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An Overview of FDA Medical Device Regulation as it Relates to Deep Brain Stimulation Devices

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8 Author(s)
Pea, C. ; U.S. Food and Drug Adm., Rockville ; Bowsher, K. ; Costello, A. ; De Luca, R.
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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.

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Neural Systems and Rehabilitation Engineering, IEEE Transactions on  (Volume:15 ,  Issue: 3 )