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Abstract Details

Activity Number: 165
Type: Topic Contributed
Date/Time: Monday, July 30, 2012 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #305319
Title: Using Quantitative Decision Analysis in the Regulation of Medical Devices
Author(s): Telba Irony*+
Companies: FDA
Address: 10903 New Hampshire Ave, Silver Spring, MD, 20993-0002, United States
Keywords: Quantitative Decision Analysis ; Risk - Benefit Trade Off
Abstract:

The Center for Devices and Radiological Health (CDRH) has started an initiative to use quantitative decision analysis methods for medical device regulation across the total product life cycle. This talk presented case studies to illustrate how the quantitative decision analysis can be used at CDRH.


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