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  • 1.  FDA De Novo Attention

    Posted 06-Nov-2023 09:11

    We submitted a DeNovo for SaMD using predictive AI. The admin review was finished and the technical review began on October 1, 2023. Since then FDA has sent interactive review questions weekly and proposed meetings. 

    Our consultant seems very happy about this heavy communication going back and forth and suggests it could mean FDA thinks this SaMD has potential benefits as a product above other products in their mix at the moment.

    Is that thought rational? Does FDA consider all devices with the same priority for review or does it separate the ones it thinks are promising and give them more attention?



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    Edward Panek
    VP, QA/RA
    Med Device
    USN Veteran
    Research into Neural Nets - https://www.twitch.tv/edosani
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  • 2.  RE: FDA De Novo Attention

    Posted 07-Nov-2023 08:01

    Ed, does your device have Breakthrough Designation? That affords a formal priority review, however unlike drug priority reviews, this does not change the user fee goal date. In select circumstances FDA may prioritize certain reviews, like was seen during the pandemic due to shortages or COVID-19 related submissions, however that is not standard practice. Typically, goal dates are regularly followed, with the review divisions differing in workloads and achieving user fee goal rates (which can be checked via the most recent MDUFA quarterly report).

    IMHO, I wouldn't read much into the volume of questions except that you have an active reviewer, and possibly a good one, but that doesn't necessarily reflect on the chances of the de novo being granted. A lot more depends on the content of those interactions but that still amounts to an educated guess (though seasoned Reg professionals may have a reasonable read on such things).

    Beat of luck!



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    Jonathan Amaya-Hodges
    Director, Technical Services
    Sharon MA
    United States
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    Original Message


  • 3.  RE: FDA De Novo Attention

    Posted 08-Nov-2023 00:45
    Edited by Mbaboh Ngah-Wanneh 08-Nov-2023 00:45
    Hello Ed,
     
    Given that this is a  De Novo submission, it only makes sense that the FDA would want to interact more to get a better understanding of the device and its intended use. I don't think the volume of communication suggests what the FDA's decision is going to be. Just like Jonathan pointed out, it also depends on the nature of these interactions and what kind of questions the FDA is asking.
     
    Unless your Device has a Breakthrough designation,  the FDA does not give more attention to some devices over others.



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    Mbaboh Ngah-Wanneh
    Graduate Student RAS
    St.Cloud State University
    Plymouth
    MN
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    Original Message


  • 4.  RE: FDA De Novo Attention

    Posted 08-Nov-2023 04:41

    Hi Ed

    We had the same situation and indeed the FDA was very interested in our technology, but they also had concerns, so eventually it depends on what kind of questions they are asking and how satisfied they are with the answers they get. I think it is less related to actually prioritizing products, although in our case we believe that a lot of politics were involved unfortunately. 

    Hope you will get it :)



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    Ella Sheiman
    Haifa
    Israel
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    Original Message


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