An overview of FDA medical device regulation as it relates to deep brain stimulation devices

被引：22
|
作者：
Pena, Carlos [1 ]
Bowsher, Kristen
Costello, Ann
De Luca, Robert
Doll, Sara
Li, Khan
Schroeder, Marie
Stevens, Theodore
机构：
[1] US FDA, Off Commissioner, Rockville, MD 20857 USA
[2] US FDA, Ctr Devices & Radiol Hlth, Rockville, MD 20857 USA
[3] Johns Hopkins Univ, Baltimore, MD 21205 USA
来源：
IEEE TRANSACTIONS ON NEURAL SYSTEMS AND REHABILITATION ENGINEERING | 2007年 / 15卷 / 03期
关键词：
deep brain stimulation (DBS); food and drug; administration (FDA); medical devices;
D O I：
10.1109/TNSRE.2007.903973
中图分类号：
R318 [生物医学工程];
学科分类号：
0831 ;
摘要：
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.
引用
收藏
页码：421 / 424
页数：4
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