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 using 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.