear in the regulation codified by this
order. This device is subject to
premarket notification requirements
under section 510(k) of the FD&C Act.
III. 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.
IV. Paperwork Reduction Act of 1995
This final order establishes special
controls that refer to previously
approved collections of information
found in other FDA regulations and
guidance. These collections of
information are subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3521). The
collections of information in part 860,
subpart D, regarding De Novo
classification have been approved under
OMB control number 0910–0844; the
collections of information in 21 CFR
part 814, subparts A through E,
regarding premarket approval, have
been approved under OMB control
number 0910–0231; 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, regarding quality system
regulation, have been approved under
OMB control number 0910–0073; and
the collections of information in 21 CFR
parts 801 and 809, regarding labeling,
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:
lotter on DSK11XQN23PROD with RULES1
PART 866—IMMUNOLOGY AND
MICROBIOLOGY DEVICES
1. The authority citation for part 866
continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Add § 866.3236 to subpart D to read
as follows:
■
VerDate Sep<11>2014
16:12 Sep 13, 2024
Jkt 262001
§ 866.3236 Device to detect or measure
nucleic acid from viruses associated with
head and neck cancers.
(a) Identification. A device to detect
or measure nucleic acid from viruses
associated with head and neck cancers
is an in vitro diagnostic test for
prescription use in the detection of viral
nucleic acid in nasopharyngeal or
oropharyngeal cellular specimens from
patients with signs and symptoms of
head and neck cancer. The test result is
intended to be used in conjunction with
other clinical information to aid in
assessing the clinical status of virusassociated head and neck cancers and/
or the likelihood that head and neck
cancer is present.
(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) Any device used for specimen
collection and transport must be FDAcleared, -approved, or -classified as
510(k) exempt (standalone or as part of
a test system) for the collection of
human specimens; alternatively, the
sample collection device must be
cleared in a premarket submission as a
part of this device.
(2) The labeling required under
§ 809.10(b) of this chapter must include,
as determined to be appropriate by FDA:
(i) An intended use statement that
includes the following:
(A) The analyte(s) detected by the
device;
(B) Data output of the device
(qualitative, semiquantitative, or
quantitative);
(C) The specimen types with which
the device is intended for use;
(D) The clinical indications
appropriate for test use (e.g., in
conjunction with endoscopy);
(E) The intended use populations
(e.g., signs and symptoms, ethnicity);
and
(F) The intended use location(s) (e.g.,
specific name and location of testing
facility or facilities).
(ii) A detailed device description,
including reagents, instruments,
ancillary materials, specimen collection
and transport devices, controls, and a
detailed explanation of the
methodology, including all preanalytical methods for processing of
specimens.
(iii) A detailed explanation of the
interpretation of results.
(iv) Limiting statements indicating:
(A) The device is not intended for use
in screening for head and neck cancer
in asymptomatic populations.
(B) Results of the device are not
predictive of a patient’s future risk of
head and neck cancer.
(C) Patients who test negative for the
virus should be managed in accordance
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75493
with the standard of care, based on the
assessment of endoscopy and/or other
clinical information by a licensed
healthcare professional.
(D) Results of the device are not
intended to be used as the sole basis for
determining the need for biopsy or for
any other patient management decision.
(3) Design verification and validation
must include the following:
(i) A detailed device description
including pre-analytical specimen
processing, assay technology, target
region, primer/probe sequences,
reagents, controls, instrument
requirements, and the computational
path from collected raw data to reported
result.
(ii) Detailed documentation and
results from analytical performance
studies, including characterization of
the cutoff(s), limit of detection, limit of
quantitation, precision (including
multisite reproducibility, if applicable),
inclusivity, cross-reactivity,
interference, carryover/crosscontamination, reagent stability, and
specimen/sample stability, as
determined to be appropriate by FDA.
(iii) Detailed documentation of a
clinical performance study that includes
patients from the intended use
population, including the clinical study
protocol, with a predefined statistical
analysis plan, and a clinical study
report with testing results and results of
all statistical analyses.
