美国食品药品监督管理局（FDA）与脑深部电刺激设备相关的医疗器械监管概述。
An overview of FDA medical device regulation as it relates to deep brain stimulation devices.
作者信息
Peña Carlos, Bowsher Kristen, Costello Ann, De Luca Robert, Doll Sara, Li Khan, Schroeder Marie, Stevens Theodore
机构信息
Office of the Commissioner, U.S. Food and Drug Administration, Rockville, MD 20857, USA
出版信息
IEEE Trans Neural Syst Rehabil Eng. 2007 Sep;15(3):421-4. doi: 10.1109/TNSRE.2007.903973.
The United States Food and Drug Administration (FDA) is charged with assuring the safety and effectiveness of a variety of medical products and the FDA's Center for Devices and Radiological Health is responsible for premarket and postmarket regulation of medical devices. In this paper, we review--from device classification and clinical studies to the final marketing application--FDA's premarket requirements and postmarket requirements as they relate to deep brain stimulation devices.
美国食品药品监督管理局（FDA）负责确保各类医疗产品的安全性和有效性，FDA的器械与放射健康中心负责医疗器械上市前和上市后的监管。在本文中，我们将从器械分类、临床研究到最终的上市申请，回顾FDA与脑深部电刺激器械相关的上市前要求和上市后要求。
Zotero 插件