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[FDA News] eMDR System Enhancements

On June 30, 2023, the FDA announced the enhancements to the Electronic Medical Device Reporting (eMDR) system.

While the FDA eSubmitter client is updated simultaneously with the eMDR system, it is important for industries utilizing system-to-system, or AS2, accounts with the FDA Electronic Submissions Gateway (ESG) to review the information provided on this page and promptly plan system updates. This will ensure their systems are aligned with the enhanced eMDR system as soon as possible.

To address the need for early notice and predictability, the FDA acknowledges the significance of informing manufacturers who submit HL7 ICSR XML reports via AS2 about potential eMDR system changes. As a result, the FDA has established a regular schedule for implementing enhancements to the eMDR system. This approach aims to facilitate early preparation and readiness for upcoming modifications.

Under this schedule, the FDA plans to proceed with each cycle's next set of enhancements, ensuring a systematic approach to implementing updates.

  1. Announce upcoming enhancements in June,

  2. Release the Implementation Package in August,

  3. Deploy enhancements to pre-production (ESG Test) soon after the package is released, and

  4. Deploy high-impact enhancements to production 7 months after the Implementation Package is released, typically in March of the following year.

Regular updates and communications regarding the eMDR system enhancements will be posted on the following link at every stage of the process. Additionally, the information will be sent via email to the CDRH Industry's mailing list.

For detailed information on the 2023 eMDR system Enhancements, please refer to the following link:

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