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  1. Create an ESG Account

Setting up a WebTrader Account Checklist

Checklist for Setting up a WebTrader Account with the FDA Electronic Submissions Gateway (ESG)

For assistance with ESG related items, please contact [email protected].

Request a WebTrader account

1. Send an email to [email protected] requesting a WebTrader test account. Please make the subject of the email “New WebTrader Test Account Registration”. Provide the following information:

Preparatory activities
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 from a CA or create one using our certificate generation tool. Click here for more information on certificates.  

4. 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.
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.
6. Read the User Guide and tutorials on the FDA ESG web site. Review WebTrader System Requirements.
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.

Pre-Production Setup:

  1. Go to https://esgtest.fda.gov/login
  2. Insert your current WebTrader Pre-Production User ID and Password
  3. Download the required Installer
  4. Please click here for the new WebTrader tutorial
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 test submission:

  1. If your company does NOT currently have a Production WebTrader account and you intend to send to FDA: Send a guidance compliant test submission to the appropriate FDA center with appropriate submission type. Each FDA Center has published guidance on the preparation of electronic submissions. Click here to view specific Center web site for information about guidance compliant submissions.
  2. If your company does have a Production WebTrader account and you intend to send to FDA: To ensure your WebTrader account works properly, send a test submission to the Center labeled “GWTEST” and the Submission Type labeled ”ConnectTest”. After you receive an Acknowledgement, please send an email to [email protected] with the Acknowledgement’s Core ID.
  3. If you intend to send to HC (Health Canada): For all new accounts send a TEXT file to the HC center using your (WebTrader / AS2) test account. Note that the guidance compliance test is NOT required for this center. Text file contents are not reviewed. After you receive  an Acknowledgement, please send an email to [email protected] with the Acknowledgement’s Core ID.
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.
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 [email protected]

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