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FDA's eMDR program will soon be mandatory

This article was originally published in The Silver Sheet

Executive Summary

FDA is urging device manufacturers to begin using the agency's electronic Medical Device Reporting (eMDR) program in anticipation that they will be required to do so as early as next spring. Currently, the eMDR program - which aims to improve CDRH's ability to analyze adverse event reports so it can identify troubling patterns more efficiently - is voluntary ("The Silver Sheet" August 2007). However, that will change once the agency issues a final rule on the program early next year, Don St. Pierre, CDRH associate director for postmarket transformation, said Sept. 25 at the Regulatory Affairs Professionals Society (RAPS) annual conference in Boston. "You can do [electronic reporting] now or you can wait for it to be done to you," he said, noting that so far only 15 eMDRs have been filed with FDA, all by one company

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