Research Catalog

Title

Public health effectiveness of the FDA 510(k) clearance process : balancing patient safety and innovation : workshop report / Theresa Wizemann, editor ; Committee on the Public Health Effectiveness of the FDA 510(k) clearance process, Board on Population Health and Public Health Practice, Institute of Medicine of the National Academies.

Publication

Washington, D.C. : National Academies Press, [2010], ©2010.

Items in the Library & Off-site

Details

Additional Authors

• Institute of Medicine (U.S.). Board on Population Health and Public Health Practice, author. http://id.loc.gov/authorities/names/no2005081654
• Institute of Medicine (U.S.). Committee on the Public Health Effectiveness of the FDA 510(k) clearance process, Board on Population Health and Public Health Practice, author.
• Wizemann, Theresa M.

Description

xii, 128 pages : illustrations (some color); 23 cm.

Summary

"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."--resource home page.

Alternative Title

FDA 510(k) clearance process

Subject

• Public health > Standards > United States > Congresses
• Public health > United States > Congresses
• United States. Food and Drug Administration

Bibliography (note)

• Includes bibliographical references.

Contents

Introduction -- Legislative history of the Medical Device Amendments of 1976 -- Premarket notification -- The medical device industry innovation ecosystem -- The global framework for regulation of medical devices -- Public comments.

ISBN

• 9780309158497
• 0309158494

Owning Institutions

Princeton University Library