Checklist for Setting up a WebTrader Account with the FDA Electronic Submissions Gateway (ESG)
For assistance with ESG related items, please contact ESGHelpDesk@fda.hhs.gov.
|Request a WebTrader account|
1. Send an email to ESGHelpDesk@fda.hhs.gov requesting a WebTrader test account. Please make the subject of the email “New WebTrader Test Account Registration”. Provide the following information:
|2. Send a hard copy Letter of Non-Repudiation to the FDA.|
Click here for more information on Non-Repudiation Letters.
Click here for additional steps pertaining to CROs, US Agents and Consultants.
|3. Obtain a personal digital certificate. Click here for more information on certificates.|
|4. 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.|
|5. 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. |
Note: You should not perform step 5 if you plan to only use the WebTrader Hosted Solution (WTHS).
|6. Read the User Guide and tutorials on the FDA ESG web site. Review WebTrader System Requirements unless you plan to make submissions via WTHS only.|
|Register Your Test Account|
|Wait for email with information on how to register online for a WebTrader test account. (The reply email from Step 1)|
|7. Review the steps to Register for a WebTrader test account in the reply email (generated from step 1). You will need the public key for your personal digital certificate to complete this step.|
Note: The Primary Contact must be a real person; the "Company Name" is actually an account name and must be unique throughout the entire ESG test system. In the event that your company has multiple WebTrader accounts, we recommend appending the user's initials to your company name.
|Wait for the WebTrader test account activation email. Account activation may take up to 48 hours.|
|Setup your machine/PC for ESG|
|8. Activation email received.|
|a. Install JRE and JCE. JRE and JCE Installation Instructions|
Note: You do not need to perform step 8a if you plan to only use the WebTrader Hosted Solution (WTHS).
|b. Configure your firewall (activation email will contain the details)|
Note: You do not need to perform step 8b if you plan to only use the WebTrader Hosted Solution (WTHS).
|Send Test Submissions|
|Log in to your ESG WebTrader test account (same URL to Register for a test account) with the user ID and password you created when you registered for your test account (step 6 above).|
|9. Send a guidance compliant test submission to the appropriate center with appropriate submission type. See Item 4 above for more information.|
|10. Optional: Send a Load Test to the center labeled GWTEST and the Submission Type labeled SizeTest. Refer to the load test web site for information about load test submissions.|
Note: You should not perform step 10 if you plan to only use the WebTrader Hosted Solution (WTHS).
|The FDA will review your guidance compliant test submission, which may take up to 1 week. You will receive an email from ESG Helpdesk regarding submission status.|
|Production Account Approval|
|11. Once you have sent a successful guidance compliant submission, your account will be migrated to production. You will receive an email from ESG Helpdesk with production account confirmation and production URL.|
|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 system.|
For assistance with the registration or testing process, contact ESGHelpDesk@fda.hhs.gov.