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.