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Update to Food and Drug Administration Regulation of Stroke Neurological Devices.

According to the National Institute of Neurological Disorders and Stroke, the cost of stroke to the United States is staggering and medical devices have a key role in addressing and ameliorating this condition. For example, the total cost of stroke to the United States is estimated at about $43 billion/y; a direct cost for medical care and therapy estimated at about $28 billion/y, and indirect costs from lost productivity and other factors estimated at about $15 billion/y. The US Food and Drug Administration (FDA) regulates a variety of products including foods, drugs, biologics, medical devices, cosmetics, veterinary products, and tobacco products. Medical devices represent an important technology sector that can address the burden of many diseases. Neurological devices address several life-threatening conditions such as cerebrovascular disease, including acute ischemic stroke (AIS). The Center for Devices and Radiological Health (CDRH), a core component of FDA, is committed to fostering the development of high-quality, safe, and effective medical devices of public health importance and to facilitating greater patient access to these technologies. Enabling new treatments to reach the marketplace requires valid scientific evidence and a regulatory process that can accelerate promising new treatments. This process is critical to alleviating the heavy disease burden of stroke in the United States. This article reviews medical device regulation, premarket and postmarket evaluation of devices indicated for stroke and cerebrovascular disease and provides a staff perspective on the future development of these devices.