FDA releases transition plans for medical device enforcement, authorization after COVID-19 public health emergency

The Food and Drug Administration today released final guidance for transitioning medical device enforcement policies and emergency use authorizations established during the COVID-19 public health emergency to normal operations. The Biden Administration plans to end the COVID-19 PHE declaration on May 11. The COVID-19 EUA declaration for COVID-19 diagnostics, personal protective equipment, other medical devices, and drug and biological products will remain in effect until there is no longer a “significant potential” for a COVID-19 PHE or the authorized devices or products have been approved.