{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation to harmonize and modernize the regulation. We are harmonizing to align more closely with the international consensus standard for devices by converging with the quality management system (QMS) requirements used by other regulatory authorities from other jurisdictions (i.e., other countries). We are doing so by incorporating by reference an international standard specific for device quality management systems. Through this rulemaking we also establish additional requirements and make conforming edits to clarify the device CGMP requirements for such products. This action will continue our efforts to align our regulatory framework with that used by regulatory authorities in other jurisdictions to promote consistency in the regulation of devices and provide timelier introduction of safe, effective, high-quality devices for patients.","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/2024/02/02/2024-01709.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"4","title":21},{"chapter":null,"citation_url":null,"part":"820","title":21}],"citation":"89 FR 7496","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective February 2, 2026. The incorporation by reference of certain material listed in this rule is approved by the Director of the Federal Register 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. 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