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FDA device reporting conference

This article was originally published in The Gray Sheet

Executive Summary

To discuss medical device reporting requirements for manufacturers, distributors and user facilities will be held July 13 in Rockville, Maryland. Topics to be addressed include adverse incident reporting, "guidelines, instructions and forms." The meeting also will address the electronic reporting pilot program and the partial draft standard for reporting events by electronic media. The meeting and availability of the standard on electronic data interchange (EDI) were announced in a June 25 Federal Register notice. For further information, contact Joan Rudick at 301/427-1156.
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