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Warning Letter Roundup & Recap – 13 October 2020

Executive Summary

Battelle Memorial Institute, which makes its Critical Care Decontamination System under emergency use authorization from the US FDA, was dinged by the agency for Medical Device Reporting violations. It’s the only device-related warning letter released by the FDA over the past week.

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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.

Device Week, 16 October 2020 – FDA Drops 3 Guidance Docs

On this week’s podcast: The US FDA was busy with draft and final guidance documents this week, issuing three within 24 hours. The docs address disparate device industry concerns, ranging from of-the-moment issues like coronavirus test supplies, to more traditional concerns around device materials testing.

US FDA Recognizes Case For Quality Collaborative Community

The Case for Quality Collaborative Community – or CfQcc – affords stakeholders across industry a safe space where they can rally around an array of topics to advance medical device quality and safety.

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