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  • Book
    Jonathan S. Kahan, Michael S. Heyl.
    Contents:
    The framework for regulation of medical devices
    The 510(k) premarket notification process
    Device modifications requiring a 510(k) notice
    FDA regulation of medical device software and digital health technology
    The investigational device exemption application : overview of the IDE process and humanitarian devices
    Medical device clinical studies
    The premarket approval application
    Review of a premarket approval application
    PMA supplements
    Medical device reclassification
    The regulation of in vitro diagnostics
    The quality system regulation
    Compliance
    Medical device exports and imports
    Product jurisdiction and the regulation of combination products
    Working well with FDA.
    Print Unavailable: Checked out Recall Item
    Location
    Version
    Call Number
    Items
    Books: General Collection (Downstairs)
    2020
    KF3827.M4 K34 2020
    1