FDA Electronic Submissions Gateway (ESG) User Guide ... - ICON plc

travel to reach their final destination. It does not open or review submissions; it merely routesthem to the proper destination.The FDA ESG uses a software application certified to comply with secure messaging standards.The screen graphics provided in the FDA ESG Web Interface sections of this User Guide arefrom the application.1.1 ObjectiveThe objective of this User Guide is to provide industry participants with information andguidance on how to prepare and send documents through the FDA ESG. See Table 2: ElectronicSubmissions Supported by the FDA ESG for a list of submissions that the FDA ESG will accept.This document provides a high-level description of the electronic submission process via theFDA ESG.2. Overview of the Registration ProcessRegistering to use the FDA ESG involves a sequence of steps that are to be conducted for allsubmitters and types of submissions. The first steps in the process are designed to ensure that theFDA ESG can successfully receive electronic submissions and that the electronic submissionsare prepared according to published guidelines. The testing phase is done using the FDA ESGtest system. Once the sender has passed the testing phase, an account will be set up allowing thesubmissions to be sent to the FDA ESG Production System.The following diagram illustrates the steps in the process. The remaining sub-sections in Section2 explain each of the steps in turn.