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  • 1.  FDA definition of Novel device

    This message was posted by a user wishing to remain anonymous
    Posted 14 days ago
    This message was posted by a user wishing to remain anonymous

    Where can I find the FDA definition of a novel device? What is considered a novel device? 



  • 2.  RE: FDA definition of Novel device

    Posted 14 days ago

    Hello Anon,

    FDA does not specifically define what is or is not a novel medical device.  However, there are some verbiage around this in the Breakthrough Designation programme, the De Novo determination guidance document, and the Benefits versus Risk Determination guidance document.  They do not necessarily define novel, but they do have a lot of information about innovative products, pathways to market for these, and FDA supporting innovation - which some would say falls into this area of being a novel medical device https://www.fda.gov/about-fda/cdrh-innovation/activities-support-medical-device-innovators.  In the United States there is also a lot more to innovative (novel) devices as well touching on health technology, CMS approval, and reimbursement.



    ------------------------------
    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Principal Strategy Consultant
    NAMSA
    ------------------------------

    Original Message


  • 3.  RE: FDA definition of Novel device

    This message was posted by a user wishing to remain anonymous
    Posted 13 days ago
    This message was posted by a user wishing to remain anonymous

    "Novel devices include those brought to market through the premarket approval (PMA), humanitarian device exemption (HDE), and De Novo pathways, as well as a subset of those that are brought to market with 510(k) clearance or Emergency Use Authorization (EUA). Of the thousands of 510(k) clearances every year, the FDA considers only those devices with a breakthrough designation to be novel. In addition, in 2020, we are including first-of-a-kind devices authorized under our EUA authority as novel devices. Novel or innovative does not simply mean "new." They address an unmet need, or may be safer or more effective than currently available alternatives."

    - Jeff Shuren

    https://www.fda.gov/news-events/fda-voices/reflections-record-year-novel-device-innovation-despite-covid-19-challenges


    Original Message


  • 4.  RE: FDA definition of Novel device

    This message was posted by a user wishing to remain anonymous
    Posted 10 days ago
    This message was posted by a user wishing to remain anonymous

    Thank you Richard and Jeff this is very helpful. 


    Original Message


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