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Holder Of EUA Gets FDA Warning Letter For Not Satisfying MDR Reporting Requirements

Battelle Memorial Institute, an N95 respirator decontamination system maker, has been back-and-forth with regulators about its Medical Device Reporting protocols, which the US FDA says is lacking. Battelle was granted an emergency use authorization by the agency for its CCDS Critical Care Decontamination System to decontaminate N95 respirators back in March.

Vintage inscription made by old typewriter, warning

The US Food and Drug Administration handed N95 respirator decontamination company Battelle Memorial Institute a warning letter on 7 October for not taking satisfactory measures when reporting medical device adverse events that were agreed upon in its emergency use authorization (EUA).

The letter – addressed to Jeff Rose, Battelle’s VP for government relations – said that despite months of interactions with the company about its Medical Device Reporting (MDR) procedures, it...

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