FDA MDR Final Revised Guidance

FDA published a final guidance “Medical Device Reporting for Manufacturers” dated Nov. 8, 2016. This supesedes the prior 2013 draft and 1997 guidances. It contains significant Q&A which helps clarify FDA’s ongoing interpretation of enforcement of the 21 CFR 803 regulation itself. This guidance appears to be providing clarification consistent with their interpretations since the MDR rule itself was published rather then any significant changes in interpretation or enforcement. Page 3 of this guidance provides a phone # 301-796-6670 and email: MDRPolicy@fda.hhs.gov for questions about this guidance or the regulation.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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