{"abstract":"The Food and Drug Administration (FDA) is classifying the non- medicated topical formulation for treatment of erectile dysfunction 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 non-medicated topical formulation for treatment of erectile dysfunction. 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/2026/07/27/2026-15074.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"876","title":21}],"citation":"91 FR 46833","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective July 27, 2026. The classification was applicable on June 9, 2023.","disposition_notes":null,"docket_ids":["Docket No. FDA-2026-N-7628"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-07-27","updated_at":"2026-07-27T09:57:01.499-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2026-N-7628-0001","allow_late_comments":false,"id":"FDA-2026-N-7628-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2026-N-7628","title":"Medical Devices; Gastroenterology-Urology Devices; Classification of the Non-Medicated Topical Formulation for Treatment of Erectile Dysfunction"}],"document_number":"2026-15074","effective_on":"2026-07-27","end_page":46834,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/07/27/2026-15074.xml","html_url":"https://www.federalregister.gov/documents/2026/07/27/2026-15074/medical-devices-gastroenterology-urology-devices-classification-of-the-non-medicated-topical","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-15074?publication_date=2026-07-27","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-07-27/2026-15074/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1525,"last_updated":"2026-09-21 08:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-27/pdf/2026-15074.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-15074.pdf?1784897110","publication_date":"2026-07-27","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/07/27/2026-15074.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-7628","supporting_documents_count":0,"docket_id":"FDA-2026-N-7628","document_id":"FDA-2026-N-7628-0001","regulation_id_number":null,"title":"Medical Devices; Gastroenterology-Urology Devices; Classification of the Non-Medicated Topical Formulation for Treatment of Erectile Dysfunction","checked_regulationsdotgov_at":"2026-07-28T16:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":46833,"subtype":null,"title":"Medical Devices; Gastroenterology-Urology Devices; Classification of the Non-Medicated Topical Formulation for Treatment of Erectile Dysfunction","toc_doc":"Gastroenterology-Urology Devices; Classification of the Non-Medicated Topical Formulation for Treatment of Erectile Dysfunction","toc_subject":"Medical Devices","topics":["Medical devices"],"type":"Rule","volume":91}