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MDR summary reporting expansion planned by FDA; program begins with about 30 firms.

This article was originally published in The Gray Sheet

Executive Summary

SUMMARY MDR REPORTING PROGRAM TO BEGIN WITH 30 MANUFACTURERS that responded to FDA's request for participants mailed out July 31. Under the reporting schedule outlined in the agency's letter to firms, the first quarterly reports will be due in Jan. 31, 1998. FDA is in the process of sending letters of acceptance to the 30 companies participating in summary reporting. The letters note that the firms are exempt from regular MDR reporting requirements for events covered by summary reporting. FDA has identified types of events for the devices that qualify for summary reporting. Manufacturers also can propose additional types of events, but they would have to be reviewed by FDA.

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