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  • 1.  Electronic Submission Gateway (ESG) issue

    Posted 06-Oct-2017 12:44
    Hi RAPS community, 

    I wanted to see if anyone is having a similar issue I am having with the FDA's new Electronic Submission Gateway (ESG). I've downloaded the 64-bit application and logged into the submit a Medical Device Report but when I attempted to submit the report I received an error message that reads "The User Services application was not detected," and tells me to download the application. I have inserted a snapshot of the page below.

    I've been working with the ESG help desk but myself any my IT department can not get around this error message. We have opened up all connections to IP addresses/ports, lowered firewalls for my computer, used different bowers, and un-installed and re-installed the application multiple times to no success. 

    I can't be the only person that has experienced this or similar issues and I wanted to see if the community knows a solution to this issue. 

    Thank you,
    Ryan  The User Services application was not detected.

    ------------------------------
    Ryan Hoffmeister
    Regulatory Affairs Analyst

    ------------------------------


  • 2.  RE: Electronic Submission Gateway (ESG) issue

    Posted 06-Oct-2017 14:20
    Hi Ryan,

    I've not had any issues with the new ESG (knock very loudly and often on wood).  I used the 32-bit installer when I downloaded the application.  Have you tried that one?

    Wishing you the very best of luck with this and hope you find a workable solution!
    Mary

    ------------------------------
    Mary Waters
    Hartmann Willner
    Washington DC
    United States
    mlwaters@hw-fda.com
    ------------------------------

    Original Message


  • 3.  RE: Electronic Submission Gateway (ESG) issue

    Posted 06-Oct-2017 14:42
    Hi Mary, 

    Unfortunately that didn't work. We're still getting the same error message.

    Ryan

    ------------------------------
    Ryan Hoffmeister
    Regulatory Affairs Analyst
    ------------------------------

    Original Message


  • 4.  RE: Electronic Submission Gateway (ESG) issue

    Posted 06-Oct-2017 14:54
    Ryan,

    Please try the following.

    To Resolve the Error:

    1. Uninstall the WebTrader Client. Be sure to select the option to delete data during the uninstallation.
    2. Install Client as Current User.
    3. Go to Internet Options in Internet Explorer.
    4. Select Trusted Sites.
    5. Add https://esgtest.fda.gov & https://localhost:8443 to the Trusted Sites.
    6. Click OK.
    7. Login to your Test account. Click Trust Connection under the Alerts section, if applicable.

    Thank you.

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    REGULATORY DOCTOR
    Phone (Toll-Free): 1-(800) 321-8567

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.





    Original Message


  • 5.  RE: Electronic Submission Gateway (ESG) issue

    Posted 06-Oct-2017 15:09
    Ryan,

    Please also add https://esg.fda.gov

    D



    Original Message


  • 6.  RE: Electronic Submission Gateway (ESG) issue

    Posted 06-Oct-2017 16:13
    Hi David,

    We have done this before to no success.

    We have used internet explorer, firefox and google chrome, we are using Windows 10 version 61.0.3163.100. We have configured our settings to connect to IP 150.148.128.23 on port 3080, set http://localhost:8443 as a trusted site, and we are also using a NAT server.

     If there are any other options to my situation I would really appreciate to hear them.
    Thank you,
    Ryan

    ------------------------------
    Ryan Hoffmeister
    Regulatory Affairs Analyst
    ------------------------------

    Original Message


  • 7.  RE: Electronic Submission Gateway (ESG) issue

    Posted 04-Apr-2023 09:45

    Yes I had a similar issue.  I reached out the FDA Help desk and they gave me some ideas (See below).  I found that running Edge in "Internet Explorer" mode helped.  I could not get it to work in Chrome or Firefox (?!?!).  Also, I had to add the trusted sites as described below.  I wish this portal was more like the new Customer Collaboration Portal.  The ESG system has always been very difficult to get working. 

    Per the help desk:
    "Please use Edge in IE mode.

    1. Select Alerts from the left navigation menu.
    2. Look for the option to Trust Connection under Actions.
    3. Click Trust Connection if it is a listed action.
    4. The WebTrader User Services screen will appear with directions that are specific to your web browser. To continue, click Yes, proceed:
    5. Select the Advanced button.
    6. Select the Add Exception button:
    7. Next, select the Confirm Security Exception button



    If this does not work,

    1. Uninstall the WebTrader Client. Be sure to select the option to delete data during the uninstallation.
    2. Install the newly downloaded Client as All Users in a newly created folder on the C Drive(C:\WebTrader).
    3. Go to Internet Options in Internet Explorer.
    4. Select Trusted Sites.
    5. Add https://esgtest.fda.gov/ & https://esg.fda.gov/ & https://localhost:8443/ to the Trusted Sites.
    6. Click OK.
    7. Login to your Test account. Click Trust Connection under the Alerts section, if applicable.



    1. From the Tools menu, select Internet Options.
    2. Select the Security tab.
    3. Clear the Enable Protected Mode option.
    4. Set the Security level for this zone to Medium-high or lower.
    5. Open Custom Level and make sure the following options are enabled:
    a. File Download
    b. Active Scripting
    6. Click OK.
    7. Close and reopen the browser.



    Also change these settings:
    1. Select the Internet zone and click on the Custom level button.
    2. In Security Settings, scroll down to Downloads.
    3. Set File download to Enable.
    4. Scroll down a bit more and you will see Miscellaneous. Here make sure that Launching applications and unsafe files is set to Prompt (recommended).
    5. Click Apply/OK and Exit.
    6. Then ensure that file downloads are allowed for the zone for esgtest.fda.gov & https://esg.fda.gov/.



    ------------------------------
    Alyssa Roelli
    Senior Regulatory Projects Manager
    Milwaukee WI
    United States
    ------------------------------

    Original Message


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