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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

In this section: FDA eSubmitter

Getting Started with eSubmitter

Step 1. Read the below information before starting the registration process

Guidance for Industry (GFI) #108 - How to register with the CVM Electronic Submission System (ESS)
CVM Recommended File Specifications for eSubmitter
FDA ESG User Guide

Step 2. Decide on your submission method (FDA ESG User Guide)

Step 3. Start the registration process

Follow the FDA ESG and CVM ESS registration diagram flow and the FDA ESG Web Trader Checklist step-by-step
Save time by completing the FDA ESG and CVM ESS registration processes at the same time
Simplify the registration process by using the sample Registration Letter in GFI #108 and online sample Non-Repudiation Agreement Letter
Allow at least 30 days to complete the registration process

Step 4. Download the CVM eSubmitter tool*

*This link will download the CVM eSubmitter Tool. If you need to submit to a Center other than CVM you will need to download the FDA eSubmitter tool.

Compatible with Windows XP, Windows 7, Windows 8 and Windows 10. You must use Adobe V or later.

Step 5. Learn how to use your eSubmitter by viewing the CVM eSubmitter Quick Guide

Need Help?

Email us at cvmesubmitter@fda.hhs.gov

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