An overview of FDA medical device regulation as it relates to deep brain stimulation devices.
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.
Peña
Carlos
C
Office of the Commissioner, U.S. Food and Drug Administration, Rockville, MD 20857, USA carlos.pena@fda.hhs.gov
Bowsher
Kristen
K
Costello
Ann
A
De Luca
Robert
R
Doll
Sara
S
Li
Khan
K
Schroeder
Marie
M
Stevens
Theodore
T
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