{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled \"Menstrual Products-- Performance Testing and Labeling Recommendations.\" This draft guidance document provides recommendations for performance testing, labeling, and information for inclusion in premarket notification (510(k)) submissions, when necessary, for certain menstrual products. The recommendations in this guidance apply to tampons, pads, and menstrual cups used to absorb or collect menstrual fluid or other vaginal discharge. The recommendations reflect updated review practices and are intended to promote consistency and transparency in product labeling and testing for manufacturers of these devices. This draft guidance is not final nor is it for implementation at this time.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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/2025/11/17/2025-19948.html","cfr_references":[],"citation":"90 FR 51371","comment_url":null,"comments_close_on":"2026-01-16","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by January 16, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2025-D-5107"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2025-11-17","updated_at":"2025-11-17T11:00:07.812-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2025-D-5107-0001","allow_late_comments":false,"id":"FDA-2025-D-5107-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2025-D-5107","title":"Menstrual Products - Labeling and Performance Testing Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability"}],"document_number":"2025-19948","effective_on":null,"end_page":51373,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/11/17/2025-19948.xml","html_url":"https://www.federalregister.gov/documents/2025/11/17/2025-19948/menstrual-products-performance-testing-and-labeling-recommendations-draft-guidance-for-industry-and","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-19948?publication_date=2025-11-17","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-11-17/2025-19948/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":403,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-11-17/pdf/2025-19948.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-19948.pdf?1763127914","publication_date":"2025-11-17","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/11/17/2025-19948.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"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-2025-D-5107","supporting_documents_count":0,"docket_id":"FDA-2025-D-5107","document_id":"FDA-2025-D-5107-0001","regulation_id_number":null,"title":"Menstrual Products - Labeling and Performance Testing Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","checked_regulationsdotgov_at":"2025-11-18T18:55:10Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":51371,"subtype":null,"title":"Menstrual Products-Performance Testing and Labeling Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Menstrual ProductsPerformance Testing and Labeling Recommendations","toc_subject":"Guidance","topics":[],"type":"Notice","volume":90}