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CDRH ready for eMDR testing

This article was originally published in The Gray Sheet

Executive Summary

FDA's device center announces it is ready to start testing electronic submissions of medical device reports under its eMDR program. In the works for several years, the program aims to improve the center's ability to detect more critical adverse event reports among the more than 200,000 adverse event submissions it receives annually. Most of the submissions currently are sent in by fax, and must be typed in manually by data entry contractors. The project is one component of the center's expansive postmarket "transformation" initiative (1"The Gray Sheet" Feb. 20, 2006, p. 12). CDRH is accepting eMDR submissions from anyone who would like to participate. The program eventually will be mandatory as FDA moves to go completely electronic...
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