{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is classifying the transcutaneous electrical nerve stimulator for the relief of congestion 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 classification of the transcutaneous electrical nerve stimulator for the relief of congestion. 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/2026/04/16/2026-07365.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"874","title":21}],"citation":"91 FR 20348","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective April 16, 2026. The classification was applicable on March 5, 2021.","disposition_notes":null,"docket_ids":["Docket No. FDA-2026-N-2959"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":null,"comment_start_date":null,"updated_at":"2026-04-16T14:00:09.169-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2026-N-2959-0001","allow_late_comments":false,"id":"FDA-2026-N-2959-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2026-N-2959","title":"Medical Devices; Ear, Nose, and Throat Devices; Classification of the Transcutaneous Electrical Nerve Stimulator for the Relief of Congestion"}],"document_number":"2026-07365","effective_on":"2026-04-16","end_page":20350,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/04/16/2026-07365.xml","html_url":"https://www.federalregister.gov/documents/2026/04/16/2026-07365/medical-devices-ear-nose-and-throat-devices-classification-of-the-transcutaneous-electrical-nerve","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-07365?publication_date=2026-04-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-04-16/2026-07365/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":280,"last_updated":"2026-04-17 08:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-16/pdf/2026-07365.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-07365.pdf?1776257113","publication_date":"2026-04-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/04/16/2026-07365.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-2026-N-2959","supporting_documents_count":0,"docket_id":"FDA-2026-N-2959","document_id":"FDA-2026-N-2959-0001","regulation_id_number":null,"title":"Medical Devices; Ear, Nose, and Throat Devices; Classification of the Transcutaneous Electrical Nerve Stimulator for the Relief of Congestion","checked_regulationsdotgov_at":"2026-04-17T10:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":20348,"subtype":null,"title":"Medical Devices; Ear, Nose, and Throat Devices; Classification of the Transcutaneous Electrical Nerve Stimulator for the Relief of Congestion","toc_doc":"Ear, Nose, and Throat Devices; Classification of the Transcutaneous Electrical Nerve Stimulator for the Relief of Congestion","toc_subject":"Medical Devices","topics":["Medical devices"],"type":"Rule","volume":91}