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Abstract Details
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Activity Number:
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19
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Type:
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Topic Contributed
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Date/Time:
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Sunday, July 31, 2011 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #302038 |
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Title:
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Two Case Studies of Using Quantitative Decision Analysis in the Regulation of Medical Devices
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Author(s):
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Xuefeng Li*+
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Companies:
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U.S. Food and Drug Administration
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Address:
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10903 New Hamshire Ave, Silver Spring, MD, 20903,
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Keywords:
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Medical Devices ;
Quantitative decision analysis
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Abstract:
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We all know that the main function of the Center for Devices and Radiological Health (CDRH) is to make regulatory decisions. In 2006, CDRH has started an initiative to use quantitative decision analysis methods for medical device regulation across the total product life cycle. It is expected that the quantitative decision analysis methods may streamline and improve the current decision making processes within the Center. This talk presented two artificial cases studies to illustrate how the quantitative decision analysis can be used at CDRH. The first case involves a post market issue about a diagnostic device. The second case also involves a post-market question about an implantable device.
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The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
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