{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation 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 propose to do so through incorporating by reference an international standard specific for device quality management systems set by the International Organization for Standardization (ISO), the 2016 edition of ISO 13485 (ISO 13485). Through this rulemaking we also propose additional requirements to align with existing requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations, and make conforming edits to the Code of Federal Regulations (CFR) to clarify the device CGMP requirements for combination products. This action, if finalized, will continue our efforts to align our regulatory framework with that used by other regulatory authorities to promote consistency in the regulation of devices and provide timelier introduction of safe, effective, high- quality devices for patients.","action":"Proposed 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/2022/02/23/2022-03227.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"4","title":21},{"chapter":null,"citation_url":null,"part":"820","title":21}],"citation":"87 FR 10119","comment_url":null,"comments_close_on":"2022-05-24","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the proposed rule by May 24, 2022. Submit written comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 (PRA) by March 25, 2022.","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":74,"comment_start_date":"2022-02-23","updated_at":"2023-02-28T12:26:35.727-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2021-N-0507-0001","allow_late_comments":null,"id":"FDA-2021-N-0507-0001","comment_end_date":"2022-05-25","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":"2022-03227","effective_on":null,"end_page":10134,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/02/23/2022-03227.xml","html_url":"https://www.federalregister.gov/documents/2022/02/23/2022-03227/medical-devices-quality-system-regulation-amendments","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-03227?publication_date=2022-02-23","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-02-23/2022-03227/mods.xml","not_received_for_publication":null,"page_length":16,"page_views":{"count":57587,"last_updated":"2026-10-22 16:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-02-23/pdf/2022-03227.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-03227.pdf?1645537512","publication_date":"2022-02-23","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/02/23/2022-03227.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":74,"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-0507-0001","regulation_id_number":"0910-AH99","title":"Medical Devices; Quality System Regulation Amendments","checked_regulationsdotgov_at":"2023-02-28T17:26:34Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":10119,"subtype":null,"title":"Medical Devices; Quality System Regulation Amendments","toc_doc":"Quality System Regulation","toc_subject":"Medical Devices:\n","topics":["Biologics","Drugs","Human cells and tissue-based products","Incorporation by reference","Medical devices","Reporting and recordkeeping requirements"],"type":"Proposed Rule","volume":87}