{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is finalizing a ban on electrical stimulation devices (ESDs) for self- injurious or aggressive behavior. FDA has determined that these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling. This ban includes both new devices and devices already in distribution and use; however, this ban provides transition time for those individuals currently subject to ESDs for the identified intended use to transition off ESDs under the supervision of a physician.","action":"Final 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/2020/03/06/2020-04328.html","cfr_references":[{"chapter":null,"citation_url":null,"part":882,"title":21},{"chapter":null,"citation_url":null,"part":895,"title":21}],"citation":"85 FR 13312","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective April 6, 2020. However, compliance for devices currently in use and subject to a physician-directed transition plan is required on September 2, 2020. Compliance for all other devices is required on April 6, 2020.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-N-1111"],"dockets":[],"document_number":"2020-04328","effective_on":"2020-04-06","end_page":13354,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/03/06/2020-04328.xml","html_url":"https://www.federalregister.gov/documents/2020/03/06/2020-04328/banned-devices-electrical-stimulation-devices-for-self-injurious-or-aggressive-behavior","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-04328?publication_date=2020-03-06","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-03-06/2020-04328/mods.xml","not_received_for_publication":null,"page_length":43,"page_views":{"count":21887,"last_updated":"2026-04-04 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-03-06/pdf/2020-04328.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-04328.pdf?1583329525","publication_date":"2020-03-06","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/03/06/2020-04328.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 138 - SA Gant, Gant Yackel & Assocs, letter re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior","document_id":"FDA-2016-N-1111-0143"},{"title":"Reference 133 - The path to aversive interventions re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior","document_id":"FDA-2016-N-1111-0138"},{"title":"Reference 131 - Response to Testimony and Written Comments to Proposed Amendments re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior","document_id":"FDA-2016-N-1111-0136"},{"title":"Reference 118 - The effects of extinction, noncontingent reinforcement, and differential reinforcement etc re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior","document_id":"FDA-2016-N-1111-0123"},{"title":"Reference 114 - An evaluation of an intervention sequence outline in PBS for people with autism etc re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior","document_id":"FDA-2016-N-1111-0119"},{"title":"Reference 100 - Anatomy of self-injurious, stereotypic, and aggressive movements re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior","document_id":"FDA-2016-N-1111-0104"},{"title":"Reference 99 - Positive Behavior Support for People with Developmental Disabilities re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior","document_id":"FDA-2016-N-1111-0103"},{"title":"Reference 95 - Positive behavioral support of adults with developmental disabilities re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior","document_id":"FDA-2016-N-1111-0099"},{"title":"Reference 86 - Manipulation of potential punishment parameters in the treatment of self-injury re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior","document_id":"FDA-2016-N-1111-0090"},{"title":"Reference 82 - Use of behaviour modification techniques in a community service for mentally handicapped children re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior","document_id":"FDA-2016-N-1111-0086"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2016-N-1111","supporting_documents_count":300,"docket_id":"FDA-2016-N-1111","regulation_id_number":null,"title":"Banned Devices; Proposal to Ban Electrical Stimulation Devices Used to Treat Self-Injurious or Aggressive Behavior","checked_regulationsdotgov_at":"2020-03-23T11:30:31Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":13312,"subtype":null,"title":"Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior","toc_doc":null,"toc_subject":null,"topics":["Administrative practice and procedure","Labeling","Medical devices"],"type":"Rule","volume":85}