{"abstract":"The Food and Drug Administration (FDA or the Agency) is issuing a proposed administrative order to require the filing of a premarket approval application (PMA) if the surgical mesh for transvaginal pelvic organ prolapse (POP) repair device is reclassified from class II to class III. The Agency is summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the device to meet the statute's PMA requirements and the benefit to the public from the use of the device.","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/2014/05/01/2014-09909.html","cfr_references":[{"chapter":null,"citation_url":null,"part":884,"title":21}],"citation":"79 FR 24642","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. FDA intends that, if a final order based on this proposed order is issued, anyone who wishes to continue to market the device will need to submit a PMA within 90 days of the effective date of the final order or on the last day of the 30th calendar month beginning after the month in which the classification of the device in class III became effective, whichever occurs later. See section VI for more information about submitting a PMA. See section X for the effective date of any final order that may publish based on this proposal.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-N-0298"],"dockets":[],"document_number":"2014-09909","effective_on":null,"end_page":24648,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/05/01/2014-09909.xml","html_url":"https://www.federalregister.gov/documents/2014/05/01/2014-09909/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/2014-09909?publication_date=2014-05-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-05-01/2014-09909/mods.xml","not_received_for_publication":null,"page_length":7,"page_views":{"count":3322,"last_updated":"2026-07-26 04:15:02 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-05-01/pdf/2014-09909.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-09909.pdf?1398775636","publication_date":"2014-05-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/05/01/2014-09909.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":"2014-07-31T12:00:21Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":24642,"subtype":null,"title":"Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair","toc_doc":"Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair","toc_subject":"Premarket Approvals:","topics":["Medical devices"],"type":"Proposed Rule","volume":79}