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FDA Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Device tracking: 1Medical device tracking final rule amending 1993 reg to reflect changes under FDAMA is effective May 9. No revisions are made to the April 25, 2000 proposed rule (2"The Gray Sheet" May 1, 2000, In Brief). The rule "makes no revisions to the regulation's existing system and content tracking requirements, the current obligations of persons other than device manufacturers, such as distributors, records and inspection requirements and existing record retention requirements." A final guidance on medical device tracking was issued Jan. 24, 2000...
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