U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Device Advice: Comprehensive Regulatory Assistance
  4. Postmarket Requirements (Devices)
  5. Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities
  6. eMDR – Electronic Medical Device Reporting
  7. FDA Electronic Submissions Gateway Next Generation (ESG NextGen)
  1. eMDR – Electronic Medical Device Reporting

FDA Electronic Submissions Gateway Next Generation (ESG NextGen)

eMDR uses the FDA Electronic Submissions Gateway Next Generation (ESG NextGen), an agency-wide entry point for all electronic submissions, to receive electronic MDRs. The FDA ESG NextGen (also referred to as the ESG NextGen or the Gateway):

  • Enables the FDA to process regulatory submissions automatically
  • Functions as a single point of entry for the receipt and processing of all electronic submissions in a secure
    environment that complies with secure messaging standards
  • Serves as a conduit, or “highway,” along which submissions travel to reach their final FDA destination
  • Automatically routes submissions to the appropriate FDA Center or Office.

The electronic submission process through the ESG NextGen encompasses the receipt, acknowledgment of receipt (to the sender), routing, and notification (to a receiving FDA Center or Office) of the delivery of an electronic submission. For more information, please visit, the FDA Electronic Submissions Gateway Next Generation (ESG NextGen). 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.

Back to Top