An Overview of the Investigational Device Exemption Regulation
Gatling, Robert R., Jr.
DIABETES CARE 5(3): 282-283, May-June 1982
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Misuse of the FDA's Humanitarian Device Exemption in Deep Brain Stimulation for Obsessive-Compulsive Disorder Fins, Joseph J; Mayberg, Helen S; Nuttin, Bart; Kubu, Cynthia S; Galert, Thorsten; Sturm, Volker; Stoppenbrink, Katja; Merkel, Reinhard; Schlaepfer, Thomas E (2011-02)Deep brain stimulation-a novel surgical procedure-is emerging as a treatment of last resort for people diagnosed with neuropsychiatric disorders such as severe obsessive-compulsive disorder. The US Food and Drug Administration ...