TL23: Design Considerations for Pivotal Clinical Investigations for Medical Devices
*Gregory Campbell, Food and Drug Administration  *Alicia Y Toledano, Statistics Collaborative, Inc. 


This roundtable will discuss the draft guidance issued by FDA on August 15, 2011, which addresses studies of therapeutic, aesthetic, and diagnostic devices. We will cover considerations common to different types of devices but distinct from studies of pharmaceuticals, including the roles of human factors and prior exploratory studies. We will also discuss the different types of study designs required to provide support for the intended use of different types of devices, and special statistical techniques required for analysis of these studies.