Medical Devices & the FDA: Regulation, User Fees & Tort Claims
Author:   Gil Frazier ,  Brady Malone
Publisher:   Nova Science Publishers Inc
ISBN:  

9781622576746


Pages:   127
Publication Date:   04 March 2013
Format:   Paperback
Availability:   Available To Order   Availability explained
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Medical Devices & the FDA: Regulation, User Fees & Tort Claims


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Overview

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.

Full Product Details

Author:   Gil Frazier ,  Brady Malone
Publisher:   Nova Science Publishers Inc
Imprint:   Nova Science Publishers Inc
Weight:   0.212kg
ISBN:  

9781622576746


ISBN 10:   1622576748
Pages:   127
Publication Date:   04 March 2013
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Paperback
Publisher's Status:   Active
Availability:   Available To Order   Availability explained
We have confirmation that this item is in stock with the supplier. It will be ordered in for you and dispatched immediately.

Table of Contents

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.

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