The Biden administration announced on January 30, 2023, that it plans to terminate the COVID-19 public health emergency declaration (the “PHE declaration”) on May 11, 2023.
COVID-19 EUA medical products and policies
As FDA has clarified in its draft transition guidance for medical devices, the Emergency Use Authorizations (EUAs) of COVID-19 medical products may remain in effect regardless of the PHE declaration status. FDA’s EUA authority is based on the emergency use declaration under section 564 of the Federal Food, Drug, and Cosmetic Act (the “EUA declaration”), whereas the PHE declaration is under section 319 of the Public Health Service Act. Currently, there are active COVID-19 EUA declarations including those for in vitro diagnostics (IVDs), medical devices, and drugs and biological products. These EUA declarations could remain active for many years without the PHE declaration, to support existing COVID-19 EUAs and subject to FDA’s policy, new EUAs.
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