The U.S. Food and Drug Administration (FDA) issued a Letter to Health Care Personnel and Facilities on May 27, 2021.

The FDA is recommending health care personnel and facilities transition away from crisis capacity conservation strategies, such as using non-NIOSH-approved disposable respirators, including non-NIOSH-approved imported respirators such as KN95s. This recommendation is in follow-up to the April 9, 2021, letter in which the FDA recommended a transition away from decontamination or bioburden-reduction systems for cleaning and disinfecting disposable respirators, which were being reused by health care personnel.

Based on the increased domestic supply of new 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, the FDA believes health care personnel and facilities can transition away from using non-NIOSH-approved respirators and from utilizing decontamination and bioburden reduction systems. These crisis capacity conservation strategies have been used to address respirator shortages during the COVID-19 outbreak.

Please see the attachment for full details.

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