Breathing Safely: FDA’s Reissue of Emergency Use Authorization of NIOSH-Approved Respirators for Healthcare

Throughout the course of the COVID-19 pandemic, the FDA has issued Emergency Use Authorization (EUA) of various types of personal respiratory protection for healthcare workers, primarily due to the shortages of disposable face mask options. The exact details of this EUA has changed a number of times, with the most recent updates going into effect in July 2021.

Here’s a breakdown of what you need to know about these latest updates.

What Was Included in the FDA’s First EUA During the COVID-19 Pandemic?

In early March 2020, the FDA issued a letter authorizing emergency use of:

• All disposable filtering facepiece respirators (FFRs or respirators) approved by NIOSH, in accordance with 42 CFR Part 84, as non-powered air-purifying particulate FFRs
• FFRs that were NIOSH-approved but had since passed the manufacturers’ recommended shelflife

Later that same month, the FDA reissued its EUA, amending the scope to include additional respiratory protection options for healthcare workers. The updates included:

• Non-powered air-purifying particulate FFRs and reusable respirators, such as elastomeric half- and full-facepiece respirators, approved by NIOSH in accordance with 42 CFR Part 84 and listed on the NIOSH Certified Equipment list (CEL) for non-powered air purifying respirators with particulate protection
• Other powered air purifying respirators (PAPRs) approved by NIOSH, in accordance with 42 CFR Part 84, and that are listed on the NIOSH CEL for PAPRs with particulate protection
• FFRs that were NIOSH-approved but have since passed the manufacturers’ recommended shelflife; are not damaged; and have been held in accordance with manufacturers’ storage conditions in strategic stockpiles
• Any authorized respirator under (1) or (3) above that has been decontaminated pursuant to the terms and conditions of an authorized decontamination system

What Are Latest Changes to the EUA?

In June 2021, the FDA concluded that, based on the increased domestic supply of respirators approved by the CDC and NIOSH, and the latest CDC and OSHA guidelines for protecting healthcare workers, healthcare facilities should no longer use crisis capacity strategies.

The FDA announced that the original EUA no longer authorizes use of decontaminated or non-NIOSH approved disposable FFRs, or respirators that are beyond the manufacturer-designated shelflife. The FDA also revoked the remaining decontamination system and bioburden reduction EUAs.

The updated and reissued EUA went into effect on July 6, 2021, and now includes only NIOSH-approved respirators which can be cleaned, disinfected and reused in healthcare settings in response to the ongoing COVID-19 pandemic. This reissue limits the scope of the EUA to include:

• Non-powered air-purifying particulate FFRs and reusable respirators, such as elastomeric half- and full-facepiece respirators, approved by NIOSH in accordance with 42 CFR Part 84 and listed on the NIOSH Certified Equipment list (CEL) for non-powered air purifying respirators with particulate protection
• Other powered air purifying respirators (PAPRs) approved by NIOSH, in accordance with 42 CFR Part 84

This latest update remains in effect until the FDA declares that circumstances exist justifying the authorization of the emergency use of personal respiratory protective devices during the COVID-19 outbreak is terminated or the EUA is revoked.

[Editor’s Note: This article first appeared on MSA Safety’s blog. For the original article, go to https://blog.msasafety.com/what-the-fdas-reissue-of-emergency-use-authorization-of-niosh-approved-respirators-means-for-healthcare/.]

For further reference, more details about the EUA updates can be found here:

https://www.fda.gov/medical-devices/letters-health-care-providers/update-fda-recommends-transition-use-non-niosh-approved-and-decontaminated-disposable-respirators 

https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/historical-information-about-device-emergency-use-authorizations#ppe