FDA Clarifies How AEMS Announcement Affects eMDR Submitters

eMDR System Enhancements https://www.fda.gov/medical-devices/emdr-electronic-medical-device-reporting/emdr-system-enhancements?utm_medium=email&utm_source=govdelivery The U.S. Food and Drug Administration is providing this update to enhance its recent press release announcing the launch of the new Adverse Event Monitoring System (AEMS) by clarifying how the system’s implementation affects eMDR submitters. In short: eSubmitter users will not experience any changes from this consolidation. AS2 or API (system-to-system) submitters will see no changes to the electronic submission format or address. However, the system will introduce minor updates to Ack3 error messages during this transition. The FDA recommends that submitters review additional details about rejection of ISO 3166-1 alpha-2 country codes and the timeline for updating, accepting, and utilizing new Adverse Event codes on the eMDR System Enhancements web page. The FDA also recommends that AS2 or API submitters verify system compliance with AEMS by sending test submissions to eMDR Test through ESG NextGen promptly. FDA Launches New Adverse Event Look-Up Tool For Immediate Release: March 11, 2026 https://www.fda.gov/news-events/press-announcements/fda-launches-new-adverse-event-look-tool?utm_medium=email&utm_source=govdelivery