title: An overview of FDA medical device regulation as it relates to deep brain stimulation devices.
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.
authors: Office of the Commissioner, U.S. Food and Drug Administration, Rockville, MD 20857, USA carlos.pena@fda.hhs.gov
authors: Carlos
authors: C
authors: Peña
authors: Kristen
authors: K
authors: Bowsher
authors: Ann
authors: A
authors: Costello
authors: Robert
authors: R
authors: De Luca
authors: Sara
authors: S
authors: Doll
authors: Khan
authors: K
authors: Li
authors: Marie
authors: M
authors: Schroeder
authors: Theodore
authors: T
authors: Stevens
mesh_terms: D046690:Deep Brain Stimulation / Q000295:instrumentation* / Q000592:standards*; D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards; D017408:Guidelines as Topic; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence* / Q000592:standards