{"abstract":"The Food and Drug Administration (FDA or the Agency) is proposing to reclassify surgical mesh for transvaginal pelvic organ prolapse (POP) repair from class II to class III. FDA is proposing this reclassification based on the tentative determination that general controls and special controls together are not sufficient to provide reasonable assurance of safety and effectiveness for this device. In addition, FDA is proposing to reclassify urogynecologic surgical mesh instrumentation from class I to class II. The Agency is also proposing to establish special controls for surgical instrumentation for use with urogynecologic surgical mesh. FDA is proposing this action, based on the tentative determination that general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of these devices, and there is sufficient information to establish special controls to provide such assurance. The Agency is reclassifying both the surgical mesh for transvaginal repair and the urogynecologic surgical mesh instrumentation on its own initiative based on new information.","action":"Proposed 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/2014/05/01/2014-09907.html","cfr_references":[{"chapter":null,"citation_url":null,"part":884,"title":21}],"citation":"79 FR 24634","comment_url":null,"comments_close_on":"2014-07-30","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on this proposed order by July 30, 2014. Please see section XIII for the proposed effective date of any final order that may publish based on this proposal.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-N-0297"],"dockets":[],"document_number":"2014-09907","effective_on":null,"end_page":24642,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/05/01/2014-09907.xml","html_url":"https://www.federalregister.gov/documents/2014/05/01/2014-09907/reclassification-of-surgical-mesh-for-transvaginal-pelvic-organ-prolapse-repair-and-surgical","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-09907?publication_date=2014-05-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-05-01/2014-09907/mods.xml","not_received_for_publication":null,"page_length":9,"page_views":{"count":8451,"last_updated":"2026-06-24 22:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-05-01/pdf/2014-09907.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-09907.pdf?1398775630","publication_date":"2014-05-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/05/01/2014-09907.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 27, Moore RD, Mitchell GK, Miklos JR. Single-incision vaginal approach to treat cystocele and vault prolapse with an anteriory...2012 re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecolo","document_id":"FDA-2014-N-0297-0101"},{"title":"Reference 23, Stanford EJ, Moore RD, Roovers JP et al. Elevate anterior-apical-12-month data showing safety and efficacy in surgical treatment...2013 re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogy","document_id":"FDA-2014-N-0297-0097"},{"title":"Reference 20, Barski D, Otto T, Gerullis H. Systematic review and classification of complications after anterior, posterior, apical, and total vaginal mesh...2014 re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for U","document_id":"FDA-2014-N-0297-0094"},{"title":"Reference 17, Onwude JL. Genital prolapse in women. Clin Evid (Online) 2012 Mar 14 re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh","document_id":"FDA-2014-N-0297-0091"},{"title":"Reference 15, Abed et al. Int Urogynecol. 2011 re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh","document_id":"FDA-2014-N-0297-0089"},{"title":"Reference 13 & 32, Pelvic Florr Disorders Registery re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh","document_id":"FDA-2014-N-0297-0085"},{"title":"Reference 12 (2017 FO), Hiltunen et al., Low-Weight Polyprophoylene Mesh for Anterior re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh","document_id":"FDA-2014-N-0297-0083"},{"title":"Reference 11(2017 FO), Sung et al., Graft Use in Trasvaginal Pelvic Organ Prolapse and Urinary Incontinence re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh","document_id":"FDA-2014-N-0297-0081"},{"title":"Reference 7, Armitage S, Seman EI, Keirse MJ. Use of surgisis for treatment of anterior and posterior vaginal prolapse. Obstet Gynecol Int. 2012 re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh","document_id":"FDA-2014-N-0297-0075"},{"title":"Reference 3(2017 FO),Transcript of the February 26, 2016, meeting of the Gastroenterology-Urology Devices Panel re Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh","document_id":"FDA-2014-N-0297-0067"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2014-N-0297","supporting_documents_count":83,"docket_id":"FDA-2014-N-0297","regulation_id_number":null,"title":"Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair and Surgical Instrumentation for Urogynecologic Surgical Mesh Procedures; Designation of Special Controls for Urogynecologic Surgical Mesh Instrumentation","checked_regulationsdotgov_at":"2014-07-31T12:00:20Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":24634,"subtype":null,"title":"Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair and Surgical Instrumentation for Urogynecologic Surgical Mesh Procedures; Designation of Special Controls for Urogynecologic Surgical Mesh Instrumentation","toc_doc":"Surgical Mesh; Transvaginal Pelvic Organ Prolapse Repair and Surgical Instrumentation; Urogynecologic Procedures; Reclassification; etc.","toc_subject":"Medical Devices:","topics":["Medical devices"],"type":"Proposed Rule","volume":79}