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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

Attention WebTrader submitters!

The FDA ESG has implemented new password requirements to enhance system security. The new requirements for password are the following:

  1. Contain at least one special character. The following special characters are allowed:
    1. ~!@#$%^&*()-=[]{}\|;:",.<>?
  2. Must be changed every 90 days and cannot be the same as the last 8 passwords.
  3. Contain at least one numerical value.
  4. Contain at least one upper case and one lower case character.
  5. At least 8 characters long, without blank spaces.

For any questions/concerns relating to the WebTrader password policy, please contact ESGHelpDesk@fda.hhs.gov.

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