{"abstract":"The Food and Drug Administration (FDA) is issuing a final order to reclassify the electroconvulsive therapy (ECT) device for use in treating catatonia or a severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients age 13 years and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition, which is a preamendments class III device, into class II (special controls). FDA is also issuing this final order to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the preamendments class III ECT devices for all other uses that are not being reclassified to class II (product code GXC).","action":"Final order.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2018/12/26/2018-27809.html","cfr_references":[{"chapter":null,"citation_url":null,"part":882,"title":21}],"citation":"83 FR 66103","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective on December 26, 2018. See further discussion in section V, Implementation Strategy.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-N-1210"],"dockets":[],"document_number":"2018-27809","effective_on":"2018-12-26","end_page":66124,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/12/26/2018-27809.xml","html_url":"https://www.federalregister.gov/documents/2018/12/26/2018-27809/neurological-devices-reclassification-of-electroconvulsive-therapy-devices-effective-date-of","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-27809?publication_date=2018-12-26","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-12-26/2018-27809/mods.xml","not_received_for_publication":null,"page_length":22,"page_views":{"count":8407,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-12-26/pdf/2018-27809.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-27809.pdf?1545399926","publication_date":"2018-12-26","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/12/26/2018-27809.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 58-Brown E.D. et al. Efficacy of continuation-maintenance electroconvulsive therapy for the prevention of recurrence of a major depressi  RE:  Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Require","document_id":"FDA-2014-N-1210-3494"},{"title":"Reference 60-Tor, P.C., et al., A Systematic Review and Meta-Analysis of Brief Versus Ultrabrief Right Unilateral Electroconvulsive Therapy for Depression Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of R","document_id":"FDA-2014-N-1210-3489"},{"title":"Reference 56-FDA, MedWatch- The FDA Safety Information and Adverse Event Reporting Program Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy ","document_id":"FDA-2014-N-1210-3486"},{"title":"Reference 51-Small, J.G., et al., Electroconvulsive treatment compared with lithium in the management of manic states Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for","document_id":"FDA-2014-N-1210-3481"},{"title":"Reference 48-Lehman, A.F., et al., Practice guideline for the treatment of patients with schizophrenia, second edition Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval fo","document_id":"FDA-2014-N-1210-3478"},{"title":"Reference 47-Petrides, G., et al., Electroconvulsive therapy augmentation in clozapine-resistant schizophrenia- a prospective, randomized study Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement ","document_id":"FDA-2014-N-1210-3477"},{"title":"Reference 37-Strober, M., et al., Effects of electroconvulsive therapy in adolescents with severe endogenous depression resistant to pharmacotherapy  Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses","document_id":"FDA-2014-N-1210-3467"},{"title":"Reference 35-Walter, G. and J.M. Rey, An epidemiological study of the use of ECT in adolescents  Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses","document_id":"FDA-2014-N-1210-3465"},{"title":"Reference 33-Consoli, A., et al., Electroconvulsive therapy in adolescents with the catatonia syndrome- efficacy and ethics  Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses","document_id":"FDA-2014-N-1210-3463"},{"title":"Reference 29-Puffer, C.C., et al., A 20 Year Practice Review of Electroconvulsive Therapy for Adolescents  Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses","document_id":"FDA-2014-N-1210-3459"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2014-N-1210","supporting_documents_count":75,"docket_id":"FDA-2014-N-1210","regulation_id_number":null,"title":"Neurological Devices; Reclassification of Electroconvulsive Therapy (ECT) Devices Intended for Use in Treating Severe Major Depressive Episode in Patients 18 Years of Age and Older Who are Treatment Resistant or Require a Rapid Response; Effective Date of Requirement for Premarket Approval for ECT for Certain Specified Intended Uses","checked_regulationsdotgov_at":"2019-01-15T11:00:16Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":66103,"subtype":null,"title":"Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses","toc_doc":"Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses","toc_subject":null,"topics":["Medical devices"],"type":"Rule","volume":83}