Misuse Of The FDA’s Humanitarian Device Exemption In Deep Brain Stimulation For Obsessive-Compulsive Disorder
Fins J, Mayberg H, Nuttin B, Kubu C, Galert T, Sturm V, Stoppenbrink K, Merkel R, Schlaepfer T. Misuse Of The FDA’s Humanitarian Device Exemption In Deep Brain Stimulation For Obsessive-Compulsive Disorder. Health Affairs 2011, 30: 302-311. PMID: 21289352, DOI: 10.1377/hlthaff.2010.0157.Peer-Reviewed Original ResearchConceptsObsessive-compulsive disorderHumanitarian Device ExemptionSevere obsessive-compulsive disorderUS Food and Drug AdministrationFDA humanitarian device exemptionNeuropsychiatric disordersFood and Drug AdministrationDeep brain stimulationClinical trialsBrain stimulationDrug AdministrationDisordersPatientsFederal regulationsPatient safeguardsProcedure—isExemption