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IEEE Trans Neural Syst Rehabil Eng · Sep 2007
ReviewAn overview of FDA medical device regulation as it relates to deep brain stimulation devices.
- Carlos Peña, Kristen Bowsher, Ann Costello, Robert De Luca, Sara Doll, Khan Li, Marie Schroeder, and Theodore Stevens.
- Office of the Commissioner, U.S. Food and Drug Administration, Rockville, MD 20857, USA carlos.pena@fda.hhs.gov
- IEEE Trans Neural Syst Rehabil Eng. 2007 Sep 1;15(3):421-4.
AbstractThe 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.
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