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FDA Guidances Cover Decontamination, Bioburden Reduction Systems For COVID-19 Masks, Respirators

 
• By Sue Darcey

In a pair of guidance documents the US agency explains clearance options and its enforcement policy for sponsors of devices used to reduce contaminants in COVID-19 masks and respirators.

Infected patient in quarantine lying in bed in hospital, coronavirus concept.

In a policy aimed at aiding the safe reuse and conservation of surgical masks and respirators during the COVID-19 pandemic, the US Food and Drug Administration has recommended ways sponsors could win clearance of mask and respirator decontamination devices. The agency also updated and reissued an enforcement policy guidance on masks and respirators.

The first guidance, “Recommendations for Sponsors Requesting EUAs for Decontamination and Bioburden Reduction Systems for Surgical Masks and Respirators, etc.,” acknowledges that there presently are no cleared or approved...

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