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

      Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process,Institute of Medicine

      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…

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      Cover image for Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report
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      Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report

      Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process,Institute of Medicine

      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…

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      Available to order, ships in approx 4 weeksAvailable to order

      Cover image for Public Health Effectiveness of the FDA 510(k) Clearance Process: Measuring Postmarket Performance and Other Select Topics: Workshop Report
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      Public Health Effectiveness of the FDA 510(k) Clearance Process: Measuring Postmarket Performance and Other Select Topics: Workshop Report

      Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process,Institute of Medicine

      The Food and Drug Administration (FDA) is responsible for ensuring that medical devices are safe and effective before they go on the market. Section 510(k) of the Federal Food, Drug…

      $152.99

      Available to order, ships in approx 4 weeksAvailable to order