Balancing Patient Safety and Innovation: Workshop Report (2010)
Table of Contents
Theresa Wizemann, Editor; Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process; Institute of Medicine
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.
National Research Council. Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report. Washington, DC: The National Academies Press, 2010.