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.
General
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