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    Medical Devices and the FDA Regulation, User Fees and Tort Claims

    ISBN-10: 1622576748
    ISBN-13: 9781622576746
    Author(s): Gil Frazier, Brady Malone
    Description: Medical device regulation is complex, in part because of the wide variety of items that are categorized as medical devices. They may be simple tools used during medical examinations, such as tongue depressors and thermometers, or high-tech  More...
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    Publisher: Nova Science Publishers, Incorporated
    Binding: Paperback
    Pages: 139
    Size: 6.00" wide x 8.75" long x 0.50" tall
    Weight: 0.484
    Language: English

    Medical device regulation is complex, in part because of the wide variety of items that are categorized as medical devices. They may be simple tools used during medical examinations, such as tongue depressors and thermometers, or high-tech life-saving implants like heart valves and coronary stents. The medical device market has been characterized as including eight industry sectors: surgical and medical instrument manufacturing, surgical appliance and supplies, in vitro diagnostic products (IVDs, or laboratory tests), electromedical and electrotherapeutic apparatus, irradiation apparatus, dental equipment and supplies, ophthalmic goods, and dental laboratories. This book explores FDA regulation of medical devices with a focus on the user fee program and tort claims.

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