Checklist for Setting up a WebTrader Account for the FDA Electronic Submissions Gateway (ESG)
For assistance with ESG related items, please contact ESGHelpDesk@fda.hhs.gov.
|1. Prepare an electronic Letter of Non-Repudiation. The ESG Account Managements Portal allows you to upload an electronic Letter of Non-Repudiation. A hard copy of the Non-Repudiation Letter must still be mailed to the FDA.
Click here for more information on Non-Repudiation Letters.
Click here for additional steps pertaining to CROs, US Agents and Consultants.
|2. The ESG Account Management Portal provides the option to generate a free personal digital certificate during registration or to upload one you acquired from a CA. Click here for more information on certificates.
Click here for more information on certificates.
|3. Optional: Prepare a guidance compliant test submission. Each FDA Center has published guidance on the preparation of electronic submissions. Refer to the specific center web site for information about guidance compliant submissions.|
|4. Optional: Prepare a load test submission. Each FDA Center and protocol have different load test requirements. Refer to the load test web site for information about load test submissions.|
|5. Read the following materials:|
|Register Your WebTrader Account|
|6. Access the FDA ESG Account Management Portal website at https://esgportal.fda.gov/. Then, select the
|7. Receive the account confirmation email.|
|Setup Your Machine|
|8. Set up your ESG WebTrader Test (Pre-Production) environment:|
|Send Test Submissions|
|9. Send a test submission via WebTrader:
|10. Optional: Send a Load Test submission with the Submission Type selected as "SizeTest" and to the center labeled "GWTEST". Refer to the load test website for information about load test submissions.|
|The FDA will review your guidance compliant test submission, which may take up to 1 week. Once it is approved, your account will be automatically migrated to the ESG Production environment.|
|Production Account Approval|
|11. Once the center approves your guidance compliant submission, the FDA ESG team will migrate your account to production and notify you.|
|12. Now, access the ESG WebTrader Production application: https://esg.fda.gov/. Provide your ESG WebTrader account credentials (User ID and Password) from step 6 above.|
|Log in to your ESG WebTrader production account with the same user ID and password you created when you registered for your test account (step 7 above).|
|You are now ready to send electronic submissions to FDA using the ESG WebTrader application.|
For assistance with the registration or testing process, contact ESGHelpDesk@fda.hhs.gov.