The FDA revoked the EUAs for non-NIOSH-approved disposable respirators and the EUAs for decontamination and bioburden reduction systems.

If your email program has trouble displaying this email, view as a webpage. FDA No Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators Today, the U.S. Food and Drug Administration (FDA) issued an updated Letter to Health Care Personnel and Facilities: FDA No Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators. The FDA is revoking the Emergency Use Authorizations (EUAs) for non-NIOSH-approved disposable respirators (revocation effective July 6, 2021) and the EUAs for decontamination and bioburden reduction systems (revocation effective June 30, 2021). As of the effective date of the revocations, these devices will no longer be authorized for use by health care personnel in health care settings. These actions are in follow-up to the May 27, 2021, letter in which the FDA recommended a transition away from non-NIOSH-approved disposable respirators as well as from reusing decontaminated or bioburden-reduced disposable respirators. Read More The Letter to Health Care Personnel and Facilities includes important information about the supply of NIOSH-approved respirators, including: Information on the domestic supply of NIOSH-approved respirators Recommendations for health care personnel Actions the FDA has taken Updates on related information from government partners such as CDC/NIOSH and OSHA Instructions for reporting problems with a device to the FDA Questions? If you have questions about respirators or decontamination systems, contact the Division of Industry and Consumer Education.

Follow us on Twitter at @FDADeviceInfo Manage Subscriptions  |  Unsubscribe All  |  Help

This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA