The FDA Electronic Submissions Gateway (ESG) is the central transmission point for sending information electronically to FDA.
Registering to use the FDA ESG involves a sequence of steps to be conducted for all submitters and types of submissions. It is best to start well in advance of when you plan to make a submission.
The account creation process includes a testing phase designed to ensure that the FDA ESG can successfully receive your electronic submission and that the electronic submission is prepared according to published guidelines. The testing phase is done through the FDA ESG test system. Once the submitter’s test submission has passed the testing phase, an account will be set up to allow submissions through the FDA ESG production system.
All relevant information, including detailed descriptions of the steps and contact information for requests and assistance, can be found on the FDA ESG website.
Tip: Allow plenty of time to complete the multi-step account creation process and become familiar with the ESG interface.
