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