• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

For Industry

  • Print
  • Share
  • E-mail

User Guide

FDA Electronic Submissions Gateway (ESG)

January 16, 2013

 

Table of Contents

1 Introduction
   1.1 Objective

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 Apply for a Production System Account
     2.5 Production System Account
     2.6 Send Submissions to the Production System

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 Detemine Submission Method 
     3.6 Connection Requirements
     3.7 Help and Information

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 Sending Large (> 7.5 GB) Submissions
     4.8 Tracking Submissions
           4.8.1 The Submission Process
           4.8.2 Message Delivery Notifications (MDNs) and Acknowledgements
           4.8.3 Message IDs and Core IDs
           4.8.4 Accessing MDNs and Acknowledgements

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

6 References/Resources

Appendix A: Troubleshooting the FDA ESG Web Interface

Appendix B: Creating tar Files and Compressing Files for Submission

Appendix C: Digital Certificates

Appendix D: Installing Java Runtime Environment

Appendix E: Glossary of Terms

Appendix F: Acronyms

Appendix G: AS2 Header Attributes

Appendix H: Sample Letters of Non-Repudiation Agreement

Appendix I: EDIFACT Message Structure

Appendix J: Digital Signatures

Appendix K: AS2 Routing IDs