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MDR reg effective date extension planned by FDA; baseline reporting changes likely.

This article was originally published in The Gray Sheet

Executive Summary

MANUFACTURER MDR ANNUAL CERTIFICATION: EASING OF LANGUAGE is under consideration by FDA and likely will be included in the final version of the annual certification form for manufacturer medical device reporting. Speaking at a Feb. 7 session of a Regulatory Affairs Professionals Society meeting in Bethesda, Maryland, Chester Reynolds, associate director of the device center's Office of Surveillance and Biometrics, said that in response to industry concerns the agency is "discussing modifying the statement on the form" to make it less "absolute," and instead indicate all reportable events were submitted to the agency "to the best of [the manufacturer's] knowledge."

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