White Paper: Issues Facing Device Manufacturers As F.D.A. Moves Closer To Mandating Electronic Reporting (eMDR)

In the coming months, F.D.A.'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 F.D.A.'s Electronic Submissions Gateway (ESG).

While e-submission of MDRs has been technically possible since late 2007, the lack of a mandate has slowed adoption of the platform. In addition, complexity in the formalized method for receiving acknowledgments from CDRH has made development of automated processing systems for eMDR challenging.

Transitioning from a paper-based system to an electronic reporting platform will require thought, planning, design, testing, and implementation. The purpose of this paper is to help identify many issues which will emerge during the transition process. In this discussion, emphasis is placed on careful upfront thought and planning. Thorough work on these fronts will ensure a smooth design phase, productive testing, and a successful implementation.