{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled \"Quality Management System Information for Certain Premarket Submission Reviews.\" The medical device current good manufacturing practice (CGMP) requirements, previously in the quality system regulation (QS regulation) and now the quality management system regulation (QMSR), have been amended effective February 2, 2026, to align more closely with the international consensus standard for devices by incorporating by reference an international standard specific for device quality management systems. This draft guidance document is intended to assist FDA staff and medical device manufacturers in understanding FDA expectations about preparing and maintaining a Quality Management System (QMS) and providing the information required to be included in certain marketing submissions regarding a QMS, in line with the QMSR. This draft guidance is not final nor is it for implementation at this time.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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/2025/11/17/2025-19947.html","cfr_references":[],"citation":"90 FR 51374","comment_url":null,"comments_close_on":"2026-01-16","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by January 16, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2025-D-4051"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2025-11-17","updated_at":"2025-11-17T11:03:51.102-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2025-D-4051-0001","allow_late_comments":false,"id":"FDA-2025-D-4051-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2025-D-4051","title":"Quality Management System Information for Certain Premarket Submission Reviews; Draft Guidance for Industry and Food and Drug Administration Staff; Availability"}],"document_number":"2025-19947","effective_on":null,"end_page":51376,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/11/17/2025-19947.xml","html_url":"https://www.federalregister.gov/documents/2025/11/17/2025-19947/quality-management-system-information-for-certain-premarket-submission-reviews-draft-guidance-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-19947?publication_date=2025-11-17","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-11-17/2025-19947/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":863,"last_updated":"2026-06-25 02:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-11-17/pdf/2025-19947.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-19947.pdf?1763127914","publication_date":"2025-11-17","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/11/17/2025-19947.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-D-4051","supporting_documents_count":0,"docket_id":"FDA-2025-D-4051","document_id":"FDA-2025-D-4051-0001","regulation_id_number":null,"title":"Quality Management System Information for Certain Premarket Submission Reviews; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","checked_regulationsdotgov_at":"2025-11-18T18:55:10Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":51374,"subtype":null,"title":"Quality Management System Information for Certain Premarket Submission Reviews; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Quality Management System Information for Certain Premarket Submission Reviews","toc_subject":"Guidance","topics":[],"type":"Notice","volume":90}