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

Autor: Tushar Bansal, Daryl Kaufman, Angela DeMarco, Kelliann Wachrathit, Heather Dean, Bradley Dworak, Ian Marcus, Bennett Blumenkopf, Avena Russell, Vesper Fe Marie Llaneza Ramos, Steven Hsu, Jaime Waterhouse, Robert Herrmann, Myra Smith, Samuel Raben, Stacie Gutowski, Hyung Lee, A.V. Govindarajan, Carlos Peña, Kathryn De Laurentis, Binoy Mathews, Xiaorui Tang, John Doucet, Amber Ballard, Peter Como, Karlene Cork, Xiaolin Zheng, Erin Keegan, Dhanya Williams, Ayo Bello, Kevin Khuu, Ian Broverman, Jay Gupta, William Heetderks, Ann Costello, Naz Ghassemian, Kristen Bowsher, Gregg Kittlesen, Devjani Saha, Christian Shenouda, Bernard Berne, Joonil Seog, Larry Lo, Mohamad Bydon, Timothy Marjenin, Aden Asefa, Kuo Chao, Patrick Antkowiak, Vivek Pinto, Michael Hoffmann, Leigh Anderson, Lisa Epperson, Chandramallika Ghosh, Sanjay Misra, Eric Franca
Rok vydání: 2016
Předmět:
Zdroj: Neuron. 92(5)
ISSN: 1097-4199
Popis: 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.
Databáze: OpenAIRE