Medical Devices & the FDA

Regulation, User Fees & Tort Claims

Buch | Softcover

127 Seiten

2013
Nova Science Publishers Inc (Verlag)
978-1-62257-674-6 (ISBN)

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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.

Preface; FDA Regulation of Medical Devices; The FDA Medical Device User Fee Program; Riegel v. Medtronic, Inc.: Federal Preemption of State Tort Law Regarding Medical Devices with FDA Premarket Approval; Index.

Verlagsort	New York
Sprache	englisch
Maße	155 x 230 mm
Gewicht	212 g
Themenwelt	Medizin / Pharmazie ► Physiotherapie / Ergotherapie ► Orthopädie
Themenwelt	Technik ► Medizintechnik
ISBN-10	1-62257-674-8 / 1622576748
ISBN-13	978-1-62257-674-6 / 9781622576746
Zustand	Neuware