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    Labelling) : Labeling Guidelines in Future)

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    Sameer Jareen
    The FDA outlines their action plan for regulating AI/ML-based software as a medical device (SaMD). They propose requiring manufacturers to disclose predetermined specifications for how the algorithm will learn and change over time. Changes made according to these specifications should not require new premarket review, unless introducing new risks. The FDA will provide guidance on good machine learning practices and labeling requirements and encourage the identification and elimination of algorithmic bias through diverse training data and real-world performance monitoring.

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    Labelling) : Labeling Guidelines in Future)

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    Sameer Jareen
    49 views2 pages
    The FDA outlines their action plan for regulating AI/ML-based software as a medical device (SaMD). They propose requiring manufacturers to disclose predetermined specifications for how the algorithm will learn and change over time. Changes made according to these specifications should not require new premarket review, unless introducing new risks. The FDA will provide guidance on good machine learning practices and labeling requirements and encourage the identification and elimination of algorithmic bias through diverse training data and real-world performance monitoring.

    Original Title

    AI_ML-SAMD FDA New Perspectives_Sumarry

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    The FDA outlines their action plan for regulating AI/ML-based software as a medical device (SaMD). They propose requiring manufacturers to disclose predetermined specifications for how the algorithm will learn and change over time. Changes made according to these specifications should not require new premarket review, unless introducing new risks. The FDA will provide guidance on good machine learning practices and labeling requirements and encourage the identification and elimination of algorithmic bias through diverse training data and real-world performance monitoring.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    49 views2 pages

    Labelling) : Labeling Guidelines in Future)

    Uploaded by

    Sameer Jareen
    The FDA outlines their action plan for regulating AI/ML-based software as a medical device (SaMD). They propose requiring manufacturers to disclose predetermined specifications for how the algorithm will learn and change over time. Changes made according to these specifications should not require new premarket review, unless introducing new risks. The FDA will provide guidance on good machine learning practices and labeling requirements and encourage the identification and elimination of algorithmic bias through diverse training data and real-world performance monitoring.

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    Artificial Intelligence/Machine Learning (AI/ML)-Based.

    (SaMD) Action Plan – Summary

    FDA New Perspectives


    Predetermined Change SaMD Pre-Specifications (SPS): "what" aspects the manufacturer intends
    Control Plan to change through learning.
    Algorithm Change Protocol (ACP): "how" the algorithm will learn and
    change while remaining safe and effective.

    SPS/ACP should be Predetermined and disclosed in Premarket


    notification, Changes Made on SPS/ACP should not fall under any of the
    below Criteria that will require a new premarket submission:
    (as per Link )
    • A change that introduces a new risk or modifies an existing
    risk that could result in significant harm;
    • A change to risk controls to prevent significant harm; and
    • A change that significantly affects clinical functionality or
    performance specifications of the device.

    Good Machine Learning FDA Will be releasing harmonization of Good Machine Learning Practice
    Practice (GMLP) development in future.
    Some standards FDA currently approve and Participates in development:
    • Institute of Electrical and Electronics Engineers (IEEE) P2801
    Artificial Intelligence Medical Device Working Group
    • the International Organization for Standardization/ Joint
    Technical Committee 1/ Subcommittee 42 (ISO/ IEC JTC 1/SC 42)
    • (AAMI)/ British Standards Institution (BSI) Initiative on AI in
    medical technology.
    • Xavier AI World Consortium Collaborative Community and the
    Pathology Innovation Collaborative Community
    • International Medical Device Regulators Forum (IMDRF)

    Patient-Centered FDA promotes Manufacturers to be more transparent of these devices to


    Approach (Focused on users, and to patients more broadly, about the functioning of AI/ML-
    Labelling) based devices to ensure that users understand the benefits, risks, and
    limitations of these devices.

    Also, to clearly describe the data that were used to train the algorithm,
    the relevance of its inputs, the logic it employs the role intended to be
    served by its output, and the evidence of the device’s performance in the
    Product Label (when possible – Not Mandatory, FDA will release SAMD
    labeling guidelines in future)

    Regulatory Science In Summary FDA encourages methods that would identify and eliminate
    Methods Related to bias and improve robustness and resilience of these algorithms to
    Algorithm Bias & withstand changing clinical inputs and conditions.
    Robustness
    Also Expects a racially and ethnically diverse intended patient population
    to train the algorithms to eliminate bias.
    Real-World Performance FDA will support the piloting of real-world performance monitoring by
    (RWP) working with stakeholders on a voluntary basis (for AI/ML-based SaMD)

    Source : https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-
    and-machine-learning-software-medical-device

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