Jul 3, 2021

FDA No Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators - Letter to Health Care Personnel and Facilities

The U.S. Food and Drug Administration (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.

Based on the increased domestic supply of respirators approved by the Centers for Disease Control and Prevention's (CDC) National Institute for Occupational Safety and Health (NIOSH), and consistent with CDC's updated recommendations and in alignment with the Occupational Safety and Health Administration's (OSHA) recently published Emergency Temporary Standard (ETS) to protect health care workers, the FDA believes health care facilities should not use crisis capacity strategies any longer. Crisis capacity conservation strategies were previously recommended to address respirator shortages earlier during the COVID-19 outbreak.