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.
Product details
- Paperback | 127 pages
- 155 x 230 x 12.7mm | 212g
- 04 Mar 2013
- Nova Science Publishers Inc
- New York, United States
- English
- 1622576748
- 9781622576746
Download Medical Devices & the FDA : Regulation, User Fees & Tort Claims (9781622576746).pdf, available at ebookdownloadfree.co for free.
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