1.
Stroke
; 50(2): 524-528, 2019 02.
Article
in English
| MEDLINE
| ID: mdl-30661499
Subject(s)
Brain Ischemia , Equipment and Supplies , Stroke , Brain Ischemia/economics , Brain Ischemia/therapy , Costs and Cost Analysis , Equipment and Supplies/economics , Equipment and Supplies/standards , Humans , Medical Device Legislation/economics , Medical Device Legislation/standards , Medical Device Legislation/trends , Stroke/economics , Stroke/therapy , United States , United States Food and Drug Administration
2.
Neuron
; 92(5): 943-948, 2016 Dec 07.
Article
in English
| MEDLINE
| ID: mdl-27930909
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.
