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.
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.