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  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 (ESG)
  1. eMDR – Electronic Medical Device Reporting

FDA Electronic Submissions Gateway (ESG)

eMDR uses the FDA Electronic Submissions Gateway (ESG), an agency-wide entry point for all electronic submissions, to receive electronic MDRs. The FDA ESG (also referred to as the ESG 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 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 (ESG). If you have any questions regarding the registration process or the Gateway in general, please contact the help desk as indicated on the ESG website.

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