{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is classifying the electrical tongue nerve stimulator to treat motor deficits into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the classification of the electrical tongue nerve stimulator to treat motor deficits. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.","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/2025/12/19/2025-23413.html","cfr_references":[{"chapter":null,"citation_url":null,"part":882,"title":21}],"citation":"90 FR 59377","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective December 19, 2025. The classification was applicable on March 25, 2021.","disposition_notes":null,"docket_ids":["Docket No. FDA-2025-N-6025"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2025-12-19","updated_at":"2025-12-19T11:57:21.223-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2025-N-6025-0001","allow_late_comments":false,"id":"FDA-2025-N-6025-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2025-N-6025","title":"Medical Devices; Neurological Devices; Classification of the Electrical Tongue Nerve Stimulator to Treat Motor Deficits"}],"document_number":"2025-23413","effective_on":"2025-12-19","end_page":59379,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/12/19/2025-23413.xml","html_url":"https://www.federalregister.gov/documents/2025/12/19/2025-23413/medical-devices-neurological-devices-classification-of-the-electrical-tongue-nerve-stimulator-to","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-23413?publication_date=2025-12-19","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-12-19/2025-23413/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":247,"last_updated":"2026-04-04 02:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-12-19/pdf/2025-23413.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-23413.pdf?1766065522","publication_date":"2025-12-19","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/12/19/2025-23413.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2025-N-6025","supporting_documents_count":0,"docket_id":"FDA-2025-N-6025","document_id":"FDA-2025-N-6025-0001","regulation_id_number":null,"title":"Medical Devices; Neurological Devices; Classification of the Electrical Tongue Nerve Stimulator to Treat Motor Deficits","checked_regulationsdotgov_at":"2025-12-20T20:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":59377,"subtype":null,"title":"Medical Devices; Neurological Devices; Classification of the Electrical Tongue Nerve Stimulator To Treat Motor Deficits","toc_doc":"Neurological Devices; Classification of the Electrical Tongue Nerve Stimulator to Treat Motor Deficits","toc_subject":"Medical Devices","topics":["Medical devices"],"type":"Rule","volume":90}