Public Health Effectiveness of the FDA 510(k) Clearance Process Measuring Postmarket Performance and Other Select Topics: Workshop Report (2011) / Chapter Skim
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. As part of its fact-finding process, the IOM Committee on the Public Health Effectiveness of the FDA's 510(k)
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clearance process sufficiently protects patients and promotes public health. Specifically, the IOM committee will answer two principal questions: • Does the current 510(k)
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The committee also heard a presentation on the issues associated with the use of computer software in medical devices and additional perspectives on device approval and clearance processes. This report summarizes the views expressed by workshop participants.
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The workshop agenda, biographic sketches of the speakers and panelists, and the two commissioned papers presented at the workshop are available as appendixes. REFERENCES FDA (Food and Drug Administration)
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