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This roundtable will discuss the draft guidance issued by FDA on August 15, 2011, which addresses studies of therapeutic, aesthetic, and diagnostic devices.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.
April 30 - May 22, 2013
Invited Abstract Submission Open
June 4, 2013
Online Registration Opens
August 9 - August 23, 2013
Invited Abstract Editing
August 23, 2013
Short Course materials due from Instructors
August 26, 2013
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC