Device problem codes updated on new Web site
This article was originally published in The Silver Sheet
Executive Summary
FDA has launched a Web site to notify device manufacturers, importers and user facilities of changes to the agency's list of device problem codes that must be included in adverse event reports. The Web site - found at www.fda.gov/MedicalDevices/safety/reportaproblem/eventproblemcodes/default.htm - provides information on the agency's enhanced patient and device problem code list, and reminds firms that no old codes will be accepted on Medical Device Reporting (MDR) reports after April 2. CDRH and the National Cancer Institute teamed up to enhance the codes ("The Silver Sheet" September 2008)