In the coming months, 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 fi lers 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).