title: Electroconvulsive therapy device classification: response to FDA advisory panel hearing and recommendations.
abstract: Electroconvulsive therapy (ECT) is a safe and highly effective treatment for management of acute episodes of a variety of serious mental disorders, particularly for major depressive episodes that are resistant to multiple interventions with treatment alternatives. As such, the National Network of Depression Centers (NNDC), a consortium of major academic centers with interest and expertise in this area, believes there is an important public health need for ECT to remain available for clinical use. As with all medical devices, ECT is regulated by the US Food and Drug Administration (FDA), which is presently involved in formulating a proposed rule as to how such devices should be classified. Since such classification may have substantial effects on the availability of ECT to patients for whom it is clinically indicated, the NNDC has reviewed the information provided by the FDA to its Advisory Panel, as well as the subsequent deliberations of the Panel itself at a January 2011 public hearing. This review indicates that the FDA may have substantially underestimated the efficacy of ECT as a means to produce large clinical improvements for individuals suffering from severe major depressive disorders and that such an underestimate likely affected the Panel's willingness to recommend reclassification of ECT devices to a less restrictive category. In addition, the NNDC's review generates support for a variety of methods by which the safety of ECT can be ensured, which is an essential requirement for such reclassification.
authors: Duke Medical Center Department of Psychiatry and Behavioral Sciences, Durham, NC 27710, USA. richard.weiner@duke.edu
authors: Richard
authors: R
authors: Weiner
authors: Sarah H
authors: SH
authors: Lisanby
authors: Mustafa M
authors: MM
authors: Husain
authors: Oscar G
authors: OG
authors: Morales
authors: Daniel F
authors: DF
authors: Maixner
authors: Stephen E
authors: SE
authors: Hall
authors: James
authors: J
authors: Beeghly
authors: John F
authors: JF
authors: Greden
mesh_terms: D000208:Acute Disease; D026683:Advisory Committees; D000647:Amnesia / Q000175:diagnosis / Q000209:etiology; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D061218:Depressive Disorder, Treatment-Resistant / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D018795:Device Approval; D004565:Electroconvulsive Therapy / Q000009:adverse effects / Q000295:instrumentation*; D004867:Equipment Design / Q000145:classification*; D006801:Humans; D009483:Neuropsychological Tests; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration