{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled \"Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300.\" This guidance document describes a means by which male condoms made of natural rubber latex (latex condoms) may comply with the requirement of special controls for class II devices. FDA believes that the labeling recommendations contained in this guidance, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of latex condoms without spermicidal lubricant. In the Federal Register of November 10, 2008 (73 FR 66522), FDA published a final rule that amended the classification regulation for condoms from class II (performance standards) to class II (special controls) and designated this guidance document as the special control for male condoms made of natural rubber latex classified under that regulation.","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/2008/12/23/E8-30586.html","cfr_references":[],"citation":"73 FR 78814","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit written or electronic 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-2004-D-0375"],"dockets":[],"document_number":"E8-30586","effective_on":null,"end_page":78816,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2008/12/23/E8-30586.xml","html_url":"https://www.federalregister.gov/documents/2008/12/23/E8-30586/guidance-for-industry-and-food-and-drug-administration-staff-class-ii-special-controls-guidance","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/E8-30586?publication_date=2008-12-23","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2008-12-23/E8-30586/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":138,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2008-12-23/pdf/E8-30586.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2008-12-23","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2008/12/23/E8-30586.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-11-15T08:38:00Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":78814,"subtype":null,"title":"Guidance for Industry and Food and Drug Administration Staff; “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300”; Availability","toc_doc":"Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300; Availability","toc_subject":"Guidance for Industry and Food and Drug Administration Staff:","topics":[],"type":"Notice","volume":73}