Rule2024-20896
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect or Measure Nucleic Acid From Viruses Associated With Head and Neck Cancers
Primary source
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Published
September 16, 2024
Effective
September 16, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 179 (Monday, September 16, 2024)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-20896]
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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.
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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,
<a href="/cdn-cgi/l/email-protection#22694b4f0c6643544b51624446430c4a4a510c454d54"><span class="__cf_email__" data-cfemail="367d5f5b187257405f4576505257185e5e4518515940">[email protected]</span></a>.
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.
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\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.
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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
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Identified risks to health Mitigation measures
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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.
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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
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