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

By: Institute of Medicine Board on Population Health and Public Health Practice Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process Theresa Wizemann (Author)

Ksh 5,720.00
Format :

Format(s): DRM PDF

ISBN-13: 9780309158503

Publisher: National Academies Press

Imprint: National Academies Press

Publication Date: October 4th, 2010

Country of Publication: US

Language: English

Pages: 140

Physical Edition EAN: 9780309158497

Category: Medicine , Medical equipment & techniques , Public health & preventive medicine

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  • Description

  • Author Bio

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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