. "Appendix A: Workshop Agenda." Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report. Washington, DC: The National Academies Press, 2010.
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Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing patient Safety and Innovation - Workshop Report
11:10
Structure of the Medical Device Industry InnovationEcosystem
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 DeviceDevelopment 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 InnovationPanel 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 RegulatorySystems
David Jefferys, Senior Vice President, Global Regulatory, Healthcare Policy Department, Eisai Europe Ltd.
