Welcome and Opening Remarks

David Challoner, Chair, IOM Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process

Trustworthy Medical Device Software

Kevin Fu, University of Massachusetts Amherst

Strength of Study Evidence Examined by the FDA in Premarket Approval of Cardiovascular Devices

Rita Redberg, Professor of Medicine UCSF Medical Center and Editor, Archives of Internal Medicine

Issues With the Present FDA On the Matter Of FDA 510(k) Clearance

Robert E. Fischell, Founder and Chief Technology Officer, Neuralieve, Inc.

Break

FDA Post-Market Surveillance

Monitoring Device Safety: CDRH's Current System and Vision for the Future

Susan Gardner, Director of the Center for Devices and Radiological Health's (CDRH's) Office of Surveillance and Biometrics

Premarket Notification: Analysis of FDA Recall Data

William H. Maisel, Director, Medical Device Safety Institute

FDA Recall Data Study

Ralph Hall, Distinguished Visiting Professor of Law, University of Minnesota Law School

Lunch

Non-FDA Sources of Adverse Event Data

The National Cardiovascular Data Registries: Opportunities and Challenges in Post-Market Surveillance

Frederick A Masoudi, MD, MSPH, Associate Professor of Medicine, Denver Health Medical Center & University of Colorado; Senior Medical Officer, National Cardiovascular Data Registries

The VA-CART Program: Integration of Real-Time Data Collection into the Process of Clinical Care

Paul D. Varosy, Director of Cardiac Electrophysiology, VA Eastern Colorado Health Care System, Project Director, CART-EP, and Assistant Professor of Medicine, University of Colorado Denver

The Centers for Education and Research on Therapeutics (CERTs) program

Eric D. Peterson, Fred Cobb MD Distinguished Professor of Medicine and Associate Director of the Duke University Medical Center, and Director CV Research of the Duke Clinical Research Institute

Automated Post-Market Safety Surveillance: The DELTA Surveillance Project

Frederic S. Resnic, Director, Cardiac Catheterization Laboratory Brigham and Women's Hospital, and Assistant Professor of Medicine, Harvard Medical School

Break

Post-Market Surveillance of Medical Devices

Panel Discussion

Moderated by Lazar Greenfield, committee member

Panelists:

• Workshop speakers: Susan Gardner, Ralph Hall, William Maisel, Frederick Masoudi, Eric D. Peterson, Fred Resnic, and Paul Varosy
• Susan Alpert, Senior Vice President - Chief Regulatory Officer, Medtronic, Inc.
• Larry Kessler, Professor and Chair, Department of Health Services, School of Public Health, University of Washington (invited)

Adjourn