{"abstract":"The Food and Drug Administration (FDA) is amending the identification of manual gastroenterology-urology surgical instruments and accessories to reflect that the device does not include specialized surgical instrumentation for use with urogyencologic surgical mesh specifically intended for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures (\"specialized surgical instrumentation for use with urogynecologic surgical mesh\"). These amendments are being made to reflect changes made in the recently issued final reclassification order for specialized surgical instrumentation for use with urogynecologic surgical mesh.","action":"Final rule; technical amendment.","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/2017/03/01/2017-03997.html","cfr_references":[{"chapter":null,"citation_url":null,"part":876,"title":21}],"citation":"82 FR 12171","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective March 1, 2017.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-N-4661"],"dockets":[],"document_number":"2017-03997","effective_on":"2017-03-01","end_page":12171,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2017/03/01/2017-03997.xml","html_url":"https://www.federalregister.gov/documents/2017/03/01/2017-03997/gastroenterology-urology-devices-manual-gastroenterology-urology-surgical-instruments-and","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2017-03997?publication_date=2017-03-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2017-03-01/2017-03997/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":336,"last_updated":"2026-07-26 06:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2017-03-01/pdf/2017-03997.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2017-03997.pdf?1488289569","publication_date":"2017-03-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2017/03/01/2017-03997.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-2016-N-4661","supporting_documents_count":0,"docket_id":"FDA-2016-N-4661","regulation_id_number":null,"title":"Gastroenterology-urology Devices; Manual gastroenterology-urology surgical instrument and accessories","checked_regulationsdotgov_at":"2017-03-21T06:00:17Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":12171,"subtype":null,"title":"Gastroenterology-Urology Devices; Manual Gastroenterology-Urology Surgical Instruments and Accessories","toc_doc":"Gastroenterology-Urology Devices; Manual Gastroenterology-Urology Surgical Instruments and Accessories","toc_subject":"Medical Devices:","topics":["Medical devices"],"type":"Rule","volume":82}