[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