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
The Department of Health and Human Services has delegated the Centers for Medicare & Medicaid Services certain statutory authorities to exclude individuals…
Headline
Multiple changes to transparency in coverage requirements for insurers were finalized Oct. 5 by the Departments of the Treasury, Labor, and Health and Human…
Headline
The House Ways and Means Committee July 1 voted along party lines to advance a bill, H.R. 9504, the Tax-Exempt Hospitals Transparency Act, that would add…
Headline
The Department of Health and Human Services published an interim final rule May 7 to delay compliance dates for entities receiving federal financial assistance…
Headline
The Centers for Medicare & Medicaid Services and the Food and Drug Administration April 23 announced a new pathway to expedite access to certain FDA…
Headline
The Department of Justice April 20 published an interim final rule in the Federal Register to delay compliance dates for certain regulatory requirements…