Healthcare, Medical Devices, Regulatory Affairs

US FDA issue an EUA over imported Non-NIOSH Approved respirators

Food and Drug Administration, FDA, building Graphics Project

US FDA has reissued one of its Emergency Use Authorizations (EUAs) covering imported respirators that have not been approved by the National Institute for Occupational Safety and Health (NIOSH). The “Umbrella EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs)” continues to be valid, but the FDA is now restricting its use to previously authorized respirators.

The FDA continues to be vigilant and take prompt action on imported, non-NIOSH approved respirators to ensure healthcare personnel (HCP) receive adequate protection. On March 24, 2021, the FDA revised this EUA to authorize for emergency use only those respirators listed in the EUA’s Exhibit 1 as of the date of this reissuance. The FDA will no longer be reviewing requests and adding new respirator models to Exhibit 1 of this EUA.

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