Knocking on Your Virtual Door: A Guide to FDA’s Remote Regulatory Assessments

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ARTICLE SUMMARY:

FDA’s medical device inspection branch officially launched what it calls the “Remote Regulatory Assessments” program in February. Trang Cox, a device inspector at FDA, recently provided an overview of how to participate in the program and what to expect.

FDA dispensed with routine onsite inspections in the early days of the pandemic, but it is only in the past few months that the agency’s device inspection cadre has launched an official program for conducting remote audits. The Remote Regulatory Assessments (RRA) program was stood up by the medical device section of FDA’s Office of Regulatory Affairs in mid-February.

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