{"id":34929,"date":"2025-12-02T10:25:06","date_gmt":"2025-12-02T09:25:06","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=34929"},"modified":"2025-12-03T11:03:06","modified_gmt":"2025-12-03T10:03:06","slug":"the-new-fda-qmsr-aligned-with-iso-13485-what-changes","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2025\/12\/02\/the-new-fda-qmsr-aligned-with-iso-13485-what-changes\/","title":{"rendered":"The New FDA QMSR Aligned with ISO 13485: What Changes?"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1144px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><p>The new <strong>Quality Management System Regulation (QMSR)<\/strong> comes into effect on <strong>February 2, 2026<\/strong>, following the publication of the <a href=\"https:\/\/www.federalregister.gov\/documents\/2024\/02\/02\/2024-01709\/medical-devices-quality-system-regulation-amendments\"><strong>Final Rule<\/strong><\/a> on February 2, 2024, which amends the previous <a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-H\/part-820\"><strong>21 CFR Part 820<\/strong><\/a><strong> \u2013 Quality System Regulation (QSR)<\/strong>.<\/p>\n<p>This is one of the most significant regulatory updates in recent decades for those placing Medical Devices on the U.S. market.<\/p>\n<p>The objective of the reform is clear: <strong>to harmonize the requirements of the Current Good Manufacturing Practice (cGMP) for Medical Devices with the international standard<\/strong> <strong>ISO 13485:2016<\/strong>.<\/p>\n<p>With the QMSR, the FDA rewrites Part 820 by incorporating <strong>ISO 13485:2016 by reference<\/strong>, adopting its structure and main requirements. This approach reflects the FDA&#8217;s strategy to simplify the regulatory framework and promote global harmonization, reducing the differences between the obligations required in the United States and those mandated by other regulatory authorities.<\/p>\n<h3><strong>What is the QMSR and its Role in Harmonization?<\/strong><\/h3>\n<p>The QMSR <strong>replaces the previous<\/strong> <strong>21 CFR Part 820<\/strong> and incorporates the <strong>2016 edition of the ISO 13485:2016 standard<\/strong> by reference. The update pursues the FDA&#8217;s aims for regulatory simplicity and global harmonization because it adopts the quality management system requirements used by numerous other regulatory authorities worldwide.<\/p>\n<h3><strong>Strategic Objectives and Benefits<\/strong><\/h3>\n<ul>\n<li><strong>Global Harmonization<\/strong><\/li>\n<\/ul>\n<p>Alignment with ISO 13485:2016 strengthens participation in the <strong>MDSAP<\/strong> (Medical Device Single Audit Program), which includes Canada, Australia, Brazil, and Japan. This alignment of the U.S. Quality Management System is also valuable for the <strong>European Union<\/strong>: companies already compliant with ISO 13485:2016 for the European MDR will see the <strong>conformity path<\/strong> to the American market <strong>accelerated and simplified<\/strong>. Essentially, harmonization speeds up conformity procedures and market access in multiple countries simultaneously.<\/p>\n<ul>\n<li><strong>Reduced Burden<\/strong><\/li>\n<\/ul>\n<p>Official FDA estimates indicate an <strong>annualized net cost savings (benefits)<\/strong> of approximately $532 million (7% discount rate) or $554 million (3% discount rate), thanks to the possibility of maintaining a single quality system for multiple markets.<\/p>\n<ul>\n<li><strong>Maximization of Inspection Resources<\/strong><\/li>\n<\/ul>\n<p>Harmonization allows for greater efficiency in allocating inspection resources. If a company already has a robust QMS based on ISO 13485:2016, FDA inspectors can focus on FDA-specific critical areas.<\/p>\n<ul>\n<li><strong>Market Access and Benefits<\/strong><\/li>\n<\/ul>\n<p>A more efficient and globally recognized Quality Management System ensures that manufacturers (U.S. and non-U.S.) can place <strong>safe and effective<\/strong> Medical Devices on the market, bringing clinical benefits to patients <strong>more quickly and predictably<\/strong>.<\/p>\n<h3><strong>Key Points of Integration <\/strong><\/h3>\n<p>The core of the change is the direct incorporation of <strong>ISO 13485:2016<\/strong> into the structure of the new Quality Management System Regulation (QMSR), which adds specific supplementary sections (e.g., \u00a7820.7, \u00a7820.10, \u00a7820.35, \u00a7820.45).<\/p>\n<ol>\n<li><strong> Emphasis on Risk and the Life Cycle<\/strong><\/li>\n<\/ol>\n<p>While the risk approach in 21 CFR 820 was only partially explicit, the QMSR makes it central to the entire quality system.<\/p>\n<ul>\n<li>The <strong>Risk Management<\/strong> process must be extended throughout the entire product life cycle.<\/li>\n<li>Conformity to the <strong>ISO 14971<\/strong> standard is recognized as a tool to document product risk management.<\/li>\n<\/ul>\n<ol start=\"2\">\n<li><strong> Explicit Controls on the Quality Management System and Audits<\/strong><\/li>\n<\/ol>\n<p>The Quality Management System Regulation (QMSR) explicitly details requirements that were less detailed in the previous 21 CFR QSR.<\/p>\n<ul>\n<li><strong>QMS Implementation:<\/strong> The requirement to implement a Quality Management System is explicitly stated (\u00a7820.10).<\/li>\n<li><strong>Internal Audits and Management Review:<\/strong> Internal Audits and Management Review are made explicit requirements (consistent with ISO 13485:2016) and, unlike the QSR, the related reports are now <strong>fully subject to FDA inspection<\/strong>.