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MANUFACTURER TREND ANALYSIS DELETED FROM FINAL MDR RULE; FIRMS GIVEN 30 DAYS TO REPORT MOST PROBLEMS, FIVE DAYS TO REPORT SERIOUS ADVERSE EVENTS

This article was originally published in The Gray Sheet

Executive Summary

Manufacturers will not have to compile adverse event trend analysis reports for FDA under a final medical device reporting rule slated for publication in the Dec. 11 Federal Register. Instead, FDA will conduct trend analyses on MDR reports that, for the most part, must be submitted within 30 days after a manufacturer learns of an event.
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