{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule to update the mammography regulations that were issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). We are issuing updates to modernize the regulations by incorporating current science and mammography best practices. These updates are intended to improve the delivery of mammography services by strengthening the communication of healthcare information; allowing for more informed decision making by patients and providers (by requiring facilities to provide them with additional health information); helping to ensure the availability of qualified mammography personnel; bolstering the medical outcomes audit to provide feedback to improve mammography interpretations; modernizing technological aspects of the standards; and adding additional tools to deal with noncompliant facilities.","action":"Final rule.","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/2023/03/10/2023-04550.html","cfr_references":[{"chapter":null,"citation_url":null,"part":900,"title":21}],"citation":"88 FR 15126","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective on September 10, 2024.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-N-0134"],"dockets":[{"supporting_documents":[{"title":"Tab C - Rule - OMB final version","document_id":"FDA-2013-N-0134-0197"},{"title":"Tab C - FRIA - OMB final version","document_id":"FDA-2013-N-0134-0196"},{"title":"Tab B - Final Rule - Comparison OMB original to final version","document_id":"FDA-2013-N-0134-0194"},{"title":"Tab A - FRIA - OMB original version","document_id":"FDA-2013-N-0134-0193"},{"title":"Tab A - Final Rule - OMB original version","document_id":"FDA-2013-N-0134-0192"},{"title":"MQSA Ref 34 Eastern Research Group Inc. - Baseline Quality Measures","document_id":"FDA-2013-N-0134-0186"},{"title":"MQSA Ref 31 - ACR BI-RADS pp 7-8","document_id":"FDA-2013-N-0134-0184"},{"title":"MQSA Ref 27 - Ho 2014 AJR","document_id":"FDA-2013-N-0134-0180"},{"title":"MQSA Ref 23 - MQSA Alternative Standard 11_ Modifica","document_id":"FDA-2013-N-0134-0176"},{"title":"MQSA Ref 22 - Transcript of Sept 29 2006 - 2nd part","document_id":"FDA-2013-N-0134-0175"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2023-03-10","updated_at":"2023-03-10T09:56:33.806-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2013-N-0134-0190","allow_late_comments":null,"id":"FDA-2013-N-0134-0190","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":45,"id":"FDA-2013-N-0134","title":"Mammography Quality Standards Act Requirements"}],"document_number":"2023-04550","effective_on":"2024-09-10","end_page":15171,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/03/10/2023-04550.xml","html_url":"https://www.federalregister.gov/documents/2023/03/10/2023-04550/mammography-quality-standards-act","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-04550?publication_date=2023-03-10","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-03-10/2023-04550/mods.xml","not_received_for_publication":null,"page_length":46,"page_views":{"count":46775,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-03-10/pdf/2023-04550.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-04550.pdf?1678369517","publication_date":"2023-03-10","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/03/10/2023-04550.txt","regulation_id_number_info":{"0910-AH04":{"issue":"202210","html_url":"https://www.federalregister.gov/regulations/0910-AH04/mammography-quality-standards-act","title":"Mammography Quality Standards Act","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202210&RIN=0910-AH04&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AH04"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Tab C - Rule - OMB final version","document_id":"FDA-2013-N-0134-0197"},{"title":"Tab C - FRIA - OMB final version","document_id":"FDA-2013-N-0134-0196"},{"title":"Tab B - Final Rule - Comparison OMB original to final version","document_id":"FDA-2013-N-0134-0194"},{"title":"Tab A - FRIA - OMB original version","document_id":"FDA-2013-N-0134-0193"},{"title":"Tab A - Final Rule - OMB original version","document_id":"FDA-2013-N-0134-0192"},{"title":"MQSA Ref 34 Eastern Research Group Inc. - Baseline Quality Measures","document_id":"FDA-2013-N-0134-0186"},{"title":"MQSA Ref 31 - ACR BI-RADS pp 7-8","document_id":"FDA-2013-N-0134-0184"},{"title":"MQSA Ref 27 - Ho 2014 AJR","document_id":"FDA-2013-N-0134-0180"},{"title":"MQSA Ref 23 - MQSA Alternative Standard 11_ Modifica","document_id":"FDA-2013-N-0134-0176"},{"title":"MQSA Ref 22 - Transcript of Sept 29 2006 - 2nd part","document_id":"FDA-2013-N-0134-0175"}],"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-2013-N-0134","supporting_documents_count":45,"docket_id":"FDA-2013-N-0134","document_id":"FDA-2013-N-0134-0190","regulation_id_number":null,"title":"Mammography Quality Standards Act Requirements","checked_regulationsdotgov_at":"2023-03-21T17:55:09Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":15126,"subtype":null,"title":"Mammography Quality Standards Act","toc_doc":"Mammography Quality Standards Act","toc_subject":null,"topics":["Electronic products","Health facilities","Medical devices","Radiation protection","Reporting and recordkeeping requirements","X-rays"],"type":"Rule","volume":88}