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