{"abstract":"The Food and Drug Administration (FDA or the Agency) is issuing a final order to require the filing of a premarket approval application (PMA) or notice of completion of a product development protocol (PDP) for surgical mesh for transvaginal pelvic organ prolapse (POP) repair.","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/2016/01/05/2015-33163.html","cfr_references":[{"chapter":null,"citation_url":null,"part":884,"title":21}],"citation":"81 FR 364","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective on January 5, 2016.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-N-0298"],"dockets":[],"document_number":"2015-33163","effective_on":"2016-01-05","end_page":370,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/01/05/2015-33163.xml","html_url":"https://www.federalregister.gov/documents/2016/01/05/2015-33163/effective-date-of-requirement-for-premarket-approval-for-surgical-mesh-for-transvaginal-pelvic-organ","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-33163?publication_date=2016-01-05","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-01-05/2015-33163/mods.xml","not_received_for_publication":null,"page_length":7,"page_views":{"count":4251,"last_updated":"2026-06-24 00:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-01-05/pdf/2015-33163.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-33163.pdf?1451915188","publication_date":"2016-01-05","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/01/05/2015-33163.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference  6 (PMA), Guidance for Industry Pyrogen and Endotoxins Testing Questions and Answers re Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair","document_id":"FDA-2014-N-0298-0012"},{"title":"Reference 5 (PMA), FDA's Urogynecologic Surgical Mesh Implants Webpage re Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair","document_id":"FDA-2014-N-0298-0011"},{"title":"Reference 4 (PMA), UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse_ FDA Safety Communication re Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvi","document_id":"FDA-2014-N-0298-0010"},{"title":"Reference 3 (PMA), Blue Book Memo G95-1 re Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair","document_id":"FDA-2014-N-0298-0009"},{"title":"Reference 2 (PMA), Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh re Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair","document_id":"FDA-2014-N-0298-0008"},{"title":"Reference 1-a - Ob Gyn Panel Meeting Transcript. September 9, 2011 re Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair","document_id":"FDA-2014-N-0298-0007"},{"title":"Reference 1 - Ob Gyn Panel Meeting Transcript. September  8, 2011 re Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair","document_id":"FDA-2014-N-0298-0006"},{"title":"List of References re Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair","document_id":"FDA-2014-N-0298-0005"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2014-N-0298","supporting_documents_count":8,"docket_id":"FDA-2014-N-0298","regulation_id_number":null,"title":"Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair","checked_regulationsdotgov_at":"2016-01-25T06:00:12Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":364,"subtype":null,"title":"Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair","toc_doc":"Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair","toc_subject":null,"topics":["Medical devices"],"type":"Rule","volume":81}