For Industry

Electronic Submissions Gateway

ESG Overview

The Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG) is an Agency-wide solution for accepting electronic regulatory submissions. The FDA ESG enables the secure submission of premarket and postmarket regulatory information for review.

The FDA ESG is the central transmission point for sending information electronically to the FDA. Within that context, the FDA ESG is a conduit along which submissions travel to reach the proper FDA Center or Office.

What's New

ESG 2.0 - Phase 2 Release:

This release included an upgrade of existing hardware, allowing industry to make submissions more efficiently. Additional benefits include:

  • Increased uptime;
  • Increased mobility - Access submission files, receipts, and acknowledgements from any device (e.g., PC, Mac, tablet, smartphone);
  • Enhanced user experience via the new interface;
  • Concurrent document submissions within WebTrader;
  • Expanded browser compatibility to IE 11, Firefox, and Chrome.


AS2 Systems:

The FDA Electronic Submission Gateway (ESG) updated ciphers and SSL protocols on Saturday, January 20, 2018 at 9:00 PM EST: 

  • SSL Protocols
    • TLS 1.2
  • Cipher Suites (suites in server-preferred order)
    • TLS 1.2
      • TLS_RSA_WITH_AES_128_CBC_SHA (0x2f)
      • TLS_RSA_WITH_AES_256_CBC_SHA (0x35)
      • TLS_RSA_WITH_AES_128_CBC_SHA256 (0x3c)
      • TLS_RSA_WITH_AES_256_CBC_SHA256 (0x3d)


Contact Us

For ESG Related Questions


Page Last Updated: 03/21/2018
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