JD Supra

Be Prepared: FDA Signals Transition Countdown for Medical Devices Marketed Under COVID-Era Enforcement Policies, EUAs

On October 17, 2022, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released the list of guidance documents proposed for publication in fiscal year ...
MD&M East

Practical Considerations for Draft Transition Plans for Devices Under EUAs or COVID Enforcement Policies

On Jan. 31, 2020, the Department of Health and Human Services (HHS) declared a public health emergency (PHE) related to the global COVID-19 pandemic. The declaration of a PHE enabled FDA to issue a ...
JD Supra

The FDA Finalizes Transition Plan for Medical Device Authorizations and Policies Affected by Covid-19 PHE

The Food and Drug Administration (FDA) has announced transition plans for Emergency Use Authorization (EUA)-authorized medical devices and devices marketed pursuant to COVID-19-related guidance ...