Termination of Three Declarations Authorizing Emergency Use of Medical Devices During the COVID-19 Pandemic

摘要

The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C) Act. On February 4, 2020, as amended on March 15, 2023, HHS determined 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 U.S. citizens living abroad, and that involves the virus (later referred to as SARS-CoV-2) that causes COVID-19. On the basis of this determination, the HHS Secretary declared that circumstances exist justifying the authorization of emergency use of (1) in vitro diagnostics for detection and/or diagnosis of SARS-CoV-2 (February 4, 2020); (2) personal respiratory protective devices during the COVID-19 outbreak (March 2, 2020); and (3) medical devices, including alternative products used as medical devices (March 24, 2020). On June 29, 2026, the HHS Secretary determined that circumstances no longer exist justifying the authorization of emergency use of these medical devices. On the basis of this determination, the HHS Secretary is terminating these declarations ("EUA decla