FDA Officially Revokes EUAs for COVID-Related Respirators, Decontamination Systems
FDA formally announced the revocation of emergency use authorizations for personal protective equipment and related products, as well as a COVID-19 test, in two notices released Aug. 30. Effective July 6, the FDA revoked its EUA for imported non-NIOSH approved…
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filtering facepiece respirators manufactured in China, as well as for manufacturers and other stakeholders of imported non-NIOSH approved filtering facepiece respirators, FDA said. Effective June 30, FDA revoked 12 authorizations for decontamination systems for personal protective equipment and one authorization for a bioburden reduction system for personal protective equipment, it said. Finally, FDA also revoked its EUA for a Curative COVID diagnostic device, effective July 15, the agency said.