Food and Drug Administration (FDA) Revoking Emergency Use Authorizations (EAUs): Non-NIOSH Respirators, Decontamination/Bioburden Reduction Systems

CSMS #48653470 - Food and Drug Administration (FDA) Revoking Emergency Use Authorizations (EAUs): Non-NIOSH Respirators, Decontamination/Bioburden Reduction Systems U.S. Customs and Border Protection sent this bulletin at 07/01/2021 09:23 AM EDT CSMS #48653470 - Food and Drug Administration (FDA) Revoking Emergency Use Authorizations (EAUs): Non-NIOSH Respirators, Decontamination/Bioburden Reduction Systems FDA Revokes Emergency Use Authorizations for Non-NIOSH-Approved Disposable Respirators and Decontamination Systems as Access to FDA-authorized and NIOSH-approved N95s Increases Nationwide On 06/30/2021, 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) The instructions below apply to non-NIOSH FFRs that were authorized for emergency use pursuant to an Emergency Use Authorization (EUA) . Refer to the Letter to Health Care Personnel and Facilities and the Revocation letters for Non-NIOSH Approved Filtering Facepiece Respirators Manufactured in China and Imported, Non-NIOSH Approved Filtering Facepiece Respirators for more information. 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. Effective 07/06/2021, non-NIOSH FFRs will no longer be authorized for use by health care personnel in a health care setting.  Any non-NIOSH FFRs offered for import on or after the revocation date 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, among other things. 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. Coronavirus Disease 2019 (COVID-19), FAQs on the EUAs for Non-NIOSH Approved Respirators During the COVID-19 Pandemic , and COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders contain current information. For questions about the revocations, contact the Division of Industry and Consumer Education (DICE) . For inquiries related to importing COVID-19 supplies and medical products, contact COVID19FDAImportInquiries@fda.hhs.gov . For general import inquiries, contact FDAImportsInquiry@fda.hhs.gov .