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FDA MDR rule speaks plainly

This article was originally published in The Gray Sheet

Executive Summary

Direct final rule to translate FDA's medical device reporting rule into plain language will become effective July 13, FDA confirms. The agency received 16 comments, including letters from NEMA and AdvaMed, urging it to make revisions to the MDR reg before moving forward with the final rule (1"The Gray Sheet" May 30, 2005, p. 6). However, FDA has decided to implement the plain language modifications as initially proposed in February. FDA "did not receive any significant comment on the plain language revisions," FDA explains in the Federal Register notice...

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