Electronic Medical Device Reporting (eMDR) System Updates

The FDA recently updated the eMDR system to refine supplement report processing. The FDA also updated the eMDR System Status webpage with a new maintenance schedule for 2019. Are there new submission requirements? No, the submission requirements have not changed. However, submitters may experience new Ack3 acknowledgement messages as a result of this update. Why did the FDA update the eMDR system? The FDA modified supplement report processing to enforce requirements related to supplement report numbering. In the past, supplements sent with incorrect follow-up numbers (for example, a supplement #2 for a report without supplement #1) would be accepted and placed into “supplement hold” while the eMDR system waited for the missing supplement(s) to arrive. After the update, a supplement with an incorrect follow-up number will be rejected, and Ack3 will contain a message explaining which follow-up numbers are missing for the report in question. What are the new Ack3 error messages? The eMDR Implementation Package now includes sample acknowledgement files for these new Ack3 error messages. The package also contains a few corrections to the XML requirements that were published with the previous update in July 2018.

2019 eMDR Maintenance Schedule