FDA Announces eMDR System Updates

The FDA has announced updates to the CDRH’s Electronic Medical Device Reporting (eMDR) system. These updates are crucial for manufacturers, especially those using system-to-system or AS2 accounts with the FDA Electronic Submissions Gateway (ESG), to align their systems with the new enhancements. 

Key Points: 

1. FDA’s proposed eMDR System update schedule:

• • June: Announce upcoming enhancements. 
  • August: Release the Implementation Package. 
  • September: Deploy enhancements to pre-production (ESG Test). 
  • March (following year): Deploy high-impact enhancements to production. 

2. Regular Updates and Communication:

• • The FDA will provide early notice of potential changes.
  • Regular updates will be posted on the FDA website and emailed to the CDRH Industry’s email list.

3. Testing and Support:

• • Manufacturers can use eMDR Test (via ESG Test) for system updates at any time.
  • For questions or concerns, you can contact the eMDR helpdesk at eMDR@fda.hhs.gov.

This schedule aims to offer predictability and ample preparation time for system updates, with flexibility for emergency fixes and major changes. Regular communications will ensure all stakeholders are informed throughout the process. You can read more about the FDA enhancements on their website here. 

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