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Book Synopsis
The FDA is responsible for overseeing the safety and effectiveness of medical devices sold in the United States. New devices are generally subject to FDA review via the 510(k) process, which determines if a device is substantially equivalent to another legally marketed device, or the more stringent pre-market approval process, which requires evidence providing reasonable assurance that the device is safe and effective. This book examines whether the FDA is sufficiently meeting the performance goals and whether devices are reaching the market in a timely manner.

FDA Oversight of Medical Devices: Efforts &

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A Hardback by Matthew W Hill, Daniel E Torres

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    View other formats and editions of FDA Oversight of Medical Devices: Efforts & by Matthew W Hill

    Publisher: Nova Science Publishers Inc
    Publication Date: 14/11/2012
    ISBN13: 9781622570898, 978-1622570898
    ISBN10: 1622570898
    Also in:
    Regulation of medicines and medical devices

    Description

    Book Synopsis
    The FDA is responsible for overseeing the safety and effectiveness of medical devices sold in the United States. New devices are generally subject to FDA review via the 510(k) process, which determines if a device is substantially equivalent to another legally marketed device, or the more stringent pre-market approval process, which requires evidence providing reasonable assurance that the device is safe and effective. This book examines whether the FDA is sufficiently meeting the performance goals and whether devices are reaching the market in a timely manner.

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