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Book Synopsis
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 pre-market 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.

FDA Oversight of Medical Devices: Efforts &

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    A Hardback by Matthew W Hill, Daniel E Torres

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      Book details

      Publisher Nova Science Publishers Inc
      Published 14 November 2012
      ISBN-13 9781622570898
      978-1622570898
      ISBN-10 1622570898
      Also in:
      Law Regulation of medicines and medical devices

      Description

      Book Synopsis
      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 pre-market 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.

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