Online Program

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Tuesday, September 24
Tue, Sep 24, 11:45 AM - 1:00 PM
Various Rooms
Roundtable Discussions

TL07: Challenges in Evaluating in Vivo Diagnostic Devices with Quantitative and/or Qualitative Outputs (300863)

*Bipasa Biswas, FDA/CDRH 
*Saryet Kucukemiroglu, FDA 

Keywords: Diagnostic Devices, device output, study protocol

Room: McKinley

This is a general topic on challenges associated with review of in vivo diagnostic devices. Many in vivo diagnostic devices involve multiple output and without clear specification of how these are to be interpreted in clinical practice. Diagnostic devices with quantitative and or qualitative output have different statistical challenges. This session will discuss the expectations in study protocol, device description -output(s), endpoints, hypothesis statements, and study designs.