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Guidance Issuing OfficeCenter for Devices and Radiological Health
This is the seventh edition of this guidance, which originally issued February 29, 2020, and was subsequently revised on March 16, May 4, May 11, 2020, November 15, 2021, and September 27, 2022.
FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.
FDA is issuing this guidance to provide FDA’s review priorities and enforcement policies regarding novel coronavirus (COVID-19) tests. Rapid detection of COVID-19 cases in the United States requires wide availability of testing to control the spread of this highly contagious infection.
The policies in this guidance are intended to remain in effect only for the duration of the declaration under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by the Secretary of Health and Human Services (HHS) on February 4, 2020, declaring that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the novel coronavirus (2019-nCoV). FDA continues to assess the evolving situation and intends to update this guidance as appropriate.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2020-D-0987.