The United States Food and Drug Administration (FDA) ensures that patients in the United States have access to safe and effective medical devices. The division of neurological and physical medicine devices reviews medical technologies that interface with the nervous system, including many neuromodulation devices. This article focuses on neuromodulation devices and addresses how to navigate the FDA's regulatory landscape to successfully bring devices to patients.
Keywords: Deep brain stimulation; implant; neurostimulation; noninvasive; regulation; spinal cord stimulation; transcranial magnetic stimulation; vagal nerve stimulation.
Published 2020. This article is a U.S. Government work and is in the public domain in the USA.