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  • 1.  FDA Breakthrough Device Designation

    This message was posted by a user wishing to remain anonymous
    Posted 26-Feb-2021 08:54
    This message was posted by a user wishing to remain anonymous

    Does anyone have experience with FDA's Breakthrough Device designation?  FDA's guidance document is kind of light on what they want to see included for meeting the the second criterion.  Any thoughts would be most appreciated.

    Thanks!


  • 2.  RE: FDA Breakthrough Device Designation

    This message was posted by a user wishing to remain anonymous
    Posted 03-Mar-2021 08:59
    This message was posted by a user wishing to remain anonymous

    Hi,
    yes we have,
    we provided 2 elements under the second criterion 
    1. An evidence that our device is superior to similar devices ( with the same intended use) in our case the device is also providing a diagnosis of a life-threatening disease 
    2. We also demonstrate that there is no approved/cleared alternative. 

    We submited to FDA and were granted with the breakthroug designation. 
    I hope that helps.

    Original Message


  • 3.  RE: FDA Breakthrough Device Designation

    Posted 20-Mar-2021 18:00
    Yes, I've worked on several Breakthrough Device Designation Applications. I'm not sure I understand your questions exactly. You must meet at least 1 of the 4 possibilities for Criterion 2 but you may meet more than 1.  You must provide explanation as to how you meet that criterion.  If you'd like to talk a bit more about it, happy to have a conversation. Just direct message me.

    ------------------------------
    Isabella Schmitt, RAC
    Regulatory Affairs Consultant
    Houston TX
    United States
    ------------------------------

    Original Message


  • 4.  RE: FDA Breakthrough Device Designation

    Posted 21-Mar-2021 23:19
    Edited by Lawrence Maddela 21-Mar-2021 23:20
    Assuming your device is subject to either PMA, 510(k), or de novo, it can be designated as a Breakthrough Device as long as both of the following criteria are met:
    1) The device is shown to be more effective in treating or diagnosing a certain disease/condition.
    2) The device meets AT LEAST one of the following:
    -a. represents breakthrough technology
    -b. no approved or cleared alternatives exist
    -c. offers significant advantages over existing approved or cleared alternatives
    -d. device availability is in the best interest of patients

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    Lawrence Maddela
    Regulatory Affairs Specialist
    Irvine CA
    United States
    ------------------------------

    Original Message


  • 5.  RE: FDA Breakthrough Device Designation

    Posted 22-Mar-2021 08:12
    "1) The device is shown to be more effective in treating or diagnosing a certain disease/condition."

    That means outcomes data from a clinical study.

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    Michael Wienholt RAC
    Owner & Principal Consultant
    Raleigh NC
    United States
    ------------------------------

    Original Message


  • 6.  RE: FDA Breakthrough Device Designation

    Posted 26-Mar-2021 02:32
    Edited by Patrick Martin 26-Mar-2021 02:33
    Thanks to everyone who responded!  This helped me clarify things.  We have really great data comparing our device to the standard of care (surgery).  So we were making the case that we're better than surgery.  We should be making the case that we're better than other device for the same indication (per 21 U.S.C. 360e-3(b)(2)(C)).  Is this the correct thinking?  Appreciate the feedback.

    Original Message


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