Good Practice of Objective Propensity Score Design for Premarket Nonrandomized Medical Device Studies: A discussion with examples
Heng Li, FDA/CDRH/OSB  Nelson T Lu, FDA/CDRH  Vandana Mukhi, FDA/CDRH/OSB  *Yunling Xu, FDA/CDRH  Lilly Q Yue, FDA/CDRH 

Keywords: medical devices, Nonrandomized studies, Propensity score design

Nonrandomized comparative studies have been playing an important role in the premarket evaluation of medical devices. For such studies, objective study design using propensity score methodology is a core component. In this presentation, good practice of objective propensity score design for nonrandomized comparative studies will be discussed and illustrated with examples in a regulatory setting.