Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years

by Committee on the Public Health Effective, Institute of Medicine, Board on Population Health and Public Health Practice, et al.

Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have...

• Format: Paperback
• Language: English
• ISBN: 0309212421
• ISBN13: 9780309212427
• Release Date: November 2011
• Publisher: National Academies Press
• Length: 318 Pages
• Weight: 1.14 lbs.
• Dimensions: 0.9" x 6.0" x 8.9"