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, Sheng-fu 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 journalShort survey

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 languageEnglish (US)
Pages (from-to)943-948
Number of pages6
JournalNeuron
Volume92
Issue number5
DOIs
StatePublished - Dec 7 2016
Externally publishedYes

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Physical and Rehabilitation Medicine
Drug and Narcotic Control
United States Food and Drug Administration
Equipment and Supplies
Nervous System
Technology

ASJC Scopus subject areas

  • Neuroscience(all)

Cite this

Anderson, L., Antkowiak, P., Asefa, A., Ballard, A., Bansal, T., Bello, A., ... 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

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, Sheng-fu; 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.

In: Neuron, Vol. 92, No. 5, 07.12.2016, p. 943-948.

Research output: Contribution to journalShort survey

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, S, 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
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, Sheng-fu ; 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. In: Neuron. 2016 ; Vol. 92, No. 5. pp. 943-948.
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