Abstract Details
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Activity Number:
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450
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 6, 2014 : 8:30 AM to 10:20 AM
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Sponsor:
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Section on Medical Devices and Diagnostics
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Abstract #311711
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Title:
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Assessing the Benefit Risk Tradeoff in Diagnostic Devices
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Author(s):
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Norberto Pantoja-Galicia*+ and Gene Pennello
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Companies:
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FDA and FDA
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Keywords:
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Benefit-Risk ;
Diagnostic ;
Medical Devices
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Abstract:
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In the biostatistical literature, emphasis is being placed on risk-benefit, decision analysis, and sensitivity analysis to assess medical products. Consideration of probable benefits and probable risks is a key component in the determination that there are reasonable assurances of safety and effectiveness of a medical device. Therefore the consequences of a particular clinical decision informed by the diagnostic device should be taken into consideration when evaluating such device. We will discuss examples and analyses that may aid in the assessment of the benefit-risk tradeoff in Diagnostic Devices.
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Authors who are presenting talks have a * after their name.
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