Creating 21st Century Medical Devices
ISBN-10: 1608767736
ISBN-13: 9781608767731
$115.00
Book Specs
Binding
Trade Cloth
Publisher
Nova Science Pub Inc
Published on
Apr 1, 2010
Edition
1st Edition
Dimensions
7.25x0.75x10.00 Inches
Weight
1.23 Pounds
About the Book
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.