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This paper reviews the FDA's premarket and postmarket regulatory requirements as they relate to deep brain stimulation devices, from device classification and clinical studies to final marketing.
This paper provides an overview of FDA premarket and postmarket regulatory requirements for deep brain stimulation devices.
Clinicians should verify FDA compliance for DBS devices; review extends regulatory context for device researchers.
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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Peña et al. (2007) conducted a review in Deep brain stimulation devices. FDA medical device regulation was evaluated. This paper reviews the FDA's premarket and postmarket regulatory requirements as they relate to deep brain stimulation devices, from device classification and clinical studies to final marketing.
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