{"abstract":"The Food and Drug Administration (FDA or we) is classifying the endoscopic transhepatic venous access needle 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 endoscopic transhepatic venous access needle's classification. We are taking this action because we have determined that classifying the device into class II (special controls) 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.","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/2021/12/15/2021-27135.html","cfr_references":[{"chapter":null,"citation_url":null,"part":876,"title":21}],"citation":"86 FR 71144","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective December 15, 2021. The classification was applicable on November 20, 2019.","disposition_notes":null,"docket_ids":["Docket No. FDA-2021-N-0590"],"dockets":[],"document_number":"2021-27135","effective_on":"2021-12-15","end_page":71145,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/12/15/2021-27135.xml","html_url":"https://www.federalregister.gov/documents/2021/12/15/2021-27135/medical-devices-gastroenterology-urology-devices-classification-of-the-endoscopic-transhepatic","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2021-27135?publication_date=2021-12-15","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-12-15/2021-27135/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":287,"last_updated":"2026-04-05 00:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-12-15/pdf/2021-27135.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-27135.pdf?1639489538","publication_date":"2021-12-15","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/12/15/2021-27135.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-2021-N-0590","supporting_documents_count":0,"docket_id":"FDA-2021-N-0590","document_id":"FDA-2021-N-0590-0001","regulation_id_number":null,"title":"Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Transhepatic Venous Access Needle","checked_regulationsdotgov_at":"2021-12-16T04:30:10Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":71144,"subtype":null,"title":"Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Transhepatic Venous Access Needle","toc_doc":"Gastroenterology-Urology Devices; Classification of the Endoscopic Transhepatic Venous Access Needle","toc_subject":"Medical Devices:\n","topics":[],"type":"Rule","volume":86}