{"abstract":"The Food and Drug Administration (FDA or Agency) is correcting a final rule that appeared in the Federal Register on February 2, 2024. In that final rule, FDA amended the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation to harmonize and modernize the device CGMP. FDA is correcting an editorial error that inadvertently omitted a definition in the codified of the final rule. This action is editorial in nature and is intended to ensure the accuracy and clarity of the Agency's regulations.","action":"Final rule; correction.","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/2024/10/15/2024-23701.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"820","title":21}],"citation":"89 FR 82945","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Effective February 2, 2026.","disposition_notes":null,"docket_ids":["Docket No. FDA-2021-N-0507"],"dockets":[{"supporting_documents":[{"title":"Tab A - FRIA-OMB Original Version","document_id":"FDA-2021-N-0507-0090"},{"title":"Tab A - Final Rule-OMB Original Version","document_id":"FDA-2021-N-0507-0089"},{"title":"Reference 11 - International Standard, ISO 9000 ‘‘Quality Management Systems - Fundamentals and Vocabulary,’’ ISO 9000:2015; 4th Ed., September 15, 2015. (Available at: ISO 9000:2015(en), Quality management systems -Fundamentals","document_id":"FDA-2021-N-0507-0086"},{"title":"Reference 2 - FDA, ‘‘Regulations Establishing Good Manufacturing Practices for the Manufacture, Packing, Storage, and Installation of Medical Devices.’’ Federal Register, 43: 31508–31532, July 21, 1978.","document_id":"FDA-2021-N-0507-0085"},{"title":"Reference 1 - ISO 13485:2016, ‘‘Medical devices - Quality management systems -Requirements for regulatory purposes,’’ 3rd Ed., March 1, 2016.","document_id":"FDA-2021-N-0507-0084"},{"title":"11 - Reference 10 - ISO 9000-2015","document_id":"FDA-2021-N-0507-0037"},{"title":"12 - Reference 11 - Preliminary Regulatory Impact Analysis","document_id":"FDA-2021-N-0507-0035"},{"title":"10 - Reference 9 - International Medical Device Regulators Forum","document_id":"FDA-2021-N-0507-0034"},{"title":"09 - Reference 8 - MDSAP Voluntary Audit Report Pilot 80FR78741","document_id":"FDA-2021-N-0507-0033"},{"title":"08 - Reference 7 - ISO 14971-2019","document_id":"FDA-2021-N-0507-0032"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":null,"updated_at":"2024-10-15T10:56:14.773-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2021-N-0507-0087","allow_late_comments":false,"id":"FDA-2021-N-0507-0087","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":17,"id":"FDA-2021-N-0507","title":"Medical Devices; Quality System Regulation Amendments"}],"document_number":"2024-23701","effective_on":"2026-02-02","end_page":82945,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/10/15/2024-23701.xml","html_url":"https://www.federalregister.gov/documents/2024/10/15/2024-23701/medical-devices-quality-system-regulation-amendments-correction","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-23701?publication_date=2024-10-15","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-10-15/2024-23701/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":21924,"last_updated":"2026-10-24 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-10-15/pdf/2024-23701.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-23701.pdf?1728650748","publication_date":"2024-10-15","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/10/15/2024-23701.txt","regulation_id_number_info":{"0910-AH99":{"issue":"202310","html_url":"https://www.federalregister.gov/regulations/0910-AH99/medical-devices-quality-system-regulation-amendments","title":"Medical Devices; Quality System Regulation Amendments","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202310&RIN=0910-AH99&operation=OPERATION_EXPORT_XML","priority_category":"Section 3(f)(1) Significant"}},"regulation_id_numbers":["0910-AH99"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Tab A - FRIA-OMB Original Version","document_id":"FDA-2021-N-0507-0090"},{"title":"Tab A - Final Rule-OMB Original Version","document_id":"FDA-2021-N-0507-0089"},{"title":"Reference 11 - International Standard, ISO 9000 ‘‘Quality Management Systems - Fundamentals and Vocabulary,’’ ISO 9000:2015; 4th Ed., September 15, 2015. (Available at: ISO 9000:2015(en), Quality management systems -Fundamentals","document_id":"FDA-2021-N-0507-0086"},{"title":"Reference 2 - FDA, ‘‘Regulations Establishing Good Manufacturing Practices for the Manufacture, Packing, Storage, and Installation of Medical Devices.’’ Federal Register, 43: 31508–31532, July 21, 1978.","document_id":"FDA-2021-N-0507-0085"},{"title":"Reference 1 - ISO 13485:2016, ‘‘Medical devices - Quality management systems -Requirements for regulatory purposes,’’ 3rd Ed., March 1, 2016.","document_id":"FDA-2021-N-0507-0084"},{"title":"11 - Reference 10 - ISO 9000-2015","document_id":"FDA-2021-N-0507-0037"},{"title":"12 - Reference 11 - Preliminary Regulatory Impact Analysis","document_id":"FDA-2021-N-0507-0035"},{"title":"10 - Reference 9 - International Medical Device Regulators Forum","document_id":"FDA-2021-N-0507-0034"},{"title":"09 - Reference 8 - MDSAP Voluntary Audit Report Pilot 80FR78741","document_id":"FDA-2021-N-0507-0033"},{"title":"08 - Reference 7 - ISO 14971-2019","document_id":"FDA-2021-N-0507-0032"}],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/0910-AH99/medical-devices-quality-system-regulation-amendments","title":"Medical Devices; Quality System Regulation Amendments"},"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-2021-N-0507","supporting_documents_count":17,"docket_id":"FDA-2021-N-0507","document_id":"FDA-2021-N-0507-0087","regulation_id_number":"0910-AH99","title":"Medical Devices; Quality System Regulation Amendments","checked_regulationsdotgov_at":"2024-10-16T14:00:17Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":82945,"subtype":null,"title":"Medical Devices; Quality System Regulation Amendments; Correction","toc_doc":"Quality System; Correction","toc_subject":"Medical Devices","topics":[],"type":"Rule","volume":89}