Public health effectiveness of the FDA 510(k) clearance process : balancing patient safety and innovation : workshop report

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. 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. 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. Includes Bibliographical References. Also Issued Online. Mode Of Access: World Wide Web. "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."-- Source other than Library of Congress "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