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Nelson Lu

US Food and Drug Administration



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Lilly Q. Yue

U.S. Food and Drug Administration



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Yunling Xu

US Food and Drug Administration



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188 – Design and Analysis of Pivotal Studies for Medical Devices

Considerations in Using Registry Data to Support Pre-Market Applications of Medical Devices

Sponsor: Section on Medical Devices and Diagnostics
Keywords: registry, observational comparative study, propensity score, data quality

Nelson Lu

US Food and Drug Administration

Lilly Q. Yue

U.S. Food and Drug Administration

Yunling Xu

US Food and Drug Administration

In some situations, data from national/international registries may be utilized to support pre-market application of medical devices. In this paper, statistical and regulatory challenges are discussed on obtaining valid statistical inference utilizing registry data. Examples for potential use of registry data are presented..

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