In a new 47-page guidance the Food and Drug Administration (FDA) appears to be doing its best to cover the waterfront for medical device manufacturers who need to better understand the complex medical device reporting (MDR) requirements. Topics range from the big picture (who is subject to this rule) down to specifics (how many times must a manufacturer call a user facility for information before it can close the file).

In a perfect world, the FDA would pick an intelligent, telegenic representative and provide this information in a live Q&A format with follow-up questions from the audience. Until that day, we’ve got to rely on the new guidance, published July 9, 2013.

Medical device reporting is the FDA’s mechanism to work with medical device companies to identify and monitor adverse events, with an eye to detecting and correcting problems as quickly as possible.

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