FDA Revokes EUA for Non-NIOSH-Approved & Decontaminated Disposable Respirators
As of July 6, 2021, the FDA no longer approves the use of non-NIOSH-approved disposable respirators by healthcare personnel in healthcare settings. Additionally, the EUA for decontamination and bioburden reductions systems has been revoked as of June 30, 2021. This decision aligns with the CDC update advising that healthcare facilities should no longer be using crisis capacity strategies at this time and should return to conventional practices. The decision also aligns with the recent document from OSHA which provides emergency standards for occupational exposure to COVID-19.