FDA Revokes Respirator, Decontamination Equipment Emergency Use Authorizations


By: Fran Kritz

July 28, 2021

Categories: AAMI News, Medical Device Manufacturers

Citing sufficient U.S. supply, the FDA recently revoked emergency use authorizations (EUAs) for disposable respirators not approved by National Institute of Occupational Safety and Health (NIOSH), as well as some decontamination equipment.

“Early in the public health emergency, there was a need to issue emergency use authorizations (EUAs) for non-NIOSH-approved respirators as well as decontamination and bioburden reduction systems to disinfect disposable respirators,” said Suzanne Schwartz, director of the Office of Strategic Partnerships and Technology Innovation in the FDA’s Center for Devices and Radiological Health, in a statement. “Today, those conditions no longer exist,” added Schwartz. “Our national supply of NIOSH-approved N95s is more accessible to our health care workers every day.”

According to the FDA, these actions are consistent with the Centers for Disease Control and Prevention’s (CDC's) updated recommendations that healthcare facilities return to conventional practices.

The decision, according to the FDA, is also consistent with the Occupational Safety and Health Administration’s (OSHA's) recently published guidance, which requires healthcare employers to provide NIOSH-approved or FDA-authorized respirators for workers who could potentially be exposed to COVID-19. According to the FDA, as of June 30, there were more than 6,400 total respirator models or configurations on the NIOSH-certified equipment list that have met the NIOSH-approved EUA criteria and are therefore FDA authorized.

Because of the increased availability of approved and authorized respirators, the FDA is also recommending that healthcare workers stop extended use of disposable respirators and instead use single use equipment for each patient.