Welcome and Opening Remarks - Legislative History of the Medical Device Amendments of 1976

David Challoner, Chair, IOM Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
Peter Barton Hutt, Covington & Burling, LLP

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)

FDA’s Compliance Infrastructure

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

Structure of the Medical Device Industry Innovation Ecosystem

Josh Makower, Consulting Associate Professor of Medicine, Stanford University Biodesign Program, and Founder & 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 2 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

Welcome - Comparative Overview of Medical Device Regulatory Systems

David Challoner, Chair, IOM Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
David Jefferys, Senior Vice President, Global Regulatory, Healthcare Policy Department, Eisai Europe Ltd

Past, Present and Future of Global Harmonization

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

Update on PWC’s Medical Innovation Technology Score Card

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

The Global Regulatory Environment Panel Discussion

Moderated by Kathryn Zoon, Committee Member
Panelists:
• David Jefferys, Janet Trunzo and Doug Mowen