U.S. FDA Electronic Medical Device Reporting (eMDR)
The U.S. Food and Drug Administration (FDA) now requires medical device manufacturers and importers to submit mandatory initial and supplemental adverse event reports in electronic format through FDA’s Electronic Submission Gateway using a Web Trader Account. The process involves multiple steps such as submitting a letter of non-repudiation to FDA, obtaining a third party digital certificate, etc.
As your U.S. Agent for FDA communications, Registrar Corp will submit all of your reports in eMDR format at no additional cost.
Current U.S. Agent clients may upload their Medical Device Reports to Registrar Corp for submission to FDA in eMDR format now.