<\/li>\n<li><strong>Document Control:<\/strong> Control over documents and records is aligned with ISO 13485:2016, with a dedicated section (\u00a7820.35) that also integrates FDA-specific requirements.<\/li>\n<\/ul>\n<ol start=\"3\">\n<li><strong> Customer Satisfaction and Improvement<\/strong><\/li>\n<\/ol>\n<p>These two aspects, pillars of ISO 13485:2016, take on crucial importance.<\/p>\n<ul>\n<li>The concept of <strong>Customer Satisfaction<\/strong> requires the QMS not only to manage complaints but to actively use feedback to monitor device performance.<\/li>\n<li>The <strong>Continuous Improvement<\/strong> of the QMS becomes a fundamental element for demonstrating the quality system&#8217;s effectiveness over time.<\/li>\n<\/ul>\n<ol start=\"4\">\n<li><strong> Record Management and Documentation<\/strong><\/li>\n<\/ol>\n<p>Control over documents and records is aligned with ISO 13485:2016 but integrated with specific FDA needs, particularly in the new section \u00a7820.35.<\/p>\n<ul>\n<li>Although the old acronyms <strong>DMR<\/strong> (Device Master Record), <strong>DHR<\/strong> (Device History Record), and <strong>DHF<\/strong> (Design History File) are no longer explicitly mentioned in the QMSR, the substantial requirements are maintained and covered by the documented structure provided by ISO 13485:2016, which includes the <strong>Medical Device File<\/strong> and traceability and development records.<\/li>\n<li>The QMSR, through \u00a7820.35, clarifies that records must include documentation related to <strong>Adverse Events and Recalls<\/strong> and clarifies aspects of confidentiality and protection of information.<\/li>\n<li>The new section \u00a7820.45 introduces additional controls on <strong>Labeling and Packaging<\/strong>, requiring procedures that ensure the visual verification of labels for accuracy, a more stringent requirement than mere automation.<\/li>\n<\/ul>\n<h3><strong>Impact and Strategy: What to Do? <\/strong><\/h3>\n<p><strong>February 2, 2026<\/strong>, is the final deadline by which the <strong>Quality Management System (QMS)<\/strong> must be <strong>fully aligned<\/strong> with the requirements of the new QMSR, based on <strong>ISO 13485:2016<\/strong>.<\/p>\n<p>Manufacturers placing Medical Devices in the United States who have <strong>only<\/strong> followed <strong>21 CFR Part 820<\/strong> must adapt their Quality Management System.<\/p>\n<p><strong>This is not a new implementation from scratch<\/strong>. However, <strong>an accurate internal review (Gap Assessment)<\/strong> is essential.<\/p>\n<p>While companies already compliant with ISO 13485:2016 have a significant advantage, those who have operated exclusively under 21 CFR Part 820 must carefully check the differences, focusing in particular on:<\/p>\n<ul>\n<li><strong>Risk management<\/strong>;<\/li>\n<li><strong>QMS documentation and related definitions<\/strong>;<\/li>\n<li><strong>Customer satisfaction<\/strong>;<\/li>\n<li><strong>Continuous improvement of the QMS<\/strong>.<\/li>\n<\/ul>\n<h3><strong>Next Steps <\/strong><\/h3>\n<ol>\n<li><strong>Perform a Gap Assessment:<\/strong> Compare internal processes with QMSR\/ISO 13485:2016 requirements.<\/li>\n<li><strong>Update Documentation:<\/strong> Review procedures to reflect ISO terminology.<\/li>\n<li><strong>Prepare for Inspections:<\/strong> Be ready for FDA inspections that will examine the Quality Management System comprehensively, including internal audit records.<\/li>\n<\/ol>\n<h3><strong>FDA Draft Guidance<\/strong><\/h3>\n<p>In October 2025, the FDA published <strong>a Draft Guidance<\/strong> titled <strong>&#8220;Quality Management System Information for Certain Premarket Submission Reviews.&#8221;<\/strong><\/p>\n<p>This document, open for public comment and not yet final, provides clarifications on the QMS information (based on ISO 13485:2016 terminology) that must be included in <strong>PMA<\/strong> and <strong>HDE<\/strong> approval requests. The document reinforces FDA&#8217;s expectations, particularly concerning <strong>internal audit<\/strong> records, which become accessible to inspectors with the QMSR. Official guidelines are awaited.<\/p>\n<p>&gt;&gt;&gt; <em>Thema offers full <a href=\"https:\/\/www.thema-med.com\/en\/services\/quality-and-international-gmps\/\">support<\/a> in <strong>gap analysis<\/strong> and the implementation of necessary actions to ensure <strong>full compliance with the new QMSR<\/strong> (Quality Management System Regulation), guaranteeing operational continuity and access to the U.S. market.<\/em><\/p>\n<p><strong>SOURCES:<\/strong><br \/><a href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-2024-02-02\/2024-01709\">https:\/\/www.govinfo.gov\/app\/details\/FR-2024-02-02\/2024-01709<\/a><\/p>\n<p><a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/quality-management-system-information-certain-premarket-submission-reviews\">Quality Management System Information for Certain Premarket Submission Reviews | FDA<\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"featured_media":34930,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[679],"tags":[2000,2091,2090,2092,340,2089],"class_list":["post-34929","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog-en","tag-eifu-en","tag-iso-15223-en","tag-iso-20417-en","tag-labelling-en-2","tag-mdr-2","tag-mdr"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>The New FDA QMSR Aligned with ISO 13485: What Changes? 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