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Keyword Search Criteria: medical devices returned 5 record(s)
Sunday, 07/31/2016
Developing and Validating Visual Assessment Tools for Use in Medical Device Trials
Alvin Van Orden, FDA
3:05 PM

Monday, 08/01/2016
Best Practices for Communicating with FDA CDRH Statistical Reviewers
Christopher Mullin, NAMSA


Design and Analysis of Multiregional Clinical Trials in Evaluation of Medical Devices: Some Points to Consider from a Regional Regulatory Perspective
Yunling Xu, FDA/CDRH; Nelson LU, FDA/CDRH
8:55 AM

Thursday, 08/04/2016
Different Success Criteria in the Performance Evaluation of Diagnostic Devices
Norberto Pantoja-Galicia, FDA/CDRH; Gene Pennello, FDA/CDRH/OSB/DBS
9:15 AM

Creating a Biomarker Signature for a Companion Diagnostic Using Bootstrapping and Aggregating Thresholds from Tree-Based Models
Raj Chandran
9:35 AM

 
 
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