8:35 am – 10:45 am Setting the Stage: Introductory Session
Introductions (Danica Marinac-Dabic.FDA),
Goals for the Day (Peter McCulloch, Oxford, Art Sedrakyan, Cornell)
8:55 am The challenges of medical device & surgical procedure regulation, William Maisel (A summary of the major issues from science and policy perspectives)
9:15 am Methodological paradigms for evaluating innovation in medical devices (Mary Beth) 9:35 am Conceptual framework for evidence evaluation for devices & procedures ( Art)
9:45 am IDEAL: What it is and why it is relevant? – (Peter)