For Industry

User Guide

FDA Electronic Submissions Gateway (ESG)

 

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 Determine 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 Tracking Submissions
           4.7.1 The Submission Process
           4.7.2 Message Delivery Notifications (MDNs) and Acknowledgements
           4.7.3 Message IDs and Core IDs
           4.7.4 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

Appendix L: Sample Authorization Letter

 

 

Page Last Updated: 06/10/2016
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