Public Health Effectiveness of the FDA 510(k) Clearance Process: Measuring Postmarket Performance and Other Select Topics: Workshop Report (2011)
Chapter: Appendix A: Workshop Agenda
A
Workshop Agenda
Wednesday, July 28, 2010
Room 100
Keck Center of the National Academies
500 Fifth Street, NW
Washington, DC
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8:30 AM |
Welcome and Opening Remarks David Challoner, Chair, IOM Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process |
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8:40 |
Trustworthy Medical Device Software Kevin Fu, University of Massachusetts Amherst |
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9:20 |
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 |
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10:00 |
Issues with the Present FDA on the Matter of FDA 510(k) Clearance Robert E. Fischell, Founder and Chief Technology Officer, Neuralieve Inc. |
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10:20 |
Break |
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FDA Postmarket Surveillance |
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10:30 |
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 |
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11:10 |
Premarket Notification: Analysis of FDA Recall Data William H. Maisel, Director, Medical Device Safety Institute |
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11:50 |
FDA Recall Data Study Ralph Hall, Distinguished Visiting Professor of Law, University of Minnesota Law School |
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12:30 PM |
Lunch |
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Non-FDA Sources of Adverse Event Data |
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1:30 |
The National Cardiovascular Data Registries: Opportunities and Challenges in Postmarket Surveillance Frederick A. Masoudi, MD, MSPH, Associate Professor of Medicine, Denver Health Medical Center & University of Colorado; Senior Medical Officer, National Cardiovascular Data Registries |
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2:00 |
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 |
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2:30 |
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 |
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3:00 |
Automated Postmarket 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 |
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3:30 |
Break |
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3:40 |
Postmarket Surveillance of Medical Devices Panel Discussion Moderated by Lazar Greenfield, committee member Panelists:
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5:30 |
Adjourn |
