eMDR Troubleshooting and Contact Information
Update: April 10, 2026
As of April 14, 2025, the ESG NextGen Unified Submission Portal (USP) replaced the legacy WebTrader user interface. This user-friendly web-based platform provides the ability to submit regulatory information to the FDA and track the status through Center receipt.
Multiple helpdesks are available to assist eMDR submitters with common issues. If your issue is related to the Acknowledgments (Ack1, Ack2, Ack3, or Ack4) during the submission process, refer to the specific helpdesk below.
Troubleshooting
Reporters who experience technical issues other than missing acknowledgements should review this troubleshooting section before emailing the specific helpdesk to request support.
| Issue | Resolution |
|---|---|
| I am experiencing an error in USP. | Email the ESG NextGen HelpDesk at ESGNGSupport@fda.hhs.gov and request support. |
| I am experiencing an error in eSubmitter. | Email the eSubmitter Helpdesk at eSubmitter@fda.hhs.gov and request support. |
| Ack3 and Ack4 says my report failed due to a "duplicate report" error | This error means that eMDR has already accepted a report with this report number. If this is a supplemental report, verify that it is marked as a follow-up and has the correct follow-up number. If you are submitting a test report to eMDR Test, note that may contain reports received in production. Test submissions should always have report numbers that have never been used before on any MDR. |
| I am a high-volume submitter and I get the "duplicate report" error on the first submission of a report. | Email the eMDR Helpdesk at eMDR@fda.hhs.gov and request that they look up the core ID for the report with the report number in question. Your system may have sent the same report twice, or there could be some other technical issue. |
| Ack3 and Ack4 says my report failed due to having an invalid report number | This error means that the report number you provided was not valid. Every report (even test reports sent to eMDR Test) must include a current and valid FEI or CFN number in the first part of the report number. The eMDR Test will also reject reports with a very high calendar year (ex. 9000). The sequence number in the third and final part of the report number should always have five digits, and the first report of each year should have sequence number 00001. |
| Ack3 and Ack4 says that my report failed due to an invalid adverse event code. | This error means that one of the codes you provided in the Adverse Event Code fields (fields F10 or H6 of the FDA MedWatch 3500A form) was not valid. Please remove the invalid code, choose the most appropriate code using the FDA MDR Adverse Event Codes website, and resubmit. If you are using eSubmitter, make sure that you have the latest version using the Help > About dialog section. |
| Ack3 and Ack4 says my report failed due to having an invalid state code. | This error means the state code you entered in one of the address fields was not a valid U.S. state code. If you are entering a non-U.S. address, please include the state/province in the City field. |
| Helpdesk Name | Common Issues Handled | |
|---|---|---|
| ESG NextGen Helpdesk | ESGNGSupport@fda.hhs.gov | Ack1 or Ack2 not received |
| CDRH Electronic Submissions Helpdesk | CeSubHelpDesk@fda.hhs.gov | Ack3 or Ack4 not received |
| eMDR Helpdesk | eMDR@fda.hhs.gov | Ack3 or Ack4 received with failure |
If you have additional technical questions, please visit our Frequently Asked Questions webpage.