{"abstract":"The Food and Drug Administration (FDA) is issuing a proposed administrative order to reclassify the cranial electrotherapy stimulator (CES) devices intended to treat insomnia and/or anxiety, a preamendments class III device, into class II (special controls) and subject to premarket notification, and to require the filing of a premarket approval application (PMA) for CES devices intended to treat depression. FDA is proposing the reclassification of CES devices intended to treat insomnia and/or anxiety under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) based on new information pertaining to the device. This proposed action would implement certain statutory requirements. FDA is also clarifying the identification for CES devices in this proposed order by identifying CES as a prescription device that applies electrical current that is not intended to induce a seizure to a patient's head to treat psychiatric conditions. This clarification distinguishes CES from electroconvulsive therapy (ECT).","action":"Proposed 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/2016/01/22/2016-01173.html","cfr_references":[{"chapter":null,"citation_url":null,"part":882,"title":21}],"citation":"81 FR 3751","comment_url":null,"comments_close_on":"2016-04-21","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on this proposed order by April 21, 2016. See sections IX and XVII of this document for, respectively, the proposed dates when the new requirements apply and the proposed effective date of a final order based on this proposed order.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-N-1209"],"dockets":[{"supporting_documents":[{"title":"Letter accompanying Submission to Proposed Order Docket FWL","document_id":"FDA-2014-N-1209-0314"},{"title":"Fisher Wallace Memo January 9","document_id":"FDA-2014-N-1209-0313"},{"title":"Reference 2 - FDA Executive Summary, Prepared for the February 10, 2012, meeting of the Neurological Devices Panel re Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression","document_id":"FDA-2014-N-1209-0009"},{"title":"Reference 1 - Transcript, February 10, 2012, meeting of the Neurological Devices Panel of the Medical Device Advisory Committee re Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression","document_id":"FDA-2014-N-1209-0008"},{"title":"Reference 30 Quantitative EEG Analysis of Electrosleep Using Analog Frequency Analyzer and Digital Computer Methods re Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression","document_id":"FDA-2014-N-1209-0007"},{"title":"Reference 35, A Clinical Trial of Cranial Electrotherapy Stimulation for Anxiety and Comorbid Depression re Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression","document_id":"FDA-2014-N-1209-0006"},{"title":"Reference 31, Does Electrosleep Induce Natural Sleep? re Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression","document_id":"FDA-2014-N-1209-0005"},{"title":"Reference 32, Ineffectiveness of Elctrosleep in Chronic Primary Insomnia re Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression","document_id":"FDA-2014-N-1209-0004"},{"title":"Reference 33, Studies of Electrosleep on Normal Adults, Insomniacs, and Hypertensive Patients re Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression","document_id":"FDA-2014-N-1209-0003"},{"title":"List of References re Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression","document_id":"FDA-2014-N-1209-0002"}],"agency_name":"FDA","documents":[{"comment_count":304,"comment_start_date":"2016-01-22","updated_at":"2023-02-28T16:28:22.460-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2014-N-1209-0001","allow_late_comments":null,"id":"FDA-2014-N-1209-0001","comment_end_date":"2016-04-22","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":10,"id":"FDA-2014-N-1209","title":"Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator (CES) Intended to Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for CES Intended to Treat Depression"}],"document_number":"2016-01173","effective_on":null,"end_page":3762,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/01/22/2016-01173.xml","html_url":"https://www.federalregister.gov/documents/2016/01/22/2016-01173/neurological-devices-reclassification-of-cranial-electrotherapy-stimulator-intended-to-treat","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-01173?publication_date=2016-01-22","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-01-22/2016-01173/mods.xml","not_received_for_publication":null,"page_length":12,"page_views":{"count":5784,"last_updated":"2026-04-04 04:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-01-22/pdf/2016-01173.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-01173.pdf?1453383936","publication_date":"2016-01-22","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/01/22/2016-01173.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Letter accompanying Submission to Proposed Order Docket FWL","document_id":"FDA-2014-N-1209-0314"},{"title":"Fisher Wallace Memo January 9","document_id":"FDA-2014-N-1209-0313"},{"title":"Reference 2 - FDA Executive Summary, Prepared for the February 10, 2012, meeting of the Neurological Devices Panel re Neurological Devices; 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Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression","toc_doc":"Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression","toc_subject":"Neurological Devices:","topics":["Medical devices"],"type":"Proposed Rule","volume":81}