For Industry
User Guide
FDA Electronic Submissions Gateway (ESG)
January 16, 2013
Table of Contents
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
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 G: AS2 Header Attributes
Appendix H: Sample Letters of Non-Repudiation Agreement
Appendix I: EDIFACT Message Structure
Appendix J: Digital Signatures
Appendix L: Installing Java Runtime Environment 1.7
