Statistical Considerations and Approaches on Using OUS Data to Support a Pre-Market Application of Medical Devices

• Activity Number: 634
• Type: Topic Contributed
• Date/Time: Thursday, August 8, 2013 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Nelson Lu*+ and Yunling Xu
• Companies: Center for Devices & Radiological Health, FDA and FDA/CDRH

Abstract

The number of US medical device pre-market submissions utilizing OUS data has been increasing over the last decade. When the observed treatment effect in the US is worse than that of the OUS, it may pose a great challenge to the regulatory decision making. Without a pre-specified decision rule, the regulatory decision may become less predictable and less transparent. To investigate this issue, we review the current practice and examine some available methods. We also propose some approaches in an attempt to address the need.