Public Health Effectiveness of the FDA 510(k) Clearance Process

Released on by Institute of Medicine
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  • Public Health Effectiveness of the FDA 510(k) Clearance Process Book Detail

  • Author : Institute of Medicine
  • Release Date : 2010-10-04
  • Publisher : National Academies Press
  • Genre : Medical
  • Pages : 141
  • ISBN 13 : 0309162904
  • File Size : 45,45 MB
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Public Health Effectiveness of the FDA 510(k) Clearance Process by Institute of Medicine PDF Summary

Book Description: The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.

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Medical Devices and the Public's Health

Medical Devices and the Public's Health

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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