For Industry

Electronic Submissions Gateway

ESG Overview

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.

What's New

WebTrader Upgrade

Beginning Monday, June 25, 2018, WebTrader users will be able to use the upgraded WebTrader client.

What Can I expect after the upgrade?

WebTrader users may be prompted with a pop-up window stating “A New Version of User Services is Available!” After downloading and installing the newest version of the WebTrader client, this window will no longer appear.
You can also choose to keep the current WebTrader client and continue to send submissions without an interruption in service.

What happens if I don't upgrade or install the new client?

Nothing! You can continue to use WebTrader and send submissions to FDA. However, we do recommend that you download and install the updated WebTrader client within 90 days for the best performance possible.

 

New Ticketing Interface

Beginning Monday April 2, 2018, ESG will introduce a web interface to submit and access tickets to all ESG users. This new web interface will allow ESG users to submit tickets, view ticket updates, view the history of all tickets (including closed tickets), and access FAQs based on the ticket Request Type. Below are some additional details on how to access new help desk web interface:

  1. ESG users may continue to send emails to esghelpdesk@fda.hhs.gov to create tickets and receive response from ESG Help Desk.
  2. ESG users may also submit tickets directly to the FDA via https://esghelpdesk.fda.gov.
  3. Sending an email to esghelpdesk@fda.hhs.gov automatically creates a new account for each “from” email address. If you have previously communicated with esghelpdesk@fda.hhs.gov then your account already exists in the system and you do not need to send another email to create account. Follow steps 6 - 8 to access your tickets via https://esghelpdesk.fda.gov.
  4. If you have not communicated with esghelpdesk@fda.hhs.gov then you will need to submit your first ticket to esghelpdesk@fda.hhs.gov. A new account would be created for the user once this email is received. You will then follow steps 5 - 7 to access your tickets via https://esghelpdesk.fda.gov.
  5. ESG users must acquire a password before they can log into web interface. A User can obtain password by clicking on the “Forgot Password” link in the lower right hand corner of the website’s login box:

login

  1. On “Password Help” screen please input your email and click the “Submit” button. You will receive your temporary password from esghelpdesk@fda.hhs.gov:

submit button

  1. After obtaining your password, ESG recommends changing your password.
    • Click on the “Profile” icon in the top ribbon
    • Enter a new password in the “Password” field
    • Re-enter the new password in the “Confirm Password” field
    • Click the “Save” button

change password

 

For more questions on the Gateway ticketing system, please send questions to esghelpdesk@fda.hhs.gov.

Contact Us

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

 

Page Last Updated: 06/19/2018
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