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DOI 10.1016/j.neuron.2016.10.036

Медицинская библиотека · Neuron · 2016

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, Wachrathit Kelliann, Waterhouse Jaime, Williams Dhanya, Zheng Xiaolin, Peña Carlos

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Аннотация

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.

Для цитирования: 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, Wachrathit Kelliann, Waterhouse Jaime, Williams Dhanya, Zheng Xiaolin, Peña Carlos. FDA Regulation of Neurological and Physical Medicine Devices: Access to Safe and Effective Neurotechnologies for All Americans.. Neuron. 2016. DOI: 10.1016/j.neuron.2016.10.036.

Предметные рубрики MeSH

Device ApprovalDysphoniaEquipment and SuppliesHealth Services AccessibilityHumansPhysical and Rehabilitation MedicineUnited StatesUnited States Food and Drug Administration
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