FDA Regulation of Neurological and Physical Medicine Devices: Access to Safe and Effective Neurotechnologies for All Americans

Leigh Anderson; Patrick Antkowiak; Aden Asefa; Amber Ballard; Tushar Bansal; Ayo Bello; Bernard Berne; Kristen Bowsher; Bennett Blumenkopf; Ian Broverman; Mohamad Bydon; Kuo Chao; Peter Como; Karlene Cork; Ann Costello; Kathryn De Laurentis; Angela DeMarco; Heather Dean; John Doucet; Bradley Dworak; Lisa Epperson; Eric Franca; Naz Ghassemian; Chandramallika Ghosh; Anupama Govindarajan; Jay Gupta; Stacie Gutowski; Robert Herrmann; Michael Hoffmann; William Heetderks; Steven Hsu; Daryl Kaufman; Erin Keegan; Gregg Kittlesen; Kevin Khuu; Hyung Lee; Larry Lo; Ian Marcus; Timothy Marjenin; Binoy Mathews; Sanjay Misra; Vivek Pinto; Vesper Ramos; Samuel Raben; Avena Russell; Devjani Saha; Joonil Seog; Christian Shenouda; Myra Smith; Xiaorui Tang; Kelliann Wachrathit; Jaime Waterhouse; Dhanya Williams; Xiaolin Zheng; Carlos Peña

doi:10.1016/j.neuron.2016.10.036

FDA Regulation of Neurological and Physical Medicine Devices: Access to Safe and Effective Neurotechnologies for All Americans

Leigh Anderson, Patrick Antkowiak, Aden Asefa, Amber Ballard, Tushar Bansal, Ayo Bello, Bernard Berne, Kristen Bowsher, Bennett Blumenkopf, Ian Broverman, Mohamad Bydon, Kuo Chao, Peter Como, Karlene Cork, Ann Costello, Kathryn De Laurentis, Angela DeMarco, Heather Dean, John Doucet, Bradley DworakLisa Epperson, Eric Franca, Naz Ghassemian, Chandramallika Ghosh, Anupama Govindarajan, Jay Gupta, Stacie Gutowski, Robert Herrmann, Michael Hoffmann, William Heetderks, Steven Hsu, Daryl Kaufman, Erin Keegan, Gregg Kittlesen, Kevin Khuu, Hyung Lee, Larry Lo, Ian Marcus, Timothy Marjenin, Binoy Mathews, Sanjay Misra, Vivek Pinto, Vesper Ramos, Samuel Raben, Avena Russell, Devjani Saha, Joonil Seog, Christian Shenouda, Myra Smith, Xiaorui Tang, Kelliann Wachrathit, Jaime Waterhouse, Dhanya Williams, Xiaolin Zheng, Carlos Peña

Research output: Contribution to journal › Short survey › peer-review

8 Scopus citations

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.

Original language	English (US)
Pages (from-to)	943-948
Number of pages	6
Journal	Neuron
Volume	92
Issue number	5
DOIs	https://doi.org/10.1016/j.neuron.2016.10.036
State	Published - Dec 7 2016
Externally published	Yes

ASJC Scopus subject areas

Neuroscience(all)

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10.1016/j.neuron.2016.10.036

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Anderson, L., Antkowiak, P., Asefa, A., Ballard, A., Bansal, T., Bello, A., Berne, B., Bowsher, K., Blumenkopf, B., Broverman, I., Bydon, M., Chao, K., Como, P., Cork, K., Costello, A., De Laurentis, K., DeMarco, A., Dean, H., Doucet, J., ... Peña, C. (2016). FDA Regulation of Neurological and Physical Medicine Devices: Access to Safe and Effective Neurotechnologies for All Americans. Neuron, 92(5), 943-948. https://doi.org/10.1016/j.neuron.2016.10.036

Anderson, L, Antkowiak, P, Asefa, A, Ballard, A, Bansal, T, Bello, A, Berne, B, Bowsher, K, Blumenkopf, B, Broverman, I, Bydon, M, Chao, K, Como, P, Cork, K, Costello, A, De Laurentis, K, DeMarco, A, Dean, H, Doucet, J, Dworak, B, Epperson, L, Franca, E, Ghassemian, N, Ghosh, C, Govindarajan, A, Gupta, J, Gutowski, S, Herrmann, R, Hoffmann, M, Heetderks, W, Hsu, S, Kaufman, D, Keegan, E, Kittlesen, G, Khuu, K, Lee, H, Lo, L, Marcus, I, Marjenin, T, Mathews, B, Misra, S, Pinto, V, Ramos, V, Raben, S, Russell, A, Saha, D, Seog, J, Shenouda, C, Smith, M, Tang, X, Wachrathit, K, Waterhouse, J, Williams, D, Zheng, X & Peña, C 2016, 'FDA Regulation of Neurological and Physical Medicine Devices: Access to Safe and Effective Neurotechnologies for All Americans', Neuron, vol. 92, no. 5, pp. 943-948. https://doi.org/10.1016/j.neuron.2016.10.036

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AU - Berne, Bernard

AU - Bowsher, Kristen

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AU - Ghosh, Chandramallika

AU - Govindarajan, Anupama

AU - Gupta, Jay

AU - Gutowski, Stacie

AU - Herrmann, Robert

AU - Hoffmann, Michael

AU - Heetderks, William

AU - Hsu, Steven

AU - Kaufman, Daryl

AU - Keegan, Erin

AU - Kittlesen, Gregg

AU - Khuu, Kevin

AU - Lee, Hyung

AU - Lo, Larry

AU - Marcus, Ian

AU - Marjenin, Timothy

AU - Mathews, Binoy

AU - Misra, Sanjay

AU - Pinto, Vivek

AU - Ramos, Vesper

AU - Raben, Samuel

AU - Russell, Avena

AU - Saha, Devjani

AU - Seog, Joonil

AU - Shenouda, Christian

AU - Smith, Myra

AU - Tang, Xiaorui

AU - Wachrathit, Kelliann

AU - Waterhouse, Jaime

AU - Williams, Dhanya

AU - Zheng, Xiaolin

AU - Peña, Carlos

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FDA Regulation of Neurological and Physical Medicine Devices: Access to Safe and Effective Neurotechnologies for All Americans

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