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Electronic medical device reporting update

This article was originally published in The Gray Sheet

Executive Summary

Companies may begin using new FDA device problem codes in their mandatory adverse event reports beginning July 1, the agency says. The new electronic Medical Device Reporting (eMDR) coding 1system revamps the previous system with specific improvements to patient and device problem codes, the inclusion of component codes to clarify the part of the device associated with the adverse event, and improvements to code descriptions and definitions, FDA says. Old MDR codes will still be accepted, but only until April 2, 2010 (2"The Gray Sheet" April 6, 2009)

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