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eMDR Enhancements: FDA Rolls Out Regular Updates

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The FDA is now implementing enhancements to the Electronic Medical Device Reporting (eMDR) system on a regular schedule except for emergency fixes that may need to be implemented outside the regular schedule.

Through this schedule, the FDA expects to take the next steps for every cycle of new enhancements: 

    • Announce upcoming enhancements in June
    • Release the Implementation Package in August
    • Deploy enhancements to pre-production (ESG Test) in September
    • Deploy high-impact enhancements to production 7 months after the Implementation Package is released, typically in March of the following year

 

It is also noted that if major system changes are necessary in the future, additional time will be provided between release of the implementation package and production deployment.

The FDA believes these steps will aid industry with system-to-system, or AS2, accounts with the FDA Electronic Submissions Gateway (ESG) to plan their own system updates to align with FDA’s planned eMDR system enhancements.

Some of the relevant eMDR system planned changes coming up are listed below:

Change                Comments                Schedule
Require all Adverse Event codes in initial MDRs All Adverse Event codes accepted in sections F10 and H6 of the Form 3500A will be required in initial manufacturer and importer reports. All code types have codes that can be used when there is not enough information to select a meaningful code; for more information, see How to Code an MDR Adverse Event Report. Submitters who send an MDR without at least one valid code for each code type will receive an Ack 3 rejection message September 20, 2024: Test deployment to eMDR.

March 31, 2025: Production deployment to eMDR
International Medical Device Regulators Forum (IMDRF) 2024 maintenance updates The Adverse Event codes accepted in sections F10 and H6 of the Form 3500A will be updated to harmonize with maintenance updates from IMDRF. A summary of the changes and the new hierarchy files, was released in August with the Implementation Package at Coding Resources for Medical Device Reports. September 20, 2024: Test deployment to eMDR.

November 8, 2024: eSubmitter users can begin using new codes. AS2 users to implement the new codes by March 31, 2025.

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