Jun 4, 2026

IMPORTANT NOTICE: If you are using a legacy FDA ESG Portal, the content of this page applies. However, if you have transitioned to the ESG NextGen Portal, please contact the FDA ESG Help Desk to confirm certificate requirements for your account. Then, please follow the instructions from ESG NextGen AS2 Account Set-Up Steps to continue.

According to the latest update, submissions via Unified Submission Portal (USP) or API no longer require certificates, but if you are using an AS2 Gateway connection, you must still use digital certificates. To learn more about ESG NextGen, please refer to this FDA documentation. 

Prerequisites:

You should already have an FDA ESG account and have completed the following steps:

1. Download and Install PersonalSign Certificates
2. Export your public key 

Steps for the FDA ESG Account

1. Email the public key (.p7b) to ESGHelpDesk@fda.hhs.gov, providing the following information:

   1. Primary account holder's name

   2. Electronic Submissions Gateway Account name

2. A confirmation email from ESGHelpDesk@fda.hhs.gov will be received, notifying the account holder that the new public key has been uploaded. The user may now send submissions via the Electronic Submissions Gateway using the newly exports private key (.pfx).