{"abstract":"The Food and Drug Administration (FDA) is classifying the external condom for anal intercourse or vaginal intercourse 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 external condom for anal intercourse or vaginal intercourse. 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/2026/05/08/2026-09152.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"884","title":21}],"citation":"91 FR 25109","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective May 8, 2026. The classification was applicable on February 23, 2022.","disposition_notes":null,"docket_ids":["Docket No. FDA-2026-N-4659"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":null,"comment_start_date":null,"updated_at":"2026-05-08T10:04:12.091-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2026-N-4659-0001","allow_late_comments":false,"id":"FDA-2026-N-4659-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2026-N-4659","title":"Medical Devices; Obstetrical and Gynecological Devices; Classification of the External Condom for Anal Intercourse or Vaginal Intercourse"}],"document_number":"2026-09152","effective_on":"2026-05-08","end_page":25112,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/05/08/2026-09152.xml","html_url":"https://www.federalregister.gov/documents/2026/05/08/2026-09152/medical-devices-obstetrical-and-gynecological-devices-classification-of-the-external-condom-for-anal","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-09152?publication_date=2026-05-08","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-05-08/2026-09152/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":1134,"last_updated":"2026-05-10 10:15:10 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-08/pdf/2026-09152.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-09152.pdf?1778157914","publication_date":"2026-05-08","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/05/08/2026-09152.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-4659","supporting_documents_count":0,"docket_id":"FDA-2026-N-4659","document_id":"FDA-2026-N-4659-0001","regulation_id_number":null,"title":"Medical Devices; Obstetrical and Gynecological Devices; Classification of the External Condom for Anal Intercourse or Vaginal Intercourse","checked_regulationsdotgov_at":"2026-05-09T12:55:06Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":25109,"subtype":null,"title":"Medical Devices; Obstetrical and Gynecological Devices; Classification of the External Condom for Anal Intercourse or Vaginal Intercourse","toc_doc":"Obstetrical and Gynecological Devices; Classification of the External Condom for Anal Intercourse or Vaginal Intercourse","toc_subject":"Medical Devices","topics":["Medical devices"],"type":"Rule","volume":91}