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Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests (Revised) Guidance for Test Developers and Food and Drug Administration Staff January 2023

Docket Number:
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

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 a policy and recommendations on evaluating the potential impact of emerging and future viral mutations of SARS-CoV-2 on COVID-19 tests. This guidance describes a policy for test developers to consider the impact of emerging and future variants on their COVID-19 tests during development and post-authorization. Throughout this guidance, references to COVID-19 tests are referring to molecular and antigen tests that detect the SARS-CoV-2 virus and serology tests that detect antibodies to the SARS-CoV-2 virus. 

This policy is 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.

Submit Comments

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:

Dockets Management
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.

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