Protective Barrier Enclosures, Infusion Pump EUAs Revoked

Federal Register notice: FDA is announcing the revocations of Emergency Use Authorizations (EUAs) issued to manufacturers of certain protective barrier enclosures and to manufacturers of certain infusion pumps and accessories. FDA revoked the protective barrier enclosures EUA on 8/20 after becoming aware of new preliminary evidence from simulated intubation procedure models of potential adverse events that could occur or complications with protective barrier enclosures without negative pressure recently reported in the literature. The infusion pump EUA was revoked 9/21 based on information and experience since issuance of the umbrella EUA, Instead of an umbrella EUA, FDA may issue individual authorizations for infusion pumps and infusion pump accessories that meet the requisite EUA statutory criteria. To view the notice, click here.