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Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing patient Safety and Innovation - Workshop Report
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
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
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
Public Comment—Registered Speakers
Recess Tuesday, June 15, 2010
Chair, IOM Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
Comparative Overview of Medical Device Regulatory Systems
David Jefferys, Senior Vice President, Global Regulatory, Healthcare Policy Department, Eisai Europe Ltd.