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FDA Perspectives on the Regulation of Neuromodulation Devices.
Marjenin, Timothy; Scott, Pamela; Bajaj, Anita; Bansal, Tushar; Berne, Bernard; Bowsher, Kristen; Costello, Ann; Doucet, John; Franca, Eric; Ghosh, Chandramallika; Govindarajan, Anupama; Gutowski, Stacie; Gwinn, Katrina; Hinckley, Stephen; Keegan, Erin; Lee, Hyung; Mathews, Binoy; Misra, Sanjay; Patel, Shyama; Tang, Xiaorui; Heetderks, William; Hoffmann, Michael; Pena, Carlos.
Afiliação
  • Marjenin T; Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD, USA.
  • Scott P; Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD, USA.
  • Bajaj A; Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD, USA.
  • Bansal T; Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD, USA.
  • Berne B; Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD, USA.
  • Bowsher K; Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD, USA.
  • Costello A; Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD, USA.
  • Doucet J; Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD, USA.
  • Franca E; Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD, USA.
  • Ghosh C; Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD, USA.
  • Govindarajan A; Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD, USA.
  • Gutowski S; Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD, USA.
  • Gwinn K; Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD, USA.
  • Hinckley S; Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD, USA.
  • Keegan E; Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD, USA.
  • Lee H; Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD, USA.
  • Mathews B; Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD, USA.
  • Misra S; Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD, USA.
  • Patel S; Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD, USA.
  • Tang X; Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD, USA.
  • Heetderks W; Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD, USA.
  • Hoffmann M; Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD, USA.
  • Pena C; Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD, USA.
Neuromodulation ; 23(1): 3-9, 2020 Jan.
Article em En | MEDLINE | ID: mdl-31965667
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.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Estimulação Elétrica Nervosa Transcutânea / Aprovação de Equipamentos / Neuroestimuladores Implantáveis Tipo de estudo: Prognostic_studies Limite: Humans País/Região como assunto: America do norte Idioma: En Revista: Neuromodulation Ano de publicação: 2020 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Estimulação Elétrica Nervosa Transcutânea / Aprovação de Equipamentos / Neuroestimuladores Implantáveis Tipo de estudo: Prognostic_studies Limite: Humans País/Região como assunto: America do norte Idioma: En Revista: Neuromodulation Ano de publicação: 2020 Tipo de documento: Article