(iv) A detailed description of the
impact of any software, including
software applications and software
incorporated in hardware-based devices,
on the device’s functions.
Dated: September 10, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–20896 Filed 9–13–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 876
[Docket No. FDA–2024–N–4082]
Medical Devices; Therapeutic Devices;
Classification of the Pediatric
Continuous Renal Replacement
Therapy System
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final amendment; final order.
The Food and Drug
Administration (FDA, Agency, or we) is
SUMMARY:
E:\FR\FM\16SER1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 179 (Monday, September 16, 2024)]
[Rules and Regulations]
[Pages 75491-75493]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-20896]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. FDA-2024-N-4061]
Medical Devices; Immunology and Microbiology Devices;
Classification of the Device To Detect or Measure Nucleic Acid From
Viruses Associated With Head and Neck Cancers
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
classifying the device to detect or measure nucleic acid from viruses
associated with head and neck cancers into class II (special controls).
The special controls that apply to the device type are identified in
this order and will be part of the codified language for the device to
detect or measure nucleic acid from viruses associated with head and
neck cancers' classification. We are taking this action because we have
determined that classifying the device into class II (special controls)
will provide a reasonable assurance of safety and effectiveness of the
device. We believe this action will also enhance patients' access to
beneficial innovative devices.
DATES: This order is effective September 16, 2024. The classification
was applicable on May 11, 2020.
FOR FURTHER INFORMATION CONTACT: Kim Davis, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3220, Silver Spring, MD 20993-0002, 301-796-1049,
[email protected].
SUPPLEMENTARY INFORMATION:
[[Page 75492]]
I. Background
Upon request, FDA has classified the device to detect or measure
nucleic acid from viruses associated with head and neck cancers as
class II (special controls), which we have determined will provide a
reasonable assurance of safety and effectiveness.
The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (see 21 U.S.C. 360c(i)) to a predicate device
that does not require premarket approval. We determine whether a new
device is substantially equivalent to a predicate device by means of
the procedures for premarket notification under section 510(k) of the
FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act (see also part 860, subpart D (21 CFR part 860, subpart D)).
Section 207 of the Food and Drug Administration Modernization Act of
1997 (Pub. L. 105-115) established the first procedure for De Novo
classification. Section 607 of the Food and Drug Administration Safety
and Innovation Act (Pub. L. 112-144) modified the De Novo application
process by adding a second procedure. A device sponsor may utilize
either procedure for De Novo classification.
Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
When FDA classifies a device into class I or II via the De Novo
process, the device can serve as a predicate for future devices of that
type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C
Act). As a result, other device sponsors do not have to submit a De
Novo request or premarket approval application to market a
substantially equivalent device (see section 513(i) of the FD&C Act,
defining ``substantial equivalence''). Instead, sponsors can use the
510(k) process, when necessary, to market their device.
II. De Novo Classification
On June 24, 2019, FDA received Advance Sentry Corp.'s request for
De Novo classification of the NP Screen. FDA reviewed the request in
order to classify the device under the criteria for classification set
forth in section 513(a)(1) of the FD&C Act.
We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
Therefore, on May 11, 2020, FDA issued an order to the requester
classifying the device into class II. In this final order, FDA is
codifying the classification of the device by adding 21 CFR
866.3236.\1\ We have named the generic type of device as device to
detect or measure nucleic acid from viruses associated with head and
neck cancers, and it is identified as an in vitro diagnostic test for
prescription use in the detection of viral nucleic acid in
nasopharyngeal or oropharyngeal cellular specimens from patients with
signs and symptoms of head and neck cancer. The test result is intended
to be used in conjunction with other clinical information to aid in
assessing the clinical status of virus-associated head and neck cancers
and/or the likelihood that head and neck cancer is present.
---------------------------------------------------------------------------
\1\ FDA notes that the ACTION caption for this final order is
styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal 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.
---------------------------------------------------------------------------
FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.
Table 1--Device To Detect or Measure Nucleic Acid From Viruses
Associated With Head and Neck Cancers Risks and Mitigation Measures
------------------------------------------------------------------------
Identified risks to health Mitigation measures
------------------------------------------------------------------------
False test results................ Use of certain specimen collection
and transport devices; Certain
labeling information; and Certain
design verification and validation.
