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Battelle Closes Sites, Asks FDA To Pull Mask Decontamination EUA

The US agency has pulled the emergency use authorization for Battelle’s face mask decontamination system after a request from the company, which has also closed sites where masks were being decontaminated.

A surgical N95 respirator mask among a sea of construction N95 respirators and face masks

In a further sign the need for medical face masks are not as dire as they were at the start of the coronavirus pandemic, the US Food and Drug Administration has withdrawn Battelle Memorial Institute’s emergency use authorization (EUA) for its mask decontamination system.

Battelle was granted an EUA by the FDA for its Critical Care Decontamination System (CCDS) in March 2020 after grave concerns that health care workers didn’t have enough N-95 respirators...

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