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  7. FDA Electronic Submissions Gateway Next Generation (ESG NextGen)
  1. eMDR – Electronic Medical Device Reporting

FDA Electronic Submissions Gateway Next Generation (ESG NextGen)

Update: April 13, 2026

As of April 14, 2025, the ESG NextGen Unified Submission Portal (USP) replaced the legacy WebTrader user interface. This user-friendly web-based platform provides the ability to submit regulatory information to the FDA and track the status through Center receipt.   

eMDR uses the FDA Electronic Submissions Gateway Next Generation (ESG NextGen), an agency-wide receipt point for sending information electronically to the FDA.

Within that context, the FDA ESG NextGen is a conduit, or "highway", along which submissions travel to reach their final destination. The ESG NextGen automatically routes submissions to the proper FDA Center or Office. Industry Partners can send or receive documents from the Gateway through a web interface or server to server communications.

For more information, please visit the Electronic Submissions Gateway Next Generation (ESG NextGen) webpage. If you have any questions regarding the registration process or the Gateway in general, please contact the help desk as indicated on the ESG NextGen website.

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