ABSTRACT
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.
Subject(s)
Device Approval/legislation & jurisprudence , Device Approval/standards , Implantable Neurostimulators/standards , Transcutaneous Electric Nerve Stimulation/standards , Humans , Transcutaneous Electric Nerve Stimulation/instrumentation , United StatesABSTRACT
The United States Food and Drug Administration (FDA) ensures that patients in the U.S. 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. This article addresses how to navigate the FDA's regulatory landscape to successfully bring medical devices to patients.
