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FDA Regulation of Neurological and Physical Medicine Devices: Access to Safe and Effective Neurotechnologies for All Americans.
Anderson, Leigh; Antkowiak, Patrick; Asefa, Aden; Ballard, Amber; Bansal, Tushar; Bello, Ayo; Berne, Bernard; Bowsher, Kristen; Blumenkopf, Bennett; Broverman, Ian; Bydon, Mohamad; Chao, Kuo; Como, Peter; Cork, Karlene; Costello, Ann; De Laurentis, Kathryn; DeMarco, Angela; Dean, Heather; Doucet, John; Dworak, Bradley; Epperson, Lisa; Franca, Eric; Ghassemian, Naz; Ghosh, Chandramallika; Govindarajan, Anupama; Gupta, Jay; Gutowski, Stacie; Herrmann, Robert; Hoffmann, Michael; Heetderks, William; Hsu, Steven; Kaufman, Daryl; Keegan, Erin; Kittlesen, Gregg; Khuu, Kevin; Lee, Hyung; Lo, Larry; Marcus, Ian; Marjenin, Timothy; Mathews, Binoy; Misra, Sanjay; Pinto, Vivek; Ramos, Vesper; Raben, Samuel; Russell, Avena; Saha, Devjani; Seog, Joonil; Shenouda, Christian; Smith, Myra; Tang, Xiaorui.
Affiliation
  • Anderson L; 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.
  • Antkowiak P; 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.
  • Asefa A; 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.
  • Ballard A; 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.
  • Bansal T; 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.
  • Bello A; 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.
  • Berne B; 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.
  • Bowsher K; 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.
  • Blumenkopf B; 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.
  • Broverman I; 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.
  • Bydon M; 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.
  • Chao K; 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.
  • Como P; 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.
  • Cork K; 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.
  • Costello A; 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.
  • De Laurentis K; 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.
  • DeMarco A; 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.
  • Dean H; 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.
  • Doucet J; 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.
  • Dworak B; 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.
  • Epperson L; 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.
  • Franca E; 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.
  • Ghassemian N; 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.
  • Ghosh C; 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.
  • Govindarajan A; 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.
  • Gupta J; 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.
  • Gutowski S; 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.
  • Herrmann R; 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.
  • Hoffmann M; 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.
  • Heetderks W; 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.
  • Hsu S; 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.
  • Kaufman D; 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.
  • Keegan E; 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.
  • Kittlesen G; 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.
  • Khuu K; 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.
  • Lee H; 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.
  • Lo L; 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.
  • Marcus I; 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.
  • Marjenin T; 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.
  • Mathews B; 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.
  • Misra S; 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.
  • Pinto V; 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.
  • Ramos V; 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.
  • Raben S; 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.
  • Russell A; 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.
  • Saha D; 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.
  • Seog J; 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.
  • Shenouda C; 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.
  • Smith M; 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.
  • Tang X; 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.
Neuron ; 92(5): 943-948, 2016 Dec 07.
Article in En | MEDLINE | ID: mdl-27930909

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: United States Food and Drug Administration / Device Approval / Equipment and Supplies / Health Services Accessibility Aspects: Determinantes_sociais_saude Limits: Humans Country/Region as subject: America do norte Language: En Journal: Neuron Journal subject: NEUROLOGIA Year: 2016 Document type: Article Affiliation country: United States Country of publication: United States

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: United States Food and Drug Administration / Device Approval / Equipment and Supplies / Health Services Accessibility Aspects: Determinantes_sociais_saude Limits: Humans Country/Region as subject: America do norte Language: En Journal: Neuron Journal subject: NEUROLOGIA Year: 2016 Document type: Article Affiliation country: United States Country of publication: United States