Regulatory Open Forum

 View Only

  • 1.  FDA CDRH ESG WebTrader portal help

    Posted 14-Sep-2019 16:01
    HI - has anyone set up their electronic submission gateway portal recently? I've been going back and forth on emails with the FDA on this and not getting much guidance. I'm at the point of making the test submission. I really only need the portal for MDRs, but it seems that I need to send a device submission for the test. Do I download the eSubmitter tool if I'm only using the portal for MDRs?

    ------------------------------
    Kate Ashley
    Quality and Regulatory Affairs Manager
    ThermiGen, LLC (A Celling Biodevices Company)
    Irving, TX
    United States
    ------------------------------


  • 2.  RE: FDA CDRH ESG WebTrader portal help

    Posted 14-Sep-2019 17:16
    The eSubmitter tool is an easy way to generate MDRs, so probably​ you do want to install it. The other option would be your own software to generate the MDR and submit it via an HL7 interface (AS2 Gateway-to-Gateway).

    Your test submission can be an MDR (with made-up test data in each field). The eSubmitter tool can be used for other kinds of submissions, too, but its MDR module may be all you need.

    ------------------------------
    Anne LeBlanc
    Manager, Regulatory Affairs
    United States
    ------------------------------

    Original Message


  • 3.  RE: FDA CDRH ESG WebTrader portal help

    Posted 15-Sep-2019 07:25
    I set mine up about a year ago and remember it taking three months from start to finish because FDA wouldn't reply with a status.

    If I remember correctly, you can send just about any pdf file for the test submission, but if you are going to be submitting manufacturer or importer MDRs, you will need to use the eSubmitter tool.

    What you transmit through the Gateway are the data that populate the fields in the pdf, not the actual pdf itself. For MDRs' the pdf file generates by eSubmitter is like an "afterthought." It gets put into your AppData/Roaming folder with a generic name, so if you want to show someone what you plan to submit, you have to first find the file and then save it, because the next MDR you create will overwrite that pdf file.


    ------------------------------
    Jean Bigoney PhD, RAC, CQE
    Regulatory Affairs Specialist
    Morrisville NC
    United States
    ------------------------------

    Original Message


  • 4.  RE: FDA CDRH ESG WebTrader portal help

    Posted 16-Sep-2019 02:51

    ​Yes, you have to use eSubmitter. And you will receive 3 acknowledge-messages from ESG / CDRH. You have to download the 3 messages and store them for any review. Furthermore you have to verify that in the third message you read "passed" and not "failed". If you have the latter you have to verify the fault, correct it and send the report again. Good luck!



    ------------------------------
    Oscar Banz
    Head of QM & RA
    Grenchen
    Switzerland
    ------------------------------

    Original Message


  • 5.  RE: FDA CDRH ESG WebTrader portal help

    Posted 16-Sep-2019 10:05
    In our software system, InfoMed, a complaint handling and adverse events reporting system, there is a built-in routine that creates an XML file that directly uploads to the CDRH's eMDR database...you don't have to use their eSubmitter tool interactively. You still need to set up an account with them to access the database, and yes, you need to go thru the process of setting up a test account and then qualifying for a production account. Our Tech Support team offers a service package to facilitate this from the beginning to the end.

    ------------------------------
    Barry Ashar
    President
    Makromed, Inc.
    Salem NH
    United States
    ------------------------------

    Original Message


  • 6.  RE: FDA CDRH ESG WebTrader portal help

    This message was posted by a user wishing to remain anonymous
    Posted 17-Sep-2019 11:24
    This message was posted by a user wishing to remain anonymous

    Another way is to use your old files to pass the test account. For example, depending on which center you are sending, choose the simplest file or the file you have used before from the drop list: eDMF, eCTD, adverse event, promotional materials...
    Once you passed the test submission, you can use any function of it.
    Original Message


  • 7.  RE: FDA CDRH ESG WebTrader portal help

    Posted 19-Sep-2019 05:31
    Thank you all. This was helpful. I was able to make the test submission and received the 3 acknowledge messages.

    ------------------------------
    Kate Ashley
    Quality and Regulatory Affairs Manager
    ThermiGen, LLC (A Celling Biodevices Company)
    Irving TX
    United States
    ------------------------------

    Original Message


Related Content