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Policies/Guidance

What is ESG?

The Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG) is an Agency-wide solution for accepting electronic regulatory submissions. The FDA ESG is a highly scalable, easily available, high performance and secure exchange point for FDA and its partners to transact a variety of documents and submissions over industry-standard protocols. The FDA ESG enables the secure submission of premarket and postmarket regulatory information for review. The FDA ESG enables the FDA to process regulatory information automatically, functioning as a single point of entry for receiving and processing all electronic submissions in a highly secure environment.  The FDA ESG complies with secure Hypertext Transfer Protocol (HTTP) messaging standards and uses digital certificates for secure communication. The electronic submission process encompasses the receipt, acknowledgment of receipt (to the sender), routing and notification (to a receiving Center or Office) of the delivery of an electronic submission.

FDA ESG provides two methods, WebTrader and AS2, for making submissions to FDA.  FDA ESG has been in production since 2006 and is used by 100s of users to send 1000s of submissions every day.

  • WebTrader (WT): A web portal designed for low volume submitters. WT allows users to login, digitally sign and submissions, and view responses through a simple web interface.
  • AS2: A system-to-System connection to exchange submissions with FDA. AS2 requires a Gateway software implementation on submitters end.

Where do Submissions Go?

The FDA ESG is the central receipt point for sending information electronically to the FDA. Within that context, the FDA ESG is a conduit, or "highway", along which submissions travel to reach their final destination. The FDA ESG does not open or review submissions, but automatically routes them to the proper FDA Center or Office.  Industry Partners can send a receive documents from the Gateway via a web interface or server to server communications.

Contact Us

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