Statistical Review and Other Developments for New Medical Devices
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*Gregory Campbell, Food and Drug Administration 

Keywords: devices, FDA

A number of important statistical issues have arisen in medical devices in the past year. Topics from FDA Advisory Committee meetings are highlighted, including 1) the treatment of missing data using tipping point analysis, 2) propensity score methodology in the design and analysis of non-randomized studies, 3) treatment by gender interactions, and 4) benefit-risk for devices to treat obesity. Several FDA guidances have been released including ones on pivotal clinical study design, early feasibility and risk-benefit. A report about the number of submissions FDA receives for medical devices as well as the size of the statistical community in the medical device industry and in FDA’s CDRH.