A
Workshop Agenda

Wednesday, July 28, 2010

Room 100

Keck Center of the National Academies

500 Fifth Street, NW

Washington, DC

8:30 AM

Welcome and Opening Remarks

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

8:40

Trustworthy Medical Device Software

Kevin Fu, University of Massachusetts Amherst

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

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.

10:20

Break

 

FDA Postmarket Surveillance

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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A Workshop Agenda Wednesday, July 28, 2010 Room 100 Keck Center of the National Academies 500 Fifth Street, NW Washington, DC 8:30 AM Welcome and Opening Remarks David Challoner, Chair, IOM Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process 8:40 Trustworthy Medical Device Software Kevin Fu, University of Massachusetts Amherst 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 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. 10:20 Break FDA Postmarket Surveillance 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 61

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62 THE FDA 510(k) CLEARANCE PROCESS 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: 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 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 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 DELTA Surveillance Project Frederic S. Resnic, Director, Cardiac Catheterization Laboratory Brigham and Women’s Hospital, and Assistant Professor of Medicine, Harvard Medical School 3:30 Break

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63 APPENDIX A 3:40 Postmarket Surveillance of Medical Devices Panel Discussion Moderated by Lazar Greenfield, committee member Panelists: · orkshop speakers: Susan Gardner, Ralph Hall, W William H. Maisel, Frederick A. Masoudi, Eric D. Peterson, Frederic S. Resnic, and Paul D. Varosy · usan Alpert, Senior Vice President–Chief Regulatory S Officer, Medtronic Inc. · arry Kessler, Professor and Chair, Department of L Health Services, School of Public Health, University of Washington 5:30 Adjourn

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