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 WebTrader submitters!

On Saturday, August 20, 2022, the FDA ESG (Electronic Submissions Gateway) program team implemented the ESG Account Management Portal (AMP).

ESG Account Management Portal URL:    https://esgportal.fda.gov

What’s new in this release!

1. The Account Management Portal enables users to easily navigate the account creation and management process. WebTrader users can register for account, update passwords and digital certificates, upload non-repudiation and authorization letters, and search for submission status.
2. ESG AMP introduces a new role, Industry Power User, to manage company specific account information and search for submissions by company accounts.

FAQs

1. How do I learn more about the new Account Management Portal?
   The ESG Account Management Portal User Guide is accessible on this webpage above via the label "ESG Account Management Portal User Guide". It is located at https://www.fda.gov/industry/about-esg/esg-account-management-portal-user-guide. Please contact [email protected] if assistance is required.
2. Does this release affect AS2 users?
   No. AS2 users continue to use current registration and onboarding process.