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Electronic Submissions Gateway (ESG) Load Test

The Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG) allows Trading Partners the option to send a Load Test as part of WebTrader registration. The FDA ESG requires that Trading Partners send a Load Test as part of AS2 registration. The following sections outline the recommended types of Load Tests by protocol and Center. While WebTrader registration approval does not require a Load Test, it may be useful for Trading Partners to validate their organization’s ability to send large files to ESG.

Load Test submissions do not need to be guidance compliant (the submission will not be reviewed by FDA), but should be representative of the file types you will be submitting in a typical submission (i.e., a mixture of PDF, text files, MS Word files, etc.).

WebTrader

The Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG) recommends the following Load Test submission sizes based on Center / Program:

  • 2 GB Load Test:   CDER, CBER and CTP
  • 1 GB Load Test:   GDUFA, CVM, OC,OCPP, AERS, CFSAN and HC

If you foresee sending larger than a 2 GB submission to the FDA through ESG, then we strongly recommend that you submit a 7.5 GB Load Test submission.

AS2

The Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG) requires the following Load Test submission sizes based on the type of submissions you plan to send to the Gateway:

  1. If you plan to send large files (1GB or more), please submit a 2 GB single file submission
  2. If you plan to many small files:
    1. Please send 1 batch mulit-file submission, containing 50 files and
    2. Please send 1 batch mulit-file submission, containing 20 files

If you foresee sending larger than a 2 GB submission to the FDA through ESG, then we strongly recommend that you submit a 7.5 GB Load Test submission.