FDA Oversight of Medical Devices: Efforts and Developments

ISBN: 9781622571543 出版年：2012 页码：160 Matthew W Hill Daniel E Torres Nova Science

The FDA is responsible for overseeing the safety and effectiveness of medical devices sold in the United States. New devices are generally subject to FDA review via the 510(k) process, which determines if a device is substantially equivalent to another legally marketed device, or the more stringent premarket approval process, which requires evidence providing reasonable assurance that the device is safe and effective. This book examines whether the FDA is sufficiently meeting the performance goals and whether devices are reaching the market in a timely manner