Medical Devices and the FDA
by Gil Frazier (Editor), Brady Malone (Editor)
ISBN-10: 1622576748
ISBN-13: 9781622576746
$52.00
Book Specs
Binding
Trade Paper
Publisher
Nova Science Pub Inc
Published on
Jan 1, 2013
Edition
1st Edition
Dimensions
6.00x0.50x8.75 Inches
Weight
0.48 Pounds
About the Book
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.