Medical Devices & the FDA : Regulation, User Fees & Tort Claims
Book Details
Format
Paperback / Softback
ISBN-10
1622576748
ISBN-13
9781622576746
Publisher
Nova Science Publishers Inc
Imprint
Nova Science Publishers Inc
Country of Manufacture
US
Country of Publication
GB
Publication Date
Mar 4th, 2013
Print length
127 Pages
Weight
216 grams
Dimensions
23.00 x 16.40 x 0.80 cms
Product Classification:
Biomedical engineering
Ksh 15,300.00
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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.
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