§ 866.3984 — Over-the-counter test to detect SARS-CoV-2 from clinical specimens.

§ 866.3984 Over-the-counter test to detect SARS-CoV-2 from clinical specimens.

(a) Identification. An over-the-counter test to detect SARS-CoV-2 from clinical specimens is an in vitro diagnostic device for the detection of SARS-CoV-2 in clinical specimens to aid in the diagnosis of SARS-CoV-2 infection. The device is intended to be used by lay users and without required health care provider intervention in home settings or similar environments in which lay users perform testing.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The intended use in the labeling required under § 809.10 of this chapter must include a description of the following: analytes the device detects and identifies, the specimen types tested, the results provided to the user, the clinical indications for which the test is to be used, the specific intended population(s), and other conditions of use as appropriate.

(2) The intended use of the device must only include indications for testing of respiratory specimens that are appropriate for collection by lay users for which there are performance data that demonstrate lay users can collect specimens without health care provider supervision in home settings or similar environments.

(3) The labeling required under § 809.10(b) of this chapter must include the following:

(i) A statement in the intended use that positive results do not rule out co-infection with other respiratory pathogens;

(ii) Summary instructions and information written in appropriate language for the intended user that includes easy to follow step-by-step instructions for sample testing, explanation of test results, any warnings and precautions relevant to testing, and frequently asked questions (FAQs), as required by paragraph (b)(5)(iii) of this section;

(iii) Limiting statements including the following, as applicable:

(A) For those devices intended for testing in symptomatic subjects, a specification of the number of days post symptom onset validated for use of the device and/or a range in which the performance of the test is known, where applicable;

(B) Statements that a negative test result does not preclude the possibility of infection with other pathogens, and that a positive test result does not preclude the possibility of co-infection with additional pathogens;

(C) A statement that persons with risk factors for severe disease from respiratory pathogens (e.g., chronic lung or heart disease, compromised immune system, diabetes, and other conditions listed by the Centers for Disease Control and Prevention (CDC)) should consult and follow-up with a healthcare provider, who will advise if additional testing or treatment are necessary;

(D) A statement that the test is not a substitute for consultation with a health care provider and should not be used to determine any treatments without provider supervision. A statement that the healthcare provider will consider additional information such as the patient's personal medical history and symptoms, current disease prevalence in the community, and additional test results if applicable, to help determine what steps are best for diagnosis and treatment if needed;

(E) A statement that it is especially important to discuss any test results with a healthcare provider if any of the following occur:

(1) The symptoms persist or worsen;

(2) The patient has high risk for severe illness based on age or medical condition;

(3) The patient has a condition that makes it difficult to use the test (e.g., problems with vision, handling the test components, or understanding test instructions or results); or

(4) The patient is performing this test on behalf of a person who has any of the above conditions;

(F) A statement that accurate results are dependent on adequate product storage and adherence to the specimen collection and testing procedures. A statement that failure to follow test procedures can lead to incorrect results;

(G) A statement that the test must not be used beyond the expiration date listed on the packaging. A statement that use of expired tests can lead to incorrect results;

(H) A statement that false positive test results are more likely when prevalence of SARS-CoV-2 is low in the community; and

(I) A statement that includes all of the following: The performance characteristics for SARS-CoV-2 were established when [insert predominant strain, subtype, or variant and timeframe] was dominant. Test accuracy may change as new SARS-CoV-2 viruses emerge. Additional testing with a lab-based molecular test (e.g., polymerase chain reaction (PCR)) should be considered in situations where a new virus or variant is suspected.

(4) The outer box label required under § 809.10(a) of this chapter must include the following:

(i) A description of who may use the test, including the presence of symptoms, the days post symptom onset and age restrictions (as applicable);

(ii) A list of the components included with the test;

(iii) A list of the components required to run the test, but not provided;

(iv) A statement that persons with risk factors for severe disease from respiratory pathogens should consult and follow-up with a healthcare provider.

(5) The device's labeling must include a prominent hyperlink to the manufacturer's public website where the manufacturer must make the information, identified in this section, publicly and prominently available. The information must include, written in language appropriate for the intended user:

(i) A brief summary of the purpose of the test;

(ii) Instructions that describe how to appropriately perform the test, interpret the results, and, if applicable, perform follow-up testing. The instructions must include the name and intended use of the test, detailed step-by-step instructions of the sample testing procedures, the result(s) interpretation guidance, warnings and limitation statements, information for troubleshooting, and technical assistance with the device (e.g., helpline contact information).

(iii) FAQ: This document must provide technical and educational information (e.g., what does this test do and not do, who should and should not use this test, and directions to resources for further information on the disease and epidemiology).

(iv) Information that demonstrates the performance characteristics established in the studies required under paragraph (b)(6) of this section.

