Title :
An Overview of FDA Medical Device Regulation as it Relates to Deep Brain Stimulation Devices
Author :
Peña, Carlos ; Bowsher, Kristen ; Costello, Ann ; De Luca, Robert ; Doll, Sara ; Li, Khan ; Schroeder, Marie ; Stevens, Theodore
Author_Institution :
U.S. Food and Drug Adm., Rockville
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.
Keywords :
biomedical equipment; brain; health and safety; health care; FDA medical device regulation; deep brain stimulation devices; medical products; postmarket regulation; premarket regulation; Deep brain stimulation (DBS); Food and Drug Administration (FDA); medical devices; Deep Brain Stimulation; Device Approval; Guidelines as Topic; Product Surveillance, Postmarketing; United States; United States Food and Drug Administration;
Journal_Title :
Neural Systems and Rehabilitation Engineering, IEEE Transactions on
DOI :
10.1109/TNSRE.2007.903973