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  1. Create an ESG Account

Setting up an AS2 Account Checklist

Checklist for Setting up an AS2 Account with the FDA Electronic Submissions Gateway (ESG)

For assistance with ESG related items, please contact ESGHelpDesk@fda.hhs.gov.

Request an AS2 account

1. Send an email to ESGHelpDesk@fda.hhs.gov requesting an AS2 test account. Please make the subject of the email “New AS2 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. 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. Prepare a load test submission.  Each FDA Center may 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.
Register Your Test Account
Wait for email with information on how to register online for an AS2 test account.  (The reply email from Step 1)
7. Review the steps to Register for an AS2 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 AS2 accounts, we recommend appending the user's initials to your company name.
Wait for the AS2 test account activation email. Account activation may take up to 48 hours.
Setup your machine for AS2 usage
8. After you have received the activation email, configure your firewall and ports and install the FDA public Test certificate (activation email will contain the details). The FDA Gateway does not allow SSL 3.0.
Send Test Submissions
9. Send a guidance compliant test submission to the appropriate center with appropriate submission type. See Item 4 above for more information.
10. Send a Load Test submission to Routing ID “GWTEST_7GB” or Center as GWTEST and submission type as SizeTest. The type of test submission will be based on the type of files you plan to send to the Gateway. 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 your test submissions have been approved, the ESG HelpDesk will send instructions on how to Register for an AS2 Production account.
Wait for the AS2 Production account activation email. Account activation may take up to 48 hours.
12. After you have received the activation email, configure your firewall and ports and install the FDA public Production certificate (activation email will contain the details).
You are now ready to send electronic submissions to FDA using the ESG system.

For assistance with ESG related items, please contact ESGHelpDesk@fda.hhs.gov.