Submit to FDA Gateway

If your submission has a status of “Ready to Submit” and you have added the FDA Submissions Gateway to your account, a green arrow will appear in the “Submit to FDA Gateway” column (Red Box).

If you click “OK”, the file will be submitted to the FDA via the ESG gateway. All receipts, acknowledgements and errors will be shown on the submission page and notifications will be sent via email to the user who performed the submission.

In the event that an Error Response is received, and a Manual Override Request is grated, a copy of the FDA’s email stating that the Manual Override Request had been granted can be uploaded to the Submission Record. Doing so will change the Latest FDA Response Status from “Error Received” to “Manual Override Confirmed” and a new Status Icon/Statue Image with be displayed.