Evaluating Benefit Risk for Diagnostic Devices

• Activity Number: 620
• Type: Invited
• Date/Time: Thursday, August 13, 2015 : 8:30 AM to 10:20 AM
• Sponsor: ENAR
• Author(s): Norberto Pantoja-Galicia* and Gene Anthony Pennello and Scott R. Evans and Jeanne Jiang
• Companies: FDA/CDRH and FDA and Harvard University and Harvard University
• Keywords: Diagnostic Device ; Benefit ; Risk ; Diagnostic Yield

Abstract

In determining the safety and effectiveness of a medical device, probable benefits and risks from its intended use are considered by the US FDA. The consequences of a particular clinical decision or outcome informed by a diagnostic device should be evaluated. Factors to consider when making these determinations include the risks from false-positive and false-negative results, the benefits from true-positive and true-negative results, compliance to the use of the diagnostic device and missing data. Quantitative analyses and examples to assess these factors in the context of Benefit-Risk evaluation for Diagnostic Devices will be discussed.