FDA revokes Battelle mask decontamination EUA

The FDA has revoked its authorization for Battelle Memorial Institute to decontaminate used N95 respirators for healthcare workers.

In a letter dated April 30, 2021, the agency said it revoked the EUA at Battelle’s request. The Columbus, Ohio-based research organization asked to withdraw the EUA for its Critical Care Decontamination System (CCDS) in an April 2 letter. Battelle said it is no longer operating or marketing the vaporized hydrogen peroxide systems, according to the revocation letter.

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