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



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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 6

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6 THE FDA 510(k) ClEARANCE PROCESS 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.

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65 APPENDIX A 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 1This presentation was given by Janet Trunzo on behalf of Doug Mowen, who was unexpect- edly unable to attend the workshop.

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