. "Appendix A: Workshop Agenda." Public Health Effectiveness of the FDA 510(k) Clearance Process: Measuring Postmarket Performance and Other Select Topics: Workshop Report. Washington, DC: The National Academies Press, 2011.
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Public Health Effectiveness of the FDA 510(k) Clearance Process: Measuring Postmarket Performance and Other Select Topics - Workshop Report
11:10
Premarket Notification: Analysis of FDA Recall Data
William H. Maisel, Director, Medical Device Safety Institute
11:50
FDA Recall Data Study
Ralph Hall, Distinguished Visiting Professor of Law, University of Minnesota Law School
12:30 PM
Lunch
Non-FDA Sources of Adverse Event Data
1:30
The National Cardiovascular Data Registries: Opportunitiesand 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
2:00
The VA-CART Program: Integration of Real-Time DataCollection 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
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
3:00
Automated Postmarket Safety Surveillance: The DELTASurveillance Project
Frederic S. Resnic, Director, Cardiac Catheterization Laboratory Brigham and Women’s Hospital, and Assistant Professor of Medicine, Harvard Medical School
