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

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  • 1Office of the Commissioner, U.S. Food and Drug Administration, Rockville, MD 20857, USA carlos.pena@fda.hhs.gov

Abstract

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.

[PubMed - indexed for MEDLINE]
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