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.

Book Information
ISBN 9781622576746
Author Gil Frazier
Format Paperback
Page Count 127
Imprint Nova Science Publishers Inc
Publisher Nova Science Publishers Inc
Weight(grams) 212g