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

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

Balancing Patient Safety and Innovation

Workshop Report

; Editor: Theresa Wizemann.

Washington (DC): National Academies Press (US); .
ISBN-13: 978-0-309-15849-7ISBN-10: 0-309-15849-4

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.

Contents

Suggested citation:

IOM (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.

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.

This project was supported by a contract between the National Academy of Sciences and the US Department of Health and Human Services (HH5F223200810020I, TO#13). Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the views of the agency that provided support for this project.

Copyright 2010 by the National Academy of Sciences. All rights reserved.
Bookshelf ID: NBK209791PMID: 24983045DOI: 10.17226/12960

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