Revocation of Authorizations of Emergency Use of Certain Medical Devices During COVID-19; Availability

概要

The Food and Drug Administration (FDA) is announcing the revocations of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Manufacturers of Protective Barrier Enclosures and Other Stakeholders for certain protective barrier enclosures ("PBE Authorization") and to Manufacturers of Infusion Pumps and Infusion Pump Accessories and Other Stakeholders for certain infusion pumps and infusion pump accessories ("Infusion Pump Authorization"). FDA revoked the PBE Authorization on August 20, 2020, and the Infusion Pump Authorization on September 21, 2020, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocations, which include an explanation of the reasons for each revocation, are reprinted in this document.