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Firms can now use new FDA adverse event problem codes

This article was originally published in The Silver Sheet

Executive Summary

Manufacturers are now able to use new FDA device problem codes in their adverse event reports, the agency says. The new electronic Medical Device Reporting (eMDR) coding system revamps the previous system with 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. Old MDR codes will still be accepted, but only until April 2, 2010. The eMDR program aims to make it easier for CDRH to analyze adverse event reports and identify troubling patterns more quickly ("The Silver Sheet" January 2009). Firms currently are not required to submit their MDR reports electronically
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