TL10: Statistical Issues in Balancing Pre-market and Post-market Studies for Medical Devices
*Terri Kang Johnson, FDA/CDRH 

Keywords: post-market study, benefit/risk

Under FDA Safety and Innovation Act (FDASIA), emphasis has been shifting from pre-market to post-market in the regulatory setting for medical devices, as long as there is no strong safety concern. Immediate consequences for the pre-market studies may be shorter follow-up time and larger overall type I error rate to name a few. This Roundtable is to offer an opportunity to get together and discuss the statistical implications from this trend: how does this affect the benefit and risk ratio.