FDA Electronic Submissions Gateway (ESG) Tutorial

Sending a web-based test submission and viewing its receipt

Sending a web-based test submission

Before sending a web-based test submission, ensure that the test account approval has been received from FDA.

Access https://esg.fda.gov to launch the FDA Electronic Submissions Gateway WebTrader.

The Login page is displayed:

webtrader_login.gif

If this page does not show the test environment warning, exit the browser and contact the FDA Electronic Submissions Gateway Administrator at esgprep@fda.hhs.gov to request access to the test environment.

  1. Log in to the Gateway with the User ID and password you created with the FDA Electronic Submissions Gateway Registration Wizard (step 7).

If you have forgotten your password , contact the FDA ESG Administrator at esgprep@fda.hhs.gov.

When you log in, the My FDA submissions page displays any messages you have sent to the FDA:

webtrader_Documents_in_Inbox.gif

  1. Click the WebTrader menu and select Send document.

webtrader_Documents_in_Inbox_webtrader_menu.gif

  1. On the Send document page :

    • Select an FDA center  from the Center drop-down options. You can select CBER, CDER, CDRH, CFSAN, CVM, GWTEST, or OOPD.

    • Enter or select the path of the test submission file(s) using the Browse... button in the Path field. Use the Choose File window to navigate to the location where the file for submission is saved. Select the file and click Open. The Root directory field is automatically populated.

    • Select a test submission type from the drop-down options for the Submission type field.

    • In the New file field, enter the path to a signing certificate, or select it using the Browse... button. Your certificate must have a file extension of .pfx or .p12. All submissions require a certificate for digital verification and encryption.

    2. Webtrader Send document page

  2. When this page has been completely populated, it should look similar to this:

    3. Completed Send document page

  3. Click Send. Enter your security certificate password.

    4. WebTrader Enter password dialog

  4. The Upload Progress dialog box is displayed. The dialog box will say "Done" when a file has been successfully uploaded.

Document upload status

Accessing the Test Submission Receipt and Acknowledgment

When the Gateway successfully receives your test submission, it will send a receipt email called a Message Delivery Notification (MDN) to your account. When your FDA center successfully receives your submission from the Gateway, the Gateway will send you an acknowledgment. You can access both the MDN and the acknowledgment in My FDA submissions.

  1. Click on the WebTrader menu and select My submissions.

    2. Checking the test account inbox

  2. The links to the MDN and the acknowledgment are in the Status column.

    3. Checking a test submission receipt

  3. Click on the Receipt link for information about the MDN. Click View document to see the actual MDN.

  4. Click on the Acknowledgment link for information about the acknowledgment.

For more information about MDNs and acknowledgments, see Section 4.8, Tracking Submissions in the user guide.

If you do not receive a receipt, contact the FDA ESG testing representative at esgprep@fda.hhs.gov.

Once the FDA has successfully received a test submission from your account, you can request an ESG Production account.