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:

                About ESG

About ESG

                        User Guide
          ESG Account Management Portal User Guide
          Submission Statistics
          Impact of the Gateway
          Center Submission Types
          Submission Acknowledgements
          ESG Submission Process
          Planned Maintenance and Status History
          Submission Times Home
          For Industry
          Electronic Submissions Gateway
          About ESG
          User GuideAbout ESG User Guide
  
  	
    Share
    Post
    Linkedin

    Email
    PrintTable of Contents


CHAPTER 1 – INTRODUCTION

1.1 Objective

CHAPTER 2 – OVERVIEW OF THE REGISTRATION PROCESS

2.1 Apply for a Test Account
	2.2 Test Account Setup and Approval
	2.3 Send a Test Submission
	2.4 Set Up a Production Account
	2.5 Send Submissions to the Production System

CHAPTER 3 – PREPARATORY ACTIVITIES

3.1 Submit Letter of Non-Repudiation Agreement
	3.2 Obtain Digital Certificate
	3.3 Understand Submission Guidelines
	3.4 Naming Conventions
	3.5 Determine Submission Method
	3.6 Connection Requirements
	3.7 Help and Information

CHAPTER 4 – FDA ESG WEB INTERFACE ELECTRONIC SUBMISSIONS

4.1 Apply for a Test Account
	4.2 Test Account Setup and Approval
	4.3 Send a Test Submission
	4.4 Apply for a Production System Account
	4.5 Production System Account Setup and Approval
	4.6 Send Submissions to the Production System
	4.7 Tracking Submissions
	4.8 WebTrader French Language Translation

CHAPTER 5 – AS2 GATEWAY-TO-GATEWAY ELECTRONIC SUBMISSIONS

5.1 Apply for a Test Account
	5.2 Test Account Setup and Approval
	5.3 Send a Test Submission
	5.4 Apply for a Production System Account
	5.5 Production System Account Setup and Approval
	5.6 Send Submissions to the Production System
	5.7 Sending Large (> 7.5 GB) Submissions
	5.8 Common AS2 Errors

CHAPTER 6 – REFERENCES/RESOURCES

6 References/Resources

APPENDICES

Appendix A: Troubleshooting the FDA ESG Web Interface
	Appendix B: Creating tar Files and Compressing Files for Submission
	Appendix C: Digital Certificates
	Appendix D: Glossary of Terms
	Appendix E: Acronyms
	Appendix F: AS2 Header Attributes
	Appendix G: Sample Letters of Non-Repudiation Agreement
	Appendix H: EDIFACT Message Structure
	Appendix I: Digital Signatures
	Appendix J: AS2 Routing IDs
	Appendix K: Sample Authorization Letter

Back to Top

                                                                                  Content current as of:
      03/01/2022About ESG

          
                        User Guide
          Account Management Portal User Guide
          Submission Statistics
          Impact of the Gateway
          Center Submission Types
          Submission Acknowledgements
          ESG Submission Process
          Planned Maintenance and Status History
          Submission Times
 
 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