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  1. FDA eSubmitter

Getting Started with eSubmitter

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