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  • 1.  Notice of Change SaMD accessory

    Posted 07-Jan-2022 09:44
    Hello,

    Has anyone had luck submitting a non-significant notice of change to an MDDS introducing a SaMD enabled accessory?  The MDDS is also SW with AI-enabled, this change will take the device from MDDS to a Class A monitoring device.  The client wants to try to pursue it as a non-significant change.

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    Gretchen Upton
    RAC, CQA, CCRP
    QA/RA consultant
    San Antonio, TX
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  • 2.  RE: Notice of Change SaMD accessory

    Posted 09-Jan-2022 11:23
    Hello Gretchen,

    It would be hard to answer without knowing the jurisdiction.  As you mentioned MDDS, maybe referring to US FDA?  But the you mentioned Class A, is this in reference to IEC 62304?  There are some mixed terms here.  In many regulatory regions, a non-significant change does not require submitting anything as usually an internal documentation generated would be sufficient.  Also the specific type of software change would need to be known to provide further information.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: Notice of Change SaMD accessory

    Posted 13-Jan-2022 02:20
    Hello Gretchen!

    There are two things in your question that makes me concerned about pursuing a non-significant change.
    Firstly, the shift from a plain MDDS to a product including SaMD features. To me, this sounds like you leave the easy, relaxed path for MDDS(1) and enter a more regulated world.
    Secondly, just mentioning AI... If it is introduced or used by the SaMD features, I find it unlikely that the FDA would consider such change non-significant. But perhaps AI is already present in the MDDS and not utilized by the SaMD features? Then it would be a more straightforward discussion! ;)


    (1) https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-data-systems-medical-image-storage-devices-and-medical-image-communications-devices

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    Christian Kaestner
    Sweden
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    Original Message


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