NEW: FDA Revokes Emergency Use Authorizations (EUAs) on Certain Imported Face Masks
On June 30, 2021, the U.S. Food and Drug Administration (FDA) announced it is revoking the Emergency Use Authorizations (EUAs) for non-NIOSH-approved disposable respirators (revocations effective July 6, 2021) and the EUAs for decontamination and bioburden reduction systems (revocations effective June 30, 2021). As of the effective date of the revocations, these devices will no longer be authorized for emergency use by health care personnel in health care settings.
Non-NIOSH Filtering Facepiece Respirators (FFRs)
On April 3, 2020, the FDA issued an umbrella EUA for certain filtering facepiece respirators (FFRs) that are manufactured in China and are not approved by the National Institute for Occupational Safety and Health (NIOSH). The instructions below apply to non-NIOSH FFRs that were authorized for emergency use pursuant to an Emergency Use Authorization (EUA).
Based on the increased domestic supply of FFRs approved by the Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH) and in alignment with the Occupational Safety and Health Administration’s (OSHA) recently published Emergency Temporary Standard (ETS) for health care workers, the FDA believes health care facilities should not use crisis capacity strategies any longer which were recommended to address FFR shortages earlier during the COVID-19 outbreak.
Non-NIOSH FFRs are no longer authorized for use by health care personnel in a health care setting. Any non-NIOSH FFRs offered for import may not be sold or offered for sale to healthcare personnel for use in health care settings (refer to FAQs on the EUAs for Non-NIOSH Approved Respirators During the COVID-19 Pandemic). Importers may submit an application to FDA requesting permission to re-label or recondition such products using the Form FDA-766.
While it is possible that non-NIOSH-approved respirators may be reconditioned as face masks for use as source control (see reconditioning instructions in Import Alert 89-18), FDA does not recommend that non-NIOSH-approved respirators undergo reconditioning at this time because there is currently sufficient supply of source control devices.
Decontamination and Bioburden Reduction Systems
The instructions below apply to decontamination and bioburden reduction systems that were authorized for emergency use pursuant to an Emergency Use Authorization (EUA). Refer to the EUA Revocation letters for decontamination systems for more information. In addition, the Enforcement Policy for Bioburden Reduction Systems Using Dry Heat to Support Single-User Reuse of Certain Filtering Facepiece Respirators During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency has been withdrawn and no longer represents FDA’s current thinking. Based on increased domestic supply of new respirators, there is no longer a need to re-use FFRs that are labeled as single use medical devices.
As of 06/30/2021, decontamination and bioburden reduction systems are no longer authorized for emergency use and these systems should no longer be used to decontaminate or bioburden reduce disposable FFRs.
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