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FDA GUIDANCE ON TREND ANALYSIS OF ADVERSE EVENTS UNDER MDR

This article was originally published in The Gray Sheet

Executive Summary

FDA GUIDANCE ON TREND ANALYSIS OF ADVERSE EVENTS UNDER MDR is due out by the end of the year, Janet Arrowsmith-Lowe, acting director of the device center's Office of Surveillance and Biometrics, said during a Sept. 27 teleconference on upcoming changes to the agency's medical device reporting (MDR) regulations. The agency currently is "working with industry to develop standardized methods of trend analysis," with the expectation of having a guidance document on "how to apply methodologies" available to manufacturers by the end of the year, Arrowsmith-Lowe said. Industry groups providing input to the agency include the Health Industry Manufacturers Association and the National Electrical Manufacturers Association.

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