MDR summary reports initially would supplement standard reports under "reengineering" concept.
This article was originally published in The Gray Sheet
Executive Summary
MDR SUMMARY REPORTING WOULD SUPPLEMENT CURRENT REPORTING REQUIREMENTS in the short-term under a reengineering proposal being crafted by FDA's Center for Devices and Radiological Health. The proposal ultimately is intended to allow manufacturers to report many adverse events in summary form rather than individually. However, until current medical device reporting rules are revised, manufacturers would voluntarily submit summary reports in addition to individual event reports.