The FDA recently announced its planned enhancements to the Electronic Medical Device Reporting (eMDR) System. The purpose of the announcement was to allow medical device companies who submit reports using AS2 (a system-to-system connection to exchange submissions with the FDA) early notice about the planned enhancements. The scheduled changes are as follows:
| Change | Comments | Schedule |
| Require Weight Unit if Weight is provided | If a number is provided in the weight field, then a weight unit must be selected. Submitters who send an MDR with a weight but without a weight unit selected will receive an Ack 3 rejection message. |
September 2024: Test deployment to eMDR. March 31, 2025: Production deployment to eMDR |
| 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 2024: Test deployment to eMDR. March 31, 2025: Production deployment to eMDR |
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International Medical Device Regulators Forum (IMDRF) 2024 maintenance updates
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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, will be released in August with the Implementation Package at Coding Resources | November 2024: eSubmitter users can begin using new codes. AS2 users to implement the new codes by March 31, 2025. |
The FDA also indicated the following schedule for future enhancements, with possible exceptions made for emergency fixes or major changes that may require more time between the release of the implementation package and production deployment:
- Announce upcoming enhancements in June,
- Release the Implementation Package in August,
- Deploy enhancements to pre-production (ESG Test) in September, and
- Deploy high-impact enhancements to production seven months after the Implementation Package is released, typically in March of the following year.
Should you need help with these changes or any other Regulatory or Quality Compliance support, please don’t hesitate to reach out to PRP!
