Electronic Medical Device Reporting Posts

FDA Final Ruling on electronic MedWatch reports: The Impact on the Industry

FDA Final Ruling on electronic MedWatch reports: The Impact on the Industry

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

Have you heard the big news? All mandatory 3500A MedWatch reports submitted by medical device manufacturers and importers must be now submitted electronically. On February 14, 2014, the FDA released its final decision on electronic Medical Device Reporting (eMDR). By August 14, 2015, all medical device manufacturers and importers will be required to submit mandatory 3500A MedWatch reports electronically to the FDA’s Center for Device and Radiological Health (CDRH). We’ve been waiting for this final decision since 2009 when the rule was proposed and opened for public comment. (more…)