FDA revokes authorization for Battelle decontamination system

The Food and Drug Administration Friday revoked its emergency use authorization for Battelle Memorial Institute’s decontamination system for N95 respirators at Battelle's request.
“In response to changing customer needs, as of March 31, 2021, Battelle has ceased all Battelle CCDS decontamination site operations and marketing activities,” FDA said.
On April 9, FDA urged health care facilities to transition away from using crisis capacity conservation strategies such as decontamination or bioburden reduction to extend the use of N95s and other similar disposable respirators due to an increased domestic supply of new respirators.
Related News Articles
Headline
AHA May 23 submitted recommendations to the Department of Justice and Federal Trade Commission in response to the agencies’ requests for information on…
Headline
The AHA May 12 responded to the Office of Management and Budget's April 11 request for information on regulatory relief, making 100 suggestions to the Trump…
Headline
The Trump administration May 5 issued two executive orders on pharmaceutical manufacturing and life-sciences research. The first executive order, "…
Headline
The Centers for Medicare & Medicaid Services today released a notice seeking public comment on the collection of information request regarding the State…
Headline
The Food and Drug Administration yesterday released recommendations for streamlining the approval process for medical devices that use artificial intelligence…
Perspective
All of America’s hospitals and health systems are cornerstones of their communities. They not only deliver around-the-clock care and essential services to…