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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.
Afiliação
  • 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 em En | MEDLINE | ID: mdl-27930909
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.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: United States Food and Drug Administration / Aprovação de Equipamentos / Equipamentos e Provisões / Acessibilidade aos Serviços de Saúde Aspecto: Determinantes_sociais_saude Limite: Humans País/Região como assunto: America do norte Idioma: En Revista: Neuron Assunto da revista: NEUROLOGIA Ano de publicação: 2016 Tipo de documento: Article País de afiliação: Estados Unidos
Texto completo
Adicionar na Minha BVS
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XML
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Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: United States Food and Drug Administration / Aprovação de Equipamentos / Equipamentos e Provisões / Acessibilidade aos Serviços de Saúde Aspecto: Determinantes_sociais_saude Limite: Humans País/Região como assunto: America do norte Idioma: En Revista: Neuron Assunto da revista: NEUROLOGIA Ano de publicação: 2016 Tipo de documento: Article País de afiliação: Estados Unidos