title: FDA Regulation of Neurological and Physical Medicine Devices: Access to Safe and Effective Neurotechnologies for All Americans.
abstract: 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.
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Leigh
authors.initials: L
authors.lastname: Anderson
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Patrick
authors.initials: P
authors.lastname: Antkowiak
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Aden
authors.initials: A
authors.lastname: Asefa
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Amber
authors.initials: A
authors.lastname: Ballard
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Tushar
authors.initials: T
authors.lastname: Bansal
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Ayo
authors.initials: A
authors.lastname: Bello
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Bernard
authors.initials: B
authors.lastname: Berne
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Kristen
authors.initials: K
authors.lastname: Bowsher
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Bennett
authors.initials: B
authors.lastname: Blumenkopf
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Ian
authors.initials: I
authors.lastname: Broverman
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Mohamad
authors.initials: M
authors.lastname: Bydon
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Kuo
authors.initials: K
authors.lastname: Chao
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Peter
authors.initials: P
authors.lastname: Como
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Karlene
authors.initials: K
authors.lastname: Cork
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Ann
authors.initials: A
authors.lastname: Costello
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Kathryn
authors.initials: K
authors.lastname: De Laurentis
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Angela
authors.initials: A
authors.lastname: DeMarco
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Heather
authors.initials: H
authors.lastname: Dean
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: John
authors.initials: J
authors.lastname: Doucet
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Bradley
authors.initials: B
authors.lastname: Dworak
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Lisa
authors.initials: L
authors.lastname: Epperson
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Eric
authors.initials: E
authors.lastname: Franca
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Naz
authors.initials: N
authors.lastname: Ghassemian
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Chandramallika
authors.initials: C
authors.lastname: Ghosh
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Anupama
authors.initials: A
authors.lastname: Govindarajan
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Jay
authors.initials: J
authors.lastname: Gupta
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Stacie
authors.initials: S
authors.lastname: Gutowski
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Herrmann
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Hoffmann
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: William
authors.initials: W
authors.lastname: Heetderks
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Steven
authors.initials: S
authors.lastname: Hsu
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Daryl
authors.initials: D
authors.lastname: Kaufman
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Erin
authors.initials: E
authors.lastname: Keegan
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Gregg
authors.initials: G
authors.lastname: Kittlesen
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Kevin
authors.initials: K
authors.lastname: Khuu
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Hyung
authors.initials: H
authors.lastname: Lee
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Larry
authors.initials: L
authors.lastname: Lo
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Ian
authors.initials: I
authors.lastname: Marcus
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Timothy
authors.initials: T
authors.lastname: Marjenin
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Binoy
authors.initials: B
authors.lastname: Mathews
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Sanjay
authors.initials: S
authors.lastname: Misra
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Vivek
authors.initials: V
authors.lastname: Pinto
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Vesper
authors.initials: V
authors.lastname: Ramos
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Samuel
authors.initials: S
authors.lastname: Raben
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Avena
authors.initials: A
authors.lastname: Russell
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Devjani
authors.initials: D
authors.lastname: Saha
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Joonil
authors.initials: J
authors.lastname: Seog
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Christian
authors.initials: C
authors.lastname: Shenouda
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Myra
authors.initials: M
authors.lastname: Smith
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Xiaorui
authors.initials: X
authors.lastname: Tang
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Kelliann
authors.initials: K
authors.lastname: Wachrathit
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Jaime
authors.initials: J
authors.lastname: Waterhouse
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Dhanya
authors.initials: D
authors.lastname: Williams
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors.forename: Xiaolin
authors.initials: X
authors.lastname: Zheng
authors.affiliation: Division of Neurological and Physical Medicine Devices, Office of Device Evaluation, Center for Devices and Radiological Health, United States Food and Drug Administration, Room 2680, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA. Electronic address: carlos.pena@fda.hhs.gov.
authors.forename: Carlos
authors.initials: C
authors.lastname: Peña
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D055154:Dysphonia; D004864:Equipment and Supplies; D006297:Health Services Accessibility; D006801:Humans; D010810:Physical and Rehabilitation Medicine; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*