The FDA has added new information on our webpages about adverse event reporting requirements. The Electronic Medical Device Reporting (eMDR) System webpages help manufacturers, importers and health care facilities understand eMDR requirements and how to submit medical device reports electronically.
On August 14, 2015, the eMDR final rule went into effect, requiring manufacturers and importers to submit medical device reports to the FDA electronically rather than in paper form. Electronic submission expedites report processing and reduces the burden of data entry on the FDA, manufacturers, health care facilities, and importers.
The new pages are:
- How to Enroll in eMDR Program provides detailed instructions for enrolling in the eMDR program and completing the required guidance-compliant test submissions.
- eMDR Help and FAQs provides answers to common questions and who to contact when specific concerns arise.
- eMDR System Enhancements describes updates made to improve the eMDR system.
For eMDR submission questions, contact the appropriate help desk listed at the eMDR Help and FAQs page.
Food and Drug Administration
Center for Devices and Radiological Health