FDA Issues Proposed Rule and Draft Guidance on Electronic Submission of Medical Device Adverse Events

On August 21, 2009, the U.S. Food and Drug Administration published an important proposed rule in the Federal Register regarding postmarket medical device reporting and issued a related Draft Guidance. The proposed rule amends FDA’s postmarket medical device reporting regulations to require that manufacturers, importers, and user facilities submit mandatory reports of individual medical device adverse events to the agency in an electronic format that the agency can process, review, and archive. See 74 Fed. Reg. 42203. The Draft Guidance entitled Draft Guidance for Industry, User Facilities and FDA Staff eMDR- Electronic Medical Device Reporting (Draft Guidance) addresses general issues related to FDA’s proposed rule and provides information on how to prepare and send an electronic postmarket medical device report to the Center for Devices and Radiological Health (CDRH). The proposed rule is an effort by the agency to improve its process for collecting and analyzing postmarket device adverse event information. Similar proposed mandatory electronic reporting requirements were introduced for drug and biologic manufacturers. Comments to the proposed rule are due by September 21, 2009.


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