Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report

Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process,Institute of Medicine

Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report
Format
Paperback
Publisher
National Academies Press
Country
United States
Published
15 October 2010
Pages
140
ISBN
9780309158497

Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report

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.

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