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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

MDR coding revamp: CDRH has a new 1Web site to help companies understand the new Medical Device Reporting (MDR) coding system that goes live July 1, marking the system's first redesign since its inception. FDA is addressing limitations of the current system, which has undefined or ambiguous codes, no formal process to request new codes and no hierarchical structure (2"The Gray Sheet" March 3, 2008, p. 9). Come July 1, the new codes can be used in Form 3500A mandatory adverse event reports, as well as any other device-related event reporting, such as clinical study and patient safety reporting. FDA anticipates it will stop accepting the old codes by April 2010
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