How to Report (eMDR / MedWatch 3500A)
eMDR — Electronic MDR system
Since 2014, FDA requires electronic submission of MDRs via the eMDR system for all manufacturers and importers. User facilities may submit electronically or via paper.
eMDR submission methods:
- FDA ESG (Electronic Submissions Gateway) — for high-volume submitters submitting in or ICH E2B(R3) (recommended for first-time MDR submitters) HL7 ICSR format
- CDRH eSubmitter — for lower-volume submitters using a guided web-based interface
MedWatch 3500A
FDA Form MedWatch 3500A is the mandatory reporting form for mandatory MDR reporters (manufacturers, importers, user facilities). It captures:
- Patient information (age, sex, weight)
- Adverse event / product problem description
- Suspect device information (brand name, manufacturer, model, lot number, UDI)
- Relevant concomitant devices
- Narrative description of event
- Outcome of event
- Reporter information
Voluntary reporting
Healthcare professionals, patients, and caregivers may voluntarily report using MedWatch 3500 (voluntary form). These voluntary reports feed into the MAUDE database.
MAUDE database
All submitted MDRs (mandatory and voluntary) are entered into the MAUDE (Manufacturer and User Facility Device Experience) database, which is publicly searchable at accessdata.fda.gov.
Official resources
After submitting via eMDR, manufacturers receive an electronic confirmation number. FDA's CDRH typically sends written acknowledgment of receipt within 30 days. Manufacturers should retain submission documentation and tracking numbers for regulatory inspection purposes. Contact FDA's Office of Surveillance and Biometrics if confirmation is not received within 45 days.