Public Health Effectiveness of the FDA 510(k) Clearance Process

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. Table of Contents Front Matter 1 Introduction 2 Legislative History of the Medical Device Amendments of 1976 3 Premarket Notification 4 The Medical Device Industry Innovation Ecosystem 5 The Global Framework for Regulation of Medical Devices 6 Public Comments Appendix A: Workshop Agenda Appendix B: Biographic Information on Invited Speakers, Panelists, and Authors of Commissioned Papers Appendix C: Premarket Notification: A Key Element of US Medical Device Regulation--Larry Kessler and Philip J. Phillips Appendix D: Impact of the Regulatory Framework on Medical Device Development and Innovation--David W. Feigal, Jr.