User Guide for FDA Electronic Submissions Gateway (ESG)

January 16, 2013

By Global Compliance Seminar (LinkedIn Twitter)

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 Set Up a Production Account
2.5 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

Electronic Submissions Gateway User Guide

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Last Date Updated: January 2, 2015

FDA ESG User Guide
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