• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » FDA revokes EUAs for certain respirators, decontamination systems after increased N95 access

FDA revokes EUAs for certain respirators, decontamination systems after increased N95 access

July 1, 2021 By Sean Whooley

FDA U.S. Food and Drug AdministrationThe FDA issued a briefing confirming the revoking of emergency use authorizations (EUAs) for certain respirators and decontamination systems.

EUAs for all non-NIOSH (National Institute of Occupational Safety and Health)-approved disposable respirators, including disposable respirators like KN95s, along with decontamination and bioburden reduction systems, were all revoked, having been issued amid the COVID-19 pandemic.

According to an FDA release, the actions were consistent with the updated CDC recommendations for healthcare facilities to not use crisis capacity strategies and promptly return to conventional practices. Manufacturers of decontamination and bioburden reduction systems requested — and the FDA agreed to — the revocation of their EUAs, effective June 30.

NIOSH approved more than 875 respirator models or configurations since the beginning of the pandemic. The EUA revocations apply to all non-NIOSH approved, disposable facepiece respirator models, while the FDA withdrew two related decontamination and bioburden reduction guidance documents.

“Throughout the pandemic, the FDA has worked closely with our federal partners at the Centers for Disease Control and Prevention’s National Institute for Occupational Safety and Health (NIOSH), the Occupational Safety and Health Administration (OSHA) and with manufacturers to protect our front-line workers by facilitating access to the medical supplies they require,” said Dr. Suzanne Schwartz, director of the Office of Strategic Partnerships and Technology Innovation in the FDA’s Center for Devices and Radiological Health Dr. Suzanne Schwartz.

“As a result of these efforts, our country is now better positioned to provide health care workers with access to NIOSH-approved N95s rather than using non-NIOSH-approved respirators or reusing decontaminated disposable respirators,” Schwartz said in the news release.

Schwartz went on to note that, early in the public health emergency, the need for such EUAs was evident, regardless of NIOSH approval. Those conditions no longer exist, she said, as the national supply of NIOSH-approved N95s is more accessible to healthcare workers.

“Today, the FDA is taking additional action by announcing the revocation of EUAs for imported, non-NIOSH-approved respirators as well as decontamination and bioburden reduction systems because of an increase in domestically-manufactured NIOSH-approved N95s available throughout the country,” Schwartz said. “As access to domestic supply of disposable respirators continues to significantly improve, health care organizations should transition away from crisis capacity conservation strategies that were implemented at the onset of the pandemic.”

Filed Under: Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Respiratory Tagged With: coronavirus, COVID-19, FDA

More recent news

  • Medtronic partners with IRCAD on Hugo, Affera surgical training
  • 23andMe co-founder wins bid to take back control of company
  • Neurent Medical opens new manufacturing facility in Ireland
  • Brain Navi wins FDA nod for neurosurgical robot
  • Adona Medical completes enrollment in first-in-human interatrial shunt trial

About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy