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.
Attention ESG Community!
Revision of Delivery Method for Letter of Non-Repudiation Agreement
As of March 2, 2023, FDA revised regulatory guidance regarding the delivery method of the Letter of Non-Repudiation Agreement. Now, the FDA provides an option for electronic delivery of the Letter of Non-Repudiation Agreement and no longer requires a paper copy to be mailed to the FDA. Refer to the FDA ESG User Guide Appendix G: Letters of Non-Repudiation Agreement for more information.
These revisions are also extended to the delivery of the Letter of Authorization. For further information, view the FDA ESG User Guide Appendix K: Sample Authorization Letter.
ESG Next Generation!
The FDA is excited to share information on the modernization effort currently underway for the electronic submission process. Electronic Submission Gateway Next Generation (ESG NextGen) will eventually replace the Electronic Submission Gateway (ESG). Click on the "What's New? ESG NextGen" link above to learn more about this effort and obtain the most up-to-date information.
For ESG Related Questions