Keywords: medical devices, spontaneous reports, MAUDE, proactive, active, post-market surveillance, vigilance, trending, signal detection
Room: McKinley
This roundtable will discuss current developments in the application of statistical trending methods in active and continuous post-market surveillance of medical devices. First we will cover the respective roles of prospective studies, registries, observational studies, and continuous trending of spontaneous reports in the overall continuum of evidence generation. Next we will discuss data sources such as trial and registries, insurance claims and electronic medical/health records (EMRs/EHRs), spontaneous reporting databases such as MAUDE and EUDAMED, recall databases such as IMDD, and manufacturer collected complaints. Finally we will share on statistical considerations in analyses of these data sources, how to integrate evidence, and contextualization within the evolving regulatory landscape domestically (MDIC, NEST) and internationally (EU-MDR).
Potential attendees contacted: Zhiheng Xu, Statistician, FDA CDRH (confirmed interest) Ted Lystig, Sr. Dir Biostats, Medtronic (confirmed interest) Paul Coplan, VP Epidemiology, J&J (confirmed interest) Jennifer Wood, Sr. Dir Epidemiology, J&J (confirmed interest)