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Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2010. Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/12960.
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Appendix A
Workshop Agenda

Hotel Monaco

Paris Ballroom

700 F Street, NW

Washington, DC 20004


Monday, June 14, 2010

8:30 AM

Welcome and Opening Remarks

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

8:50

Legislative History of the Medical Device Amendments of 1976

Peter Barton Hutt, Covington & Burling, LLP

9:30

Premarket Notification: A Key Element of US Medical Device Regulation

Philip J. Phillips, PCG, LLC

Larry Kessler, University of Washington, School of Public Health (coauthor)

10:10

Break

10:30

FDA’s Compliance Infrastructure

Timothy A. Ulatowski, Director, Office of Compliance, Center for Devices and Radiological Health, FDA

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2010. Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/12960.
×

11:10

Structure of the Medical Device Industry Innovation Ecosystem

Josh Makower, Consulting Associate Professor of Medicine, Stanford University Biodesign Program, and Founder and CEO, ExploraMed Development, LLC

12:00 PM

Lunch

1:30

Impact of the Regulatory Framework on Medical Device Development and Innovation

David W. Feigal, Jr., Vice President, Global Regulatory, Amgen, and Associate Faculty, Arizona State University School of Law

2:10

Balancing Patient Safety and Innovation Panel Discussion

Moderated by William Vodra, Committee Member Panelists:

  • Workshop speakers: David W. Feigal, Jr., Peter Barton Hutt, Josh Makower, Philip Phillips, and Tim Ulatowski

  • Amy Allina, Program and Policy Director, National Women’s Health Network

  • D. Bruce Burlington, Independent Consultant

  • William Vaughan, Consultant, Consumer’s Union

3:00

Break

3:15

Public Comment—Registered Speakers

5:30

Recess

Tuesday, June 15, 2010

8:30 AM

Welcome

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

8:40

Comparative Overview of Medical Device Regulatory Systems

David Jefferys, Senior Vice President, Global Regulatory, Healthcare Policy Department, Eisai Europe Ltd.

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2010. Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/12960.
×

9:20

Past, Present and Future of Global Harmonization

Janet Trunzo, Executive Vice President, Technology & Regulatory Affairs, Advanced Medical Technology Association (AdvaMed)

10:00

Update on PWC’s Medical Innovation Technology Score Card

Doug Mowen,1 Managing Director, Medical Device Industry Practice, PricewaterhouseCoopers

10:40

Break

10:50

The Global Regulatory Environment Panel Discussion

Moderated by Kathryn Zoon, Committee Member Panelists:

  • David W. Feigal, Jr., David Jefferys, and Janet Trunzo

11:30

Public Comment—Registered Speakers

12:30 PM

Adjourn

1

This presentation was given by Janet Trunzo on behalf of Doug Mowen, who was unexpectedly unable to attend the workshop.

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2010. Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/12960.
×

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Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2010. Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/12960.
×
Page 63
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2010. Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/12960.
×
Page 64
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2010. Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/12960.
×
Page 65
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2010. Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/12960.
×
Page 66
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 assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.

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