{"abstract":"The Food and Drug Administration (FDA) is classifying the rectal control system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the rectal control system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.","action":"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/2015/06/01/2015-13067.html","cfr_references":[{"chapter":null,"citation_url":null,"part":876,"title":21}],"citation":"80 FR 30931","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective June 1, 2015. The classification was applicable on February 12, 2015.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-N-1338"],"dockets":[],"document_number":"2015-13067","effective_on":"2015-06-01","end_page":30933,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/06/01/2015-13067.xml","html_url":"https://www.federalregister.gov/documents/2015/06/01/2015-13067/medical-devices-gastroenterology-urology-devices-classification-of-the-rectal-control-system","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-13067?publication_date=2015-06-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-06-01/2015-13067/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":256,"last_updated":"2026-09-21 20:15:12 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-06-01/pdf/2015-13067.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-13067.pdf?1432903537","publication_date":"2015-06-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/06/01/2015-13067.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2015-N-1338","supporting_documents_count":0,"docket_id":"FDA-2015-N-1338","regulation_id_number":null,"title":"Classification of the Rectal Control System","checked_regulationsdotgov_at":"2015-06-21T06:00:12Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":30931,"subtype":null,"title":"Medical Devices; Gastroenterology-Urology Devices; Classification of the Rectal Control System","toc_doc":"GastroenterologyUrology Devices; Classification of the Rectal Control System","toc_subject":"Medical Devices:","topics":["Medical devices"],"type":"Rule","volume":80}