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

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

by InstituteofMedicine (Author), TheresaWizemann (Editor), Committeeonthe Public Health Effectivenessofthe F (Author)

Synopsis

"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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Format: Paperback
Pages: 140
Publisher: National Academies Press
Published: 04 Oct 2010

ISBN 10: 0309158494
ISBN 13: 9780309158497