FDA ESG (Electronic Submission Gateway)

The FDA ESG is the central transmission point for sending information electronically to the FDA. The  FDA ESG is a conduit, or "highway", along which submissions travel to reach their final destination. It does not open or review submissions; it merely routes them to the proper destination. A single point of entry for receiving and processing all electronic submissions in a highly secure environment.Automating current electronic processes such as the electronic acknowledgment of submissions.Supporting the electronic Common Technical Document (eCTD).

The electronic submission process is defined as the receipt, acknowledgment, routing, and notification to a receiving Center of the receipt of an electronic submission. Each of these terms denotes a step in the process of electronic submission delivery, and together, these steps comprise the whole scope of electronic submission delivery.

"Receipt" means transfer of a submission from a sender’s system to a temporary storage area in the FDA ESG."Acknowledgment" to the sender that the submission was sent from the sender’s system and received by the Gateway."Routing" refers to delivering a submission to a Center-level storage area and initiating a load process to place a submission into a Center receiving system."Notification" of a submission’s arrival is made to those individuals responsible for the Center’s receiving system.