{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled \"Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis.\" This guidance document describes a means by which gene expression profiling test systems for breast cancer prognosis may comply with the requirement of special controls for class II devices. It includes recommendations for validation of performance characteristics and recommendations for product labeling. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify gene expression profiling test systems for breast cancer prognosis into class II (special controls). This guidance document is immediately in effect as the special control for gene expression profiling test systems for breast cancer prognosis, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).","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/2007/05/09/E7-8872.html","cfr_references":[],"citation":"72 FR 26398","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. 2007D-0137"],"dockets":[],"document_number":"E7-8872","effective_on":null,"end_page":26399,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2007/05/09/E7-8872.xml","html_url":"https://www.federalregister.gov/documents/2007/05/09/E7-8872/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/E7-8872?publication_date=2007-05-09","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2007-05-09/E7-8872/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":52,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2007-05-09/pdf/E7-8872.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2007-05-09","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2007/05/09/E7-8872.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-11-12T21:50:47Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":26398,"subtype":null,"title":"Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis; Availability","toc_doc":"Gene expression profiling test system for breast cancer prognosis; class II special controls","toc_subject":"Reports and guidance documents; availability, etc.:","topics":[],"type":"Notice","volume":72}