Regulatory News In Brief
This article was originally published in The Gray Sheet
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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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)