{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled \"Product Labeling for Laparoscopic Power Morcellators.\" This guidance updates recommended \"Contraindications\" and \"Warnings\" information to be included in product labeling to reflect the state of the science and available technology regarding use of laparoscopic power morcellators (LPMs). These labeling recommendations are intended to enhance, but not replace, the physician-patient discussion of the benefits and risks of use of LPMs that uniquely pertain to individual patients.","action":"Notice of availability.","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/2020/12/30/2020-28816.html","cfr_references":[],"citation":"85 FR 86570","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on December 30, 2020.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-D-1804"],"dockets":[],"document_number":"2020-28816","effective_on":null,"end_page":86571,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/12/30/2020-28816.xml","html_url":"https://www.federalregister.gov/documents/2020/12/30/2020-28816/product-labeling-for-laparoscopic-power-morcellators-guidance-for-industry-and-food-and-drug","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-28816?publication_date=2020-12-30","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-12-30/2020-28816/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":305,"last_updated":"2026-07-27 22:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-12-30/pdf/2020-28816.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-28816.pdf?1609249527","publication_date":"2020-12-30","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/12/30/2020-28816.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 2 Public Meeting in 2014, Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee, Federal Register Notice re Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power Morcellators; Guidance for Industry and Food and Drug Administration Staff; Availability FDA-2014-D-1804-0001","document_id":"FDA-2014-D-1804-0003"},{"title":"Reference 1 FDA Center for Devices and Radiological Health, Safety Communications Page Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy re Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power Morcellators; Guidance for Industry and Food and Drug Administration Staff; Availability FDA-2014-D-1804-0001","document_id":"FDA-2014-D-1804-0002"}],"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-2014-D-1804","supporting_documents_count":2,"docket_id":"FDA-2014-D-1804","document_id":"FDA-2014-D-1804-0073","regulation_id_number":null,"title":"Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power Morcellators; Guidance for Industry and Food and Drug Administration Staff; Availability","checked_regulationsdotgov_at":"2021-01-01T04:30:09Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":86570,"subtype":null,"title":"Product Labeling for Laparoscopic Power Morcellators; Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Product Labeling for Laparoscopic Power Morcellators","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":85}