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

 Attention multi-file or folder-based submitters!

 

Please be advised that ESG has implemented an enhancement to process large submissions. Prior to this enhancement ESG was not able to process multi-file or folder-based submissions containing a single file larger than 8GB.  This enhancement removes the file size limitation.

 

FAQs:

Q1: Is there any file size limitation after this enhancement?

Answer: No. However, the ESG team was only able to test with folders containing up to 35GB single file.

Q2: Can I test with folder-based submissions with a single file larger than 35GB?

Answer: Yes. Please contact ESG Help Desk (esghelpdesk@fda.hhs.gov) to coordinate testing.

Contact Us

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

 

Page Last Updated: 11/30/2018
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