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In Brief: MDR reporting forms

This article was originally published in The Gray Sheet

Executive Summary

MDR reporting forms: Manufacturers and user facilities must file medical device adverse event reports and other reports required under the agency's final MDR rule using standard FDA forms beginning April 11, 1996, 120 days after the reg's Dec. 11 publication date. An earlier draft of the reg, cited by "The Gray Sheet" (Dec. 11, p. 3), said mandatory use of the standard forms would begin 90 days after publication...
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