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Emergency Use Respirator Authorizations No Longer in Effect

Posted: July 15, 2021

The U.S. Food and Drug Administration (FDA) no longer authorizes use of non-NIOSH-approved or decontaminated disposable respirators in health care settings.

The FDA announced the revocation of Emergency Use Authorizations (EUAs) on June 30 for imported, non-NIOSH-approved respirators as well as decontamination and bioburden reduction systems. This impacts all health care personnel, including emergency medical services personnel. The revocation of these EUAs was due to the increase in domestically manufactured, NIOSH-approved N95s available throughout the country.

On April 9, the FDA issued a letter to health care personnel and facilities, recommending a transition away from crisis capacity conservation strategies, such as decontaminating disposable respirators for reuse.

Early in the public health emergency, there was a need to issue EUAs for non-NIOSH-approved respirators as well as decontamination and bioburden reduction systems to disinfect disposable respirators. Those conditions no longer exist.

Since the beginning of the pandemic, NIOSH has approved more than 875 respirator models or configurations, with some of these manufactured by approximately 20 new, domestic NIOSH-approval holders. There are now more than 6,400 total respirator models or configurations on the NIOSH-certified equipment list.

The FDA recommends that health care agencies consider redistributing current inventory of non-NIOSH-approved respirators to non-health care settings for non-medical use (for example, construction), and to other countries in need.

The FDA also recommends agencies increase inventory of available NIOSH-approved respirators, including:

  • N95s and other disposable filtering facepiece respirators.
  • Elastomeric respirators, including new elastomeric respirators without an exhalation valve that can be used in an operating room.
  • Powered air-purifying respirators.

If you have questions about respirators or decontamination systems, you can contact FDA's Division of Industry and Consumer Education, which develops educational resources to help the medical device industry understand FDA regulations and policies.

This article is based on content in the
July 15, 2021 InfoGram.

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