FDA No Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators

If your email program has trouble displaying this email, view as a webpage.

FDA - Center for Devices and Radiological Health

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.