Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

        Electronic Submissions Gateway

Policies/Guidance

                        
                Links to Center-Specific Submission Preparation Guidelines
          Important Information About Digital/Electronic Signatures
          Important Email Policy
          Outage Notification and Disruption Policy Home
          For Industry
          Electronic Submissions Gateway
          Policies/GuidanceElectronic Submissions Gateway Policies/Guidance
  	
        Share
    Post
    Linkedin

    Email
    PrintWhat is ESG?
The Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG) is an Agency-wide solution for accepting electronic regulatory submissions. The FDA ESG is a highly scalable, easily available, high performance and secure exchange point for FDA and its partners to transact a variety of documents and submissions over industry-standard protocols. The FDA ESG enables the secure submission of premarket and postmarket regulatory information for review. The FDA ESG enables the FDA to process regulatory information automatically, functioning as a single point of entry for receiving and processing all electronic submissions in a highly secure environment.  The FDA ESG complies with secure Hypertext Transfer Protocol (HTTP) messaging standards and uses digital certificates for secure communication. The electronic submission process encompasses the receipt, acknowledgment of receipt (to the sender), routing and notification (to a receiving Center or Office) of the delivery of an electronic submission.
FDA ESG provides two methods, WebTrader and AS2, for making submissions to FDA.  FDA ESG has been in production since 2006 and is used by 100s of users to send 1000s of submissions every day.
WebTrader (WT): A web portal designed for low volume submitters. WT allows users to login, digitally sign and submissions, and view responses through a simple web interface.
    AS2: A system-to-System connection to exchange submissions with FDA. AS2 requires a Gateway software implementation on submitters end.
Where do Submissions Go?
The FDA ESG is the central receipt point for sending information electronically to the FDA. Within that context, the FDA ESG is a conduit, or "highway", along which submissions travel to reach their final destination. The FDA ESG does not open or review submissions, but automatically routes them to the proper FDA Center or Office.  Industry Partners can send a receive documents from the Gateway via a web interface or server to server communications.
Contact Us
**For ESG Related Questions**
Email: **ESGHelpDesk@fda.hhs.gov**

                                                                                  Content current as of:
      12/07/2016Policies/Guidance                
                          

                        Links to Center-Specific Submission Preparation Guidelines
          Important Information About Digital/Electronic Signatures
          Important Email Policy
          Outage Notification and Disruption Policy
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop