{"abstract":"The Food and Drug Administration (FDA) is issuing a final order to reclassify the cranial electrotherapy stimulator (CES) device intended to treat anxiety and/or insomnia, a preamendments class III device, into class II (special controls) and subject to premarket notification. 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 CES devices intended to treat depression (product code JXK) and clarify the device identification of the CES device to include it as a prescription device.","action":"Final amendment; 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/2019/12/20/2019-27295.html","cfr_references":[{"chapter":null,"citation_url":null,"part":882,"title":21}],"citation":"84 FR 70003","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective on December 20, 2019. See further discussion in section V, \"Implementation Strategy.\"","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-N-1209"],"dockets":[],"document_number":"2019-27295","effective_on":"2019-12-20","end_page":70013,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2019/12/20/2019-27295.xml","html_url":"https://www.federalregister.gov/documents/2019/12/20/2019-27295/neurological-devices-reclassification-of-cranial-electrotherapy-stimulator-devices-intended-to-treat","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2019-27295?publication_date=2019-12-20","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2019-12-20/2019-27295/mods.xml","not_received_for_publication":null,"page_length":11,"page_views":{"count":6258,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2019-12-20/pdf/2019-27295.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2019-27295.pdf?1576763118","publication_date":"2019-12-20","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2019/12/20/2019-27295.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; 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"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2014-N-1209","supporting_documents_count":10,"docket_id":"FDA-2014-N-1209","regulation_id_number":null,"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","checked_regulationsdotgov_at":"2019-12-23T09:00:10Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":70003,"subtype":null,"title":"Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Devices Intended To Treat Anxiety and/or Insomnia; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Devices Intended To Treat Depression","toc_doc":"Reclassification of Cranial Electrotherapy Stimulator Devices Intended to Treat Anxiety and/or Insomnia; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Devices Intended to Treat Depression","toc_subject":"Neurological Devices:\n","topics":["Medical devices"],"type":"Rule","volume":84}