{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is amending certain medical device regulations to revise references and language in existing Code of Federal Regulations (CFR) provisions to conform with the final rule \"Medical Devices; Quality System Regulation Amendments\" (QMSR Final Rule). This rule does not impose any new requirements on affected parties. 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Quality Management System Regulation Technical Amendments"}],"document_number":"2025-21955","effective_on":"2026-02-02","end_page":55996,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/12/04/2025-21955.xml","html_url":"https://www.federalregister.gov/documents/2025/12/04/2025-21955/medical-devices-quality-management-system-regulation-technical-amendments","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-21955?publication_date=2025-12-04","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-12-04/2025-21955/mods.xml","not_received_for_publication":null,"page_length":19,"page_views":{"count":6869,"last_updated":"2026-05-29 12:15:10 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-12-04/pdf/2025-21955.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-21955.pdf?1764769519","publication_date":"2025-12-04","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/12/04/2025-21955.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-N-4635","supporting_documents_count":0,"docket_id":"FDA-2025-N-4635","document_id":"FDA-2025-N-4635-0001","regulation_id_number":null,"title":"Medical Devices; Quality Management System Regulation Technical Amendments","checked_regulationsdotgov_at":"2025-12-05T19:55:03Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":55978,"subtype":null,"title":"Medical Devices; Quality Management System Regulation Technical Amendments","toc_doc":"Quality Management System Regulation Technical Amendments","toc_subject":"Medical Devices","topics":["Administrative practice and procedure","Biologics","Blood","Health records","Imports","Labeling","Laboratories","Medical devices","Medical research","Ophthalmic goods and services","Packaging and containers","Radiation protection","Reporting and recordkeeping requirements","X-rays"],"type":"Rule","volume":90}