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Book Synopsis
In order to be legally manufactured in the U.S., medical devices must be approved by the Food and Drug Administration (FDA), the agency responsible for protecting the public health by assuring the safety, efficacy, and security of human medical devices and other products. The regulation of medical devices can affect their cost, quality, and availability in the health care system. This book discusses the legislative history of medical device regulation, describes the FDA''s approval process for medical devices, and provides an overview of the medical device related legislative issues facing Congress.

Creating 21st Century Medical Devices:

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A Hardback by Nelson E Parker

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    View other formats and editions of Creating 21st Century Medical Devices: by Nelson E Parker

    Publisher: Nova Science Publishers Inc
    Publication Date: 13/07/2011
    ISBN13: 9781608767731, 978-1608767731
    ISBN10: 1608767736
    Also in:
    Medical equipment, devices and techniques

    Description

    Book Synopsis
    In order to be legally manufactured in the U.S., medical devices must be approved by the Food and Drug Administration (FDA), the agency responsible for protecting the public health by assuring the safety, efficacy, and security of human medical devices and other products. The regulation of medical devices can affect their cost, quality, and availability in the health care system. This book discusses the legislative history of medical device regulation, describes the FDA''s approval process for medical devices, and provides an overview of the medical device related legislative issues facing Congress.

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