Assessment of the Benefit Risk tradeoff for diagnostic devices
View Presentation *Norberto Pantoja-Galicia, FDA Gene Pennello, FDA Keywords: Diagnostic Device, Benefit-Risk, tradeoff 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 risks is an important component in the determination that there are reasonable assurances of safety and effectiveness of a medical device. 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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Key Dates
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November 1 - December 17, 2013
Online proposal submission for a session, short course and Town Hall Open -
January 6 - March 11, 2014
Online proposal submission for Roundtables Open -
April 30 - May 28, 2014
Abstract Submission Open -
June 4, 2014
Online Registration Opens -
August 8 - August 22, 2014
Invited Abstract Editing -
August 11, 2014
Short Course materials due from Instructors -
September 1, 2014
Housing Deadline -
September 15, 2014
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 22 - September 24, 2014
Marriott Wardman Park, Washington, DC