Conference Program

An Overview of Statistical Challenges in Designing Studies to Evaluate Diagnostic Devices: Regulatory Perspective (303664)

View Presentation

*Qin Li, FDA/CDRH 

Keywords: Diagnostic devices

Statistical consideration in designing and evaluating diagnostic devices is different from that for therapeutic devices. Even within the area of diagnostic devices, the study design can be very different for different intended use of the device. For example, the study design should consider when the device is used, how it is used and who use it, etc. In this presentation, the speaker will provide an overview of several common problems and challenges one can face when evaluating different types of diagnostic devices from a regulatory perspective.