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The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the recent monkeypox outbreak.
On August 9, 2022, the Secretary of the Department of Health and Human Services (HHS) determined1 under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that there is a public health emergency, or significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad that involves monkeypox virus. On September 7, 2022, the Secretary declared2 that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of monkeypox virus. Rapid detection of monkeypox cases in the United States requires wide availability of diagnostic testing to help control the spread of this contagious infection.
This guidance describes FDA’s review priorities of emergency use authorization (EUA) requests for monkeypox diagnostic tests, describes FDA’s enforcement policies for certain diagnostic tests that are developed by and performed in a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) that meets the requirements to perform tests of high complexity,3 provides recommendations for diagnostic test validation, describes FDA’s enforcement policies for FDA-cleared or authorized monkeypox diagnostic tests that are modified, and describes FDA’s enforcement policies for certain serology tests.
In light of the public health emergency, this guidance is being implemented without prior public comment because the FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C)(i) of the FD&C Act and 21 CFR 10.115(g)(2)). This guidance document is being issued without prior public comment, but it remains subject to comment in accordance with the Agency’s good guidance practices.
1 See HHS Secretary Section 564 Determination (Aug. 9, 2022)
2 See HHS Secretary Section 564 Determination (Sept. 7, 2022)
3 In this guidance, references to “high-complexity CLIA-certified laboratories” and “laboratories” are referring to single site laboratories that are certified under CLIA that meet the requirements to perform tests of high-complexity.
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-2022-D-1908.
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