A Note on Good Practice of Objective Propensity Score Design for Premarket Nonrandomized Medical Device Studies with an Example

Heng LiCenter for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD, USA

Vandana MukhiCenter for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD, USACorrespondence[email protected]

Nelson LuCenter for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD, USA

Yun-Ling XuCenter for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD, USA

Lilly Q. YueCenter for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD, USA

ABSTRACT

In this short note, we highlight some key elements of the process of submitting an investigational device exemption of a nonrandomized clinical study that involves the use of propensity score methodology. Focus is given to the assessment of balance for propensity score stratification.

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A Note on Good Practice of Objective Propensity Score Design for Premarket Nonrandomized Medical Device Studies with an Example

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A Note on Good Practice of Objective Propensity Score Design for Premarket Nonrandomized Medical Device Studies with an Example

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