Medical Devices & the FDA

Medical Devices & the FDA

Sale price  £63.74 Regular price  £84.99
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Medical Devices & the FDA

Medical Devices & the FDA

Regulation, User Fees & Tort Claims

Written by Gil Frazier and Brady Malone

Sale price  £63.74 Regular price  £84.99
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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.
ISBN-13
9781622576746
Publication date
4 March 2013
Format
Paperback
Pages
127
Dimensions
230 x 155 mm
Language
English

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