To submit MDRs electronically, you will need to set up a Webtrader Account and then submit test data that is successfully processed through the ESG before you receive a production account to use for your MDR submissions. Here is the process for beginning to file eMDRs:
- Request a Webtrader Account from the ESG.
- Submit a Letter of Non-Repudiation to FDA.3
- Obtain a personal digital certificate.4
- Submit test data. Prepare a test eMDR (a mock report and not an actual adverse event report) containing the information specified in the appropriate section of 21 CFR Part 803: 803.32 for user facilities, 803.42 for importers, or 803.52 for manufacturers.
- Receive a production account from the ESG. CDRH will notify ESG to provide you with the production account once you have completed successful testing.
- Use the production account to send your actual eMDRs to FDA.
