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  1. FDA eSubmitter

Mac Install Instructions


Yes, we can help. Unfortunately, we do not have a Mac to test from but we have been able to put together some basic steps based on industry feedback of users that have successfully installed eSubmitter on a Mac.

Step 1: Uninstall other Java runtimes.

If you have any other Java's currently installed, we recommend you first uninstall them (using AppCleaner or AppDelete) and then restart your computer. The problem with having multiple Java's installed is that the system may still attempt to use an incompatible Java with eSubmitter, even if a compatible one is available.

Step 2: Install the correct version of Java from Java’s website. See link below:
https://java.com/en/download/help/mac_install.xml disclaimer icon

Step 3: Install eSubmitter.

  • We have an installer that installs the eSubmitter application using the Java runtime. It isn't provided on the FDA website but can be found at the following link:
  • Run the installer. When the installer provides the option of installing to a local workstation or network drive, select "network drive". The local workstation option assumes a Windows based install, while the network drive option better suits a Mac and we will select a local drive anyway.
  • When asked where to install select a local folder you have access to. I was told some install under "/Users/<your_user_name>/Applications/eSub". I would follow your standard practice used when installing other applications
  • Next we need to manually setup a few folders to hold the eSubmitter Data, Output, Temp, and Package files. The Data file should already be created for you in the same location where you installed the application. These folders can be located anywhere (even a network drive). Please create the following additional folders: output, temp, and package). They can be located alongside the "data" folder or you can create them in another location. Just make sure to remember where because we will need that information in a following step.

The purpose of each folder is as follows:

  • Data: Where the files you create in eSubmitter are stored. They hold your responses and can be reopened in eSubmitter at any time
  • Output and Temp: Files created during processing with in eSubmitter (report file, missing data file, temp file generated as part the final packaging process)
  • Package: This is where the final submission files will be located that you will then transmit to FDA

Step 4: Run eSubmitter.

  • Execute the eSubmitter application. Each time opened it will check for updates and download them using your internet connection. We generally deploy updates once a month. If you have issues and the application won't open, it is probably due to a Java runtime incompatibility issue.
  • Once opened, you should get a message about invalid folders since eSubmitter is not currently configured to locate the folders we just created. Close the dialog. Select the Preferences option within the File menu, and click the File Locations tab. From this screen, set the references to point to the folders you manually generated. Once completed, close and restart eSubmitter. You should no longer receive the dialog about the folders. Now fill out the registration and begin the process of generating submission.

FYI, the registration process may not be able to access your email account. If it can't, just send an email manually to this account with your registration information.

Let us know if you have any questions.


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