Failure to correctly interpret the Certain labeling information.
test results.
------------------------------------------------------------------------
FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and
[[Page 75493]]
thus avoid automatic classification in class III, it would have to
comply with the special controls named in this final order. The
necessary special controls appear in the regulation codified by this
order. This device is subject to premarket notification requirements
under section 510(k) of the FD&C Act.
III. 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.
IV. Paperwork Reduction Act of 1995
This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections
of information in part 860, subpart D, regarding De Novo classification
have been approved under OMB control number 0910-0844; the collections
of information in 21 CFR part 814, subparts A through E, regarding
premarket approval, have been approved under OMB control number 0910-
0231; 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, regarding quality system regulation, have been approved under OMB
control number 0910-0073; and the collections of information in 21 CFR
parts 801 and 809, regarding labeling, 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. 866.3236 to subpart D to read as follows:
Sec. 866.3236 Device to detect or measure nucleic acid from viruses
associated with head and neck cancers.
(a) Identification. A device to detect or measure nucleic acid from
viruses associated with head and neck cancers is an in vitro diagnostic
test for prescription use in the detection of viral nucleic acid in
nasopharyngeal or oropharyngeal cellular specimens from patients with
signs and symptoms of head and neck cancer. The test result is intended
to be used in conjunction with other clinical information to aid in
assessing the clinical status of virus-associated head and neck cancers
and/or the likelihood that head and neck cancer is present.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Any device used for specimen collection and transport must be
FDA-cleared, -approved, or -classified as 510(k) exempt (standalone or
as part of a test system) for the collection of human specimens;
alternatively, the sample collection device must be cleared in a
premarket submission as a part of this device.
(2) The labeling required under Sec. 809.10(b) of this chapter
must include, as determined to be appropriate by FDA:
(i) An intended use statement that includes the following:
(A) The analyte(s) detected by the device;
(B) Data output of the device (qualitative, semiquantitative, or
quantitative);
(C) The specimen types with which the device is intended for use;
(D) The clinical indications appropriate for test use (e.g., in
conjunction with endoscopy);
(E) The intended use populations (e.g., signs and symptoms,
ethnicity); and
(F) The intended use location(s) (e.g., specific name and location
of testing facility or facilities).
(ii) A detailed device description, including reagents,
instruments, ancillary materials, specimen collection and transport
devices, controls, and a detailed explanation of the methodology,
including all pre-analytical methods for processing of specimens.
(iii) A detailed explanation of the interpretation of results.
(iv) Limiting statements indicating:
(A) The device is not intended for use in screening for head and
neck cancer in asymptomatic populations.
(B) Results of the device are not predictive of a patient's future
risk of head and neck cancer.
(C) Patients who test negative for the virus should be managed in
accordance with the standard of care, based on the assessment of
endoscopy and/or other clinical information by a licensed healthcare
professional.
(D) Results of the device are not intended to be used as the sole
basis for determining the need for biopsy or for any other patient
management decision.
(3) Design verification and validation must include the following:
(i) A detailed device description including pre-analytical specimen
processing, assay technology, target region, primer/probe sequences,
reagents, controls, instrument requirements, and the computational path
from collected raw data to reported result.
(ii) Detailed documentation and results from analytical performance
studies, including characterization of the cutoff(s), limit of
detection, limit of quantitation, precision (including multisite
reproducibility, if applicable), inclusivity, cross-reactivity,
interference, carryover/cross-contamination, reagent stability, and
specimen/sample stability, as determined to be appropriate by FDA.
(iii) Detailed documentation of a clinical performance study that
includes patients from the intended use population, including the
clinical study protocol, with a predefined statistical analysis plan,
and a clinical study report with testing results and results of all
statistical analyses.
(iv) A detailed description of the impact of any software,
including software applications and software incorporated in hardware-
based devices, on the device's functions.
Dated: September 10, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-20896 Filed 9-13-24; 8:45 am]
BILLING CODE 4164-01-P
