FDA Perspectives on the Regulation of Neuromodulation Devices

Autor:	Anita Bajaj, Kristen Bowsher, A.V. Govindarajan, Carlos Peña, Pamela D. Scott, Tushar Bansal, Binoy Mathews, Hyung Lee, Michael Hoffmann, Bernard Berne, Timothy Marjenin, Sanjay Misra, Katrina Gwinn, Shyama Patel, Erin Keegan, Chandramallika Ghosh, Eric Franca, William Heetderks, Ann Costello, Xiaorui Tang, Stephen Hinckley, Stacie Gutowski, John Doucet
Rok vydání:	2019
Předmět:	Nervous system Deep brain stimulation business.industry medicine.medical_treatment General Medicine Spinal cord stimulation Neuromodulation (medicine) United States Food and drug administration Transcranial magnetic stimulation 03 medical and health sciences 0302 clinical medicine Anesthesiology and Pain Medicine medicine.anatomical_structure Implantable Neurostimulators Neurology medicine Device Approval Transcutaneous Electric Nerve Stimulation Humans Neurology (clinical) business Neurostimulation Neuroscience 030217 neurology & neurosurgery
Zdroj:	Neuromodulation : journal of the International Neuromodulation SocietyREFERENCES. 23(1)
ISSN:	1525-1403
Popis:	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.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9a2b28efb4dfdf6c4f74480dca480902 https://pubmed.ncbi.nlm.nih.gov/31965667 Zobrazit plný text záznamu Full Text from ScienceDirect Plný text