July 1, 2021

FDA revokes EUA for non-NIOSH-approved respirators

Editor's Note

The Food and Drug Administration (FDA) on June 30 announced that it is revoking the Emergency Use Authorizations (EUAs) for non-NIOSH-approved disposable respirators (including N95s), effective July 6. The announcement also revokes EUAs for decontamination and bioburden reduction systems for disposable respirators, effective immediately.

The FDA says the US is now better positioned to provide healthcare workers with access to NIOSH-approved N95s rather than use non-NIOSH-approved respirators or reusing decontaminated disposable respirators.

The FDA recommends healthcare workers transition from extended use of disposable respirators to single-use for single-patient interactions as appropriate.

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