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Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. 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. doi: 10.17226/13020.
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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

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. 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. doi: 10.17226/13020.
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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

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. 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. doi: 10.17226/13020.
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3:40

Postmarket Surveillance of Medical Devices Panel Discussion

Moderated by Lazar Greenfield, committee member Panelists:

  • Workshop speakers: Susan Gardner, Ralph Hall, William H. Maisel, Frederick A. Masoudi, Eric D. Peterson, Frederic S. Resnic, and Paul D. 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

5:30

Adjourn

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. 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. doi: 10.17226/13020.
×

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Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. 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. doi: 10.17226/13020.
×
Page 61
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. 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. doi: 10.17226/13020.
×
Page 62
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. 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. doi: 10.17226/13020.
×
Page 63
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2011. 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. doi: 10.17226/13020.
×
Page 64
Next: Appendix B: Biographic Information on Invited Speakers, Panelists, and Authors of Commissioned Papers »
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The Food and Drug Administration (FDA) is responsible for ensuring that medical devices are safe and effective before they go on the market. Section 510(k) of the Federal Food, Drug, and Cosmetic Act requires a manufacturer of medical devices to notify FDA of its intent to market a medical device at least 90 days in advance. That window of time allows FDA to evaluate whether the device is substantially equivalent to a product already legally on the market (called a predicate), in which case the device does not need to go through the premarket approval (PMA) process.

As part of its assessment of the FDA's premarket clearance process for medical devices, the Institute of Medicine (IOM) held a workshop on July 28, 2010 to discuss how medical devices are monitored for safety after they are available to consumers. Its primary focus was on monitoring the safety of marketed medical devices, including FDA's postmarket surveillance activities, analysis of safety concerns that resulted in medical device recalls, and non-FDA sources of adverse-event information.

Public Health Effectiveness of the FDA 501(K) Clearance Process summarizes the views of the workshop participants.

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