{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is proposing to ban electrical stimulation devices (ESDs) intended for self-injurious behavior (SIB) or aggressive behavior (AB). FDA has determined these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling. This proposal follows a court decision vacating a prior ban and amendment to the Federal Food, Drug, and Cosmetic Act clarifying our authority to ban a device for one or more intended uses. This action, if finalized, will mean ESDs for SIB and AB are adulterated and not legally marketed.","action":"Proposed rule.","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/2024/03/26/2024-06037.html","cfr_references":[{"chapter":null,"citation_url":null,"part":882,"title":21},{"chapter":null,"citation_url":null,"part":895,"title":21}],"citation":"89 FR 20882","comment_url":null,"comments_close_on":"2024-05-28","correction_of":null,"corrections":[],"dates":"Either electronic or written comments on the proposed rule must be submitted by May 28, 2024.","disposition_notes":null,"docket_ids":["Docket No. FDA-2023-N-3902"],"dockets":[{"supporting_documents":[{"title":"Comment from Arthur Manoogian","document_id":"FDA-2023-N-3902-1466"},{"title":"Comment from Commonwealth Council on Developmental Disabilities","document_id":"FDA-2023-N-3902-1462"},{"title":"Comment from Michael DeJoy","document_id":"FDA-2023-N-3902-1460"},{"title":"Comment from Gerald Gerrard","document_id":"FDA-2023-N-3902-1457"},{"title":"Comment from Anonymous","document_id":"FDA-2023-N-3902-1455"},{"title":"Comment from Elizabeth Altieri","document_id":"FDA-2023-N-3902-1452"},{"title":"Comment from Jennifer St Jude","document_id":"FDA-2023-N-3902-1250"},{"title":"Comment from Anonymous","document_id":"FDA-2023-N-3902-1241"},{"title":"Comment from N Hurley","document_id":"FDA-2023-N-3902-1237"},{"title":"Comment from Lisa Anne Wray","document_id":"FDA-2023-N-3902-1236"}],"agency_name":"FDA","documents":[{"comment_count":8717,"comment_start_date":"2024-03-26","updated_at":"2024-09-03T16:49:33.253-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-N-3902-0001","allow_late_comments":false,"id":"FDA-2023-N-3902-0001","comment_end_date":"2024-05-29","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":1840,"id":"FDA-2023-N-3902","title":"Banned Devices; Proposal to Ban Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior Center: Center for Devices and Radiological Health"}],"document_number":"2024-06037","effective_on":null,"end_page":20897,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/03/26/2024-06037.xml","html_url":"https://www.federalregister.gov/documents/2024/03/26/2024-06037/banned-devices-proposal-to-ban-electrical-stimulation-devices-for-self-injurious-or-aggressive","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-06037?publication_date=2024-03-26","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-03-26/2024-06037/mods.xml","not_received_for_publication":null,"page_length":16,"page_views":{"count":7111,"last_updated":"2026-04-03 16:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-03-26/pdf/2024-06037.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-06037.pdf?1711370716","publication_date":"2024-03-26","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/03/26/2024-06037.txt","regulation_id_number_info":{"0910-AI84":{"issue":"202410","html_url":"https://www.federalregister.gov/regulations/0910-AI84/banned-devices-electrical-stimulation-devices-intended-for-self-injurious-behavior-or-aggressive-beh","title":"Banned Devices; Electrical Stimulation Devices Intended for Self-Injurious Behavior or Aggressive Behavior","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202410&RIN=0910-AI84&operation=OPERATION_EXPORT_XML","priority_category":"Substantive, Nonsignificant"}},"regulation_id_numbers":["0910-AI84"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Comment from Arthur Manoogian","document_id":"FDA-2023-N-3902-1466"},{"title":"Comment from Commonwealth Council on Developmental Disabilities","document_id":"FDA-2023-N-3902-1462"},{"title":"Comment from Michael DeJoy","document_id":"FDA-2023-N-3902-1460"},{"title":"Comment from Gerald Gerrard","document_id":"FDA-2023-N-3902-1457"},{"title":"Comment from Anonymous","document_id":"FDA-2023-N-3902-1455"},{"title":"Comment from Elizabeth Altieri","document_id":"FDA-2023-N-3902-1452"},{"title":"Comment from Jennifer St Jude","document_id":"FDA-2023-N-3902-1250"},{"title":"Comment from Anonymous","document_id":"FDA-2023-N-3902-1241"},{"title":"Comment from N Hurley","document_id":"FDA-2023-N-3902-1237"},{"title":"Comment from Lisa Anne Wray","document_id":"FDA-2023-N-3902-1236"}],"comments_count":8717,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2023-N-3902","supporting_documents_count":1840,"docket_id":"FDA-2023-N-3902","document_id":"FDA-2023-N-3902-0001","regulation_id_number":null,"title":"Banned Devices; Proposal to Ban Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior Center: Center for Devices and Radiological Health","checked_regulationsdotgov_at":"2024-06-30T01:00:08Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":20882,"subtype":null,"title":"Banned Devices; Proposal To Ban Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior","toc_doc":"Proposal to Ban Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior","toc_subject":"Banned Devices:\n","topics":["Administrative practice and procedure","Labeling","Medical devices"],"type":"Proposed Rule","volume":89}