FDA Revokes EUA For Battelle’s Mask Decontamination System

By Kelly Lienhard / April 30, 2021 at 6:40 PM
FDA on Friday (April 30) revoked emergency use authorization for Battelle’s respirator decontamination system after the company requested voluntary withdrawal of the EUA. According to FDA, Battelle asked that the EUA be withdrawn in response to changing customer needs. The company ceased all decontamination site operations and marketing activities on March 31. Battelle’s system received EUA from FDA in March 2020 in response to personal protective equipment shortages created by the COVID-19 pandemic. The system was authorized to decontaminate as...

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