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Activity Number: 188
Type: Contributed
Date/Time: Monday, August 10, 2015 : 10:30 AM to 12:20 PM
Sponsor: Section on Medical Devices and Diagnostics
Abstract #315909 View Presentation
Title: Considerations in Using Registry Data to Support Pre-Market Applications of Medical Devices
Author(s): Nelson Lu* and Lilly Yue and Yunling Xu
Companies: FDA/CDRH and FDA/CDRH and FDA/CDRH
Keywords: registry ; observational comparative study ; propensity score ; data quality
Abstract:

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..


Authors who are presenting talks have a * after their name.

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