Issues Facing Device Manufacturers as F.D.A. Moves Closer to Mandating Electronic Reporting (eMDR)

06 July 2009 by Sparta Systems Europe

In the coming months, the FDA's Center for Device and Radiological Health (CDRH) is rumored to be issuing a rule that will establish a timetable for requiring electronic submission of Medical Device Reports (eMDRs). When the mandate for electronic submission becomes effective, MedWatch 3500A filers will no longer be permitted to submit paper reports, but will have to submit 3500As electronically. This includes device manufacturers, distributors, reprocessors, hospitals and physicians. The eMDR process will supplant the paper MedWatch report with a strictly formatted XML-format file that will be transmitted electronically through the FDA's Electronic Submissions Gateway (ESG).

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