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  1. FDA eSubmitter

Mac Install Instructions

The FDA eSubmitter application is now available as a universal standalone Java executable compatible with Intel-based and Apple Silicon (M-chip) Mac computers. This version utilizes a Java-dependent execution model, allowing macOS users to package and transmit submissions without the need for virtual machines or Windows-based workarounds.

Pre-Installation Requirements

  • Java Runtime Environment (JRE): Systems must have a compatible JRE installed. For optimal stability and to align with FDA standards, we recommend Amazon Corretto
  • Permissions: Ensure your user profile has full Read/Write access to the intended installation directory (e.g., /Applications/eSubProd).

Installation Steps
Step 1: Prepare the Java Runtime Environment (JRE): 

  1. Download Amazon Corretto: Download and install the macOS version of Amazon Corretto compatible with your processor type (x64 for Intel; aarch64 for Apple Silicon). See link below:
    o x64 for Intel: 

    https://corretto.aws/downloads/resources/8.492.09.2/amazon-corretto-8.492.09.2-macosx-x64.pkg

    o aarch64 for Apple Silicon: 

    https://corretto.aws/downloads/resources/8.492.09.2/amazon-corretto-8.492.09.2-macosx-aarch64.pkg

  2. Unpack Amazon Corretto: Locate the amazon-corretto-8 package. Double-click to unpack it, which will create the amazon-corretto-8.jdk folder.
  3. Install to System Library: Copy the amazon-corretto-8.jdk folder to the following system directory: /Library/Java/JavaVirtualMachines/

Step 2: Execute the eSubmitter Installer:

  1. Download the eSubmitter Installer: We have an installer that installs the eSubmitter application that is compatible with the Amazon Corretto Java runtime. It can be found at the following link: https://www.accessdata.fda.gov/esubmissions/ftparea/esubmitter/platforms/PureJava/Standalone/install.jar

  2. Bypass Developer Security Restrictions: Because eSubmitter is not downloaded from the Mac App Store, macOS Gatekeeper may block the initial launch. Follow these steps to authorize the installer:

    o Attempt to launch the installer: Double-click on install.jar. A warning dialogue will appear; click OK or Cancel to close it.

    o Open the Apple menu and select System Settings (or System Preferences).

    o Click Privacy & Security in the sidebar. o Scroll down to the Security block to find the message regarding the blocked "install.jar" file.

    o Click Open Anyway (this button remains active for approximately one hour after the failed launch attempt).

    o Type your Mac login password and press OK to confirm the exception.

  3. Follow the Wizard: Once the installer launches, click Next through the prompts until the installation is complete.
  4. Note Installation Path: You must remember the exact path where you installed the application, as you will need to edit a configuration file in that directory. The typical path structure is: /Users/<your_user_name>/Applications/eSubProd/

Step 3: Update the JExpress Configuration File
To ensure eSubmitter calls the correct JVM, you must manually update the properties file:

  1. Navigate to the JExpress folder within your installation directory: /Users/<user_name>/Applications/eSubProd/JExpress/.
  2. Open the eSubmitter.properties file for editing (e.g., using TextEdit).
  3. Locate the line beginning with “execFilename=”.
  4. Replace the entire line with the following path: execFilename=/Library/Java/JavaVirtualMachines/amazon-corretto-8.jdk/Contents/Home/bin/java.
  5. Save the file and close the editor.

Step 4: Manually Configure Application Folders
Because the macOS version does not utilize a Windows-based installer, you must manually create the following local directories if there are not there to ensure data persistence and successful packaging:

  • /Users/<user_name>/Applications/eSubProd/data (Stores your responses).
  • /Users/<user_name>/Applications/eSubProd/output (Stores packaged submissions).
  • /Users/<user_name>/Applications/eSubProd/temp (Stores temporary processing files).

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)
  • Output: This is where the final submission files will be located that you will then transmit to FDA.

Step 5: Finalize and Relaunch

  1. Open Application: Launch the application (e.g., eSubmitter.app).
  2. Resolve Folder Errors: Upon launch, you may receive an "Invalid Folder" message. Close the dialog and navigate to File > Preferences > File Locations.
  3. Bind Paths: Point the Data, Output, and Temporary fields to the folders you manually created in Step 4.
  4. Restart: Close the application entirely and relaunch it to initiate the JExpress auto-update sequence, which will ingest the latest monthly template refreshes and data store updates.

Technical Support Note:
If the application fails to launch after editing the eSubProd/JExpress/eSubmitter.properties file, verify that the path in execFilename exactly matches the location of your Corretto installation. If you receive "Permission Denied" errors when binding folders, ensure your user account has full Read/Write access to the eSubProd directory.

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.

Thanks,
eSubmitter Support

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