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.
New WebTrader Account Approval Process:
Effective February 20, 2017, ESG will implement a new, streamlined process for account activation, resulting in reduced processing time for companies with existing production WebTrader accounts. Submission of the guidance compliant test will no longer be required, and the new process will be as follows:
- Send a small connectivity test to “GWTEST” center to confirm that connectivity to ESG is successful and that acknowledgements transmit.
- Notify ESGHelpDesk@fda.hhs.gov that the connectivity test is complete. Be sure to include the company name for verification.
- The ESG Help Desk will confirm WebTrader access and proceed with Production account approval.
If you have questions regarding this change, please email ESGHelpDesk@fda.hhs.gov.
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”.
For ESG Related Questions