(6) Design verification and validation must include:

(i) A detailed device description, including, but not limited to, device components, and a detailed explanation of the methodology, including viral target(s), identification of target detection reagents (e.g., primers, antibodies), internal controls, and computational path from collected raw data to reported result (e.g., how collected raw signals are converted into a reported signal and result), as applicable to the detection method and device design;

(ii) Detailed documentation of data from a prospective multisite clinical study with a design and performance that is appropriate for the intended use of the device, including performance estimates derived from a sufficient number of samples from the intended use population for each claimed specimen type. Results must be obtained from geographically diverse locations, such that the performance of the test device is appropriately representative of all present, circulating strains of the claimed viral analyte(s) at the time of the study and submission. Additionally, the clinical study must include participants that are representative of the intended use population and across the clinical range of the claimed viral analyte. The clinical study must be performed in the intended use setting (e.g., at home or a home-like environment). The results obtained with the candidate device must be compared to results obtained using a molecular comparator method that FDA has determined to be appropriate. Detailed documentation must include the clinical study protocol (including a predefined statistical analysis plan), study report, testing results, and results of all statistical analyses;

(iii) The clinical study designs, including number of samples tested, must be sufficient such that the lower bound of the two-sided 95 percent confidence interval of the positive percent agreement with the comparator must be greater than 70 percent and additional and appropriate risk mitigation measures are established (e.g., presumptive negative results, serial testing).

(iv) Detailed documentation of analytical studies, including those demonstrating the limit of detection, inclusivity (including relevant variants), cross-reactivity, microbial interference, interfering substances, competitive inhibition, specimen stability, within-lab precision, hook effect, carryover, and cross-contamination, as applicable;

(v) Detailed documentation and characterization (e.g., determination of the identity, supplier, purity, and stability) of all critical reagents and protocols for maintaining product integrity throughout its labeled shelf-life, i.e., reagent stability studies. Data and protocols, including acceptance criteria, from a multi-lot reagent stability study must include testing of samples with challenging analyte concentration and must include in-use or open-kit stability, shipping stability, and freeze-thaw stability (as applicable); and

(vi) Risk analysis and documentation demonstrating how risk control measures are implemented to address device system hazards, such as failure modes effects analysis and/or hazard analysis.

(A) This documentation must include a detailed description of a protocol (including all procedures and methods) for the continuous monitoring, identification, and handling of genetic mutations and/or novel isolates or strains (e.g., regular review of published literature and periodic in silico analysis of target sequences to detect possible mismatches). Protocols must include plans to update labeling with additional performance data. All results of this protocol, including any findings, must be documented and must include any additional data analysis that is requested by FDA in response to any performance concerns identified under this section or identified by FDA during routine evaluation. Additionally, if requested by FDA, these evaluations must be submitted to FDA for FDA review within 48 hours of the request and any results that are reasonably interpreted to support the conclusion that novel SARS-CoV-2 strains or isolates impact the stated expected performance of the device must be sent to FDA immediately to the email provided in FDA's request;

(B) This must include detailed documentation that demonstrates the effectiveness of risk control measures and device robustness, including the entire testing procedure from sampling to result interpretation, based on results from the following studies, as applicable per the intended use of the test device: usability studies, user label comprehension, and flex studies;

(vii) For devices with associated software or instrumentation, documentation must include a detailed description of device software, including software applications and hardware-based devices that incorporate software. The detailed description must include documentation of verification, validation, and hazard analysis and risk assessment activities, including an assessment of the impact of threats and vulnerabilities on device functionality and end users and patients as part of cybersecurity review; and

(viii) For devices intended for the detection of SARS-CoV-2 for which an FDA recommended reference material and/or test panel is available, the performance results of an analytical study testing the FDA recommended reference material. Detailed documentation must be kept of that study and its results, including the study protocol, study report for the proposed intended use, testing results, and results of all statistical analyses.

(7) If one of the actions listed in section 564(b)(1)(A) through (D) of the Federal Food, Drug, and Cosmetic Act occurs with respect to one or more of the analytes claimed in the intended use, or if the Secretary of Health and Human Services (HHS) determines, under section 319(a) of the Public Health Service Act, that a disease or disorder presents a public health emergency, or that a public health emergency otherwise exists, with respect to SARS-CoV-2:

(i) Within 30 days from the date that FDA notifies manufacturers that characterized samples are available for test evaluation, the manufacturer must have testing performed on the device with those samples in accordance with a standardized protocol considered and determined by FDA to be acceptable and appropriate; and

(ii) Within 60 days from the date that FDA notifies manufacturers that characterized samples are available for test evaluation and continuing until 3 years from that date, the results of the emergency analytical reactivity testing, including the detailed information for the samples tested as described in the certificate of authentication, must be included in a tabular format on the hyperlink the manufacturer's public website as described in paragraph (b)(5) of this section.

[91 FR 46717, July 24, 2026]