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

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

Balancing Patient Safety and Innovation: Workshop Report (2010)
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Description

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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Suggested Citation

Institute of Medicine. 2010. Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report. Washington, DC: The National Academies Press. https://doi.org/10.17226/12960.

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Publication Info

140 pages | 6 x 9
ISBNs:
  • Paperback: 978-0-309-15849-7
  • Ebook: 978-0-309-16290-6
DOI: https://doi.org/10.17226/12960
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