Welcome and Opening Remarks
David Challoner, Chair, IOM Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process |
Play Flash Video
|
|
Trustworthy Medical Device Software
Kevin Fu, University of Massachusetts Amherst |
Play Flash Video
|
|
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 |
Play Flash Video
|
|
Issues With the Present FDA On the Matter Of FDA 510(k) Clearance
Robert E. Fischell, Founder and Chief Technology Officer, Neuralieve, Inc.
|
Play Flash Video
|
|
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
|
Play Flash Video
|
|
Premarket Notification: Analysis of FDA Recall Data
William H. Maisel, Director, Medical Device Safety Institute
|
Play Flash Video
|
|
FDA Recall Data Study
Ralph Hall, Distinguished Visiting Professor of Law, University of Minnesota Law School
|
Play Flash Video
|
|
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
|
Play Flash Video
|
|
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
|
Play Flash Video
|
|
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
|
Play Flash Video
|
|
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
|
Play Flash Video
|
|
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
|
Play Flash Video
|
|
|