Decontamination, N95 masks, coronavirus, COVID-19

FDA Revokes EUA for Battelle Decontamination System

By MedTech Intelligence Staff
Decontamination, N95 masks, coronavirus, COVID-19

The CCDS system was used to decontaminate compatible N95 respirators for multiple re-use.

Last week the FDA revoked the emergency use authorization (EUA) granted to Battelle’s Critical Care Decontamination System (CCDS). The agency’s move was made after Battelle requested the voluntary withdrawal of the authorization and confirmed that it stopped the operation of the CCDS at sites, along with any marketing activities.

Battelle received the EUA on March 28, 2020 during a time of critical need during the beginning of the COVID-19 pandemic. It was authorized to decontaminate a N95 mask up to 20 times.

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