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.
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