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  • 1.  Novel Technology in IVD

    This message was posted by a user wishing to remain anonymous
    Posted 21-Feb-2024 09:10
    This message was posted by a user wishing to remain anonymous

    Hello all,

    My company is developing an IVD Device and we are identifying preliminary hazards for the device using the ISO 24971 guidance (Annex A and H).

    In annex H which is particularly for IVD, I came across a question (H.2.1.2) that asks the manufacturer to define whether the device employs any New or Novel technology, attaching the screenshot for the reference.

    My question is, in the eyes of the FDA what do we mean by the new or novel technology? We have multiple patents for the device but it is essentially using a technology that is readily available and implemented in other Medical or non-medical devices.

    Looking forward to your opinion

    Thank you,

    Himang



  • 2.  RE: Novel Technology in IVD

    Posted 21-Feb-2024 09:56

    Himang,

    Based on your description that the general system is readily available and used in other medical devices, the device wouldn't be considered new or novel. In my opinion, the "new" or "novel" component warrants additional supporting details but doesn't substantively change obligations for a thorough risk analysis or informative device description.  

    Cheers,

    Andy Hadd



    ------------------------------
    Andrew Hadd
    Director of Regulatory Affairs
    Natera
    Austin TX
    United States
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    Original Message


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