Business · 31/08/2021

FDA Revokes 15 Emergency Use Authorizations for COVID-19 Medical Devices

The US Food and Drug Administration (FDA) has revoked 15 Emergency Use Authorizations (EUAs) for COVID-19 medical devices, including decontamination systems for personal protective equipment and certain imported respirators, due to non-compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocations took effect on June 30, 2021.