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

Author:

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

Publisher

Elsevier BV

Subject

General Neuroscience

Reference28 articles.

1. Brain–computer interface devices for patients with paralysis and amputation: a meeting report

2. CFR (Code of Federal Regulations) (2016). http://www.ecfr.gov/cgi-bin/text-idx?SID=0457f6b5a4685adc20042bc29d13a9c9&mc=true&node=pt21.8.812&rgn=div5.

3. Food and Drug Administration (2006). http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126418.pdf.

4. Food and Drug Administration (2013a). http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm082535.htm.

5. Food and Drug Administration (2013b). http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm125520.htm.

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