Monkeypox emergency use authorizations for medical devices

Sept. 9, 2022
Monkeypox EUA update.

On August 9, 2022, the Secretary of the Department of Health and Human Services (HHS) determined, pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act, that there is a public health emergency, or a 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 the basis of this determination, on September 7, 2022, the Secretary of HHS has subsequently declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for SARS-CoV-2 detect and/or diagnose infection with non-variola Orthopoxvirus, pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.

FDA release

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