An Overview of the Investigational Device Exemption Regulation
Gatling, Robert R., Jr.
DIABETES CARE 5(3): 282-283, May-June 1982
Showing items related by title, author, creator and subject.
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 ...
Informed Consent and the Investigational Use of Medical Devices: A Comparison of Common Law Duties With Those Imposed on Researchers Under Section 520(g) of the Medical Device Amendments of 1976 Field, Thomas G; Piacenza, Dominic S (1977-12)