-
- Timothy Marjenin, Pamela Scott, Anita Bajaj, Tushar Bansal, Bernard Berne, Kristen Bowsher, Ann Costello, John Doucet, Eric Franca, Chandramallika Ghosh, Anupama Govindarajan, Stacie Gutowski, Katrina Gwinn, Stephen Hinckley, Erin Keegan, Hyung Lee, Binoy Mathews, Sanjay Misra, Shyama Patel, Xiaorui Tang, William Heetderks, Michael Hoffmann, and Carlos Pena.
- Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD, USA.
- Neuromodulation. 2020 Jan 1; 23 (1): 3-9.
AbstractThe United States Food and Drug Administration (FDA) ensures that patients in the United States 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, including many neuromodulation devices. This article focuses on neuromodulation devices and addresses how to navigate the FDA's regulatory landscape to successfully bring devices to patients.Published 2020. This article is a U.S. Government work and is in the public domain in the USA.
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