TL46: Use of propensity score stratification in non-randomized studies
Heng Li, FDA/CDRH/OSB  *Vandana Mukhi, FDA/CDRH/OSB 

Keywords: stratification, historical control

With the increased adoption of propensity score approach in the medical device premarket studies, we will share our experience and discuss few key elements that go into an investigational device exemption (IDE) for such studies from a regulatory perspective.