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

Upcoming ESG 2.0 - Phase 2 Release:

This release will upgrade 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.

The new WebTrader requires users to install a new WebTrader client. More details regarding this change will sent via the WebTrader listserv.

If you have comments, questions, or concerns please email ESGHelpDesk@fda.hhs.gov with the subject line “ESG Second Generation Phase 2”.

Contact Us

For ESG Related Questions
Email: ESGHelpDesk@fda.hhs.gov

 

Page Last Updated: 08/11/2017
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