(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 § 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.

[89 FR 75493, Sept. 16, 2024]