{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled \"Recommendations for Labeling Medical Products to Inform Users That the Product or Product Container Is Not Made With Natural Rubber Latex; Guidance for Industry and Food and Drug Administration Staff.\" The purpose of this guidance is to make recommendations on the appropriate language to include in the labeling of a medical product to convey that natural rubber latex was not used as a material in the manufacture of the product, product container, and/or packaging. FDA is concerned that statements submitted for inclusion in medical product labeling, such as \"latex-free,\" \"does not contain natural rubber latex,\" or \"does not contain latex\" are not accurate because it is not possible to reliably assure that there is a complete absence of the allergens associated with hypersensitivity reactions to natural rubber latex in the medical product.","action":"Notice.","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/2014/12/02/2014-28265.html","cfr_references":[],"citation":"79 FR 71436","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-D-0168"],"dockets":[],"document_number":"2014-28265","effective_on":null,"end_page":71437,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/12/02/2014-28265.xml","html_url":"https://www.federalregister.gov/documents/2014/12/02/2014-28265/recommendations-for-labeling-medical-products-to-inform-users-that-the-product-or-product-container","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-28265?publication_date=2014-12-02","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-12-02/2014-28265/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":15292,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-12-02/pdf/2014-28265.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-28265.pdf?1417468475","publication_date":"2014-12-02","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/12/02/2014-28265.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2013-D-0168","supporting_documents_count":0,"docket_id":"FDA-2013-D-0168","regulation_id_number":null,"title":"Draft Guidance for Industry and FDA Staff: Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex; Availability","checked_regulationsdotgov_at":"2015-01-12T19:20:13Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":71436,"subtype":null,"title":"Recommendations for Labeling Medical Products To Inform Users That the Product or Product Container Is Not Made With Natural Rubber Latex; Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is Not Made with Natural Rubber Latex","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":79}