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!

FDA ESG is announcing new certificate generation tool for the purpose of generating a signing certificate for FDA ESG use. All existing and new ESG WebTrader users can utilize this tool to generate a certificate for new accounts and replacing expiring certificates. Check our certificates page for more information certificates.

https://esgcertificate.assyst.net/External Link Disclaimer

Note that this tool generates a self-signed certificate for signing, it cannot be used for encryption. If you are a Gateway-to-Gateway (AS2) user, you must obtain your own encryption certificate.

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.