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.
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The US FDA has issued an emergency use authorization for a Battelle decontamination system to clean N95 masks, which are currently facing a shortage due to the COVID-19 pandemic. The company says it can clean up to 80,000 respirator masks a day from participating health care providers.
The tools include new laboratory methods, and computational models and simulations give the agency more capabilities to test and validate data in premarket submissions.
The US FDA’s latest report on non-regulated health and medical software finds they are not associated with any substantial increase in risks, though the agency admits there may be some underreporting.