{"id":31645,"date":"2024-02-23T08:00:32","date_gmt":"2024-02-23T07:00:32","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=31645"},"modified":"2024-02-21T15:45:22","modified_gmt":"2024-02-21T14:45:22","slug":"usa-quality-management-system-for-medical-devices-will-follow-iso13485","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2024\/02\/23\/usa-quality-management-system-for-medical-devices-will-follow-iso13485\/","title":{"rendered":"USA: Quality Management System for Medical Devices Will Follow ISO13485"},"content":{"rendered":"<h2>On February 2, the FDA published the Quality Management System Regulation (<strong>QMSR<\/strong>) Final Rule on its official website, amending the current Good Manufacturing Practice (<strong>GMP<\/strong>) requirements of the Quality System Regulation (<a href=\"https:\/\/www.govinfo.gov\/content\/pkg\/FR-2024-02-02\/pdf\/2024-01709.pdf\"><em>21 CFR Part 820<\/em><\/a>) by incorporating ISO 13485 by reference.<\/h2>\n<p>This represents a very important step towards greater <strong>harmonisation<\/strong> of US regulations with the <strong>international context<\/strong>. Specifically, the law brings <strong>US <\/strong>medical devices quality management requirements closer to those of other markets such as <strong>the European Union, Japan and Australia<\/strong>, where quality standards are primarily based on ISO 13485.<\/p>\n<p>The law will come into force on <strong>February 2, 2026 <\/strong>and, therefore, manufacturers have two years to align internal processes and procedures, make appropriate changes within their organisations and update documentation according to the requirements of the QMSR Regulation.<\/p>\n<p>However, the FDA confirms that compliance with<strong> ISO 13485<\/strong> alone does<strong> not fully meet the requirements of the QMSR Regulation<\/strong> and has included additional <strong>requirements<\/strong> to be met in addition to ISO 13485 in the law. For example, the FDA argues that ISO 13485 does not specifically address the inspection of <strong>labelling<\/strong> and <strong>packaging<\/strong> by the manufacturer, and consequently, the requirements of the QMSR Regulation that strengthen controls for labelling and packaging operations are retained in the law.<\/p>\n<p>Furthermore, the FDA does not currently oblige manufacturers to show management audit logs, internal quality audit reports and supplier audit reports to inspectors. However, it removed this exception in the latest law because it considers that it does not apply to manufacturers inspected by other regulatory bodies or audited by other bodies such as, for example, Medical Device Single Audit Programme (MDSAP) audit organisations.<\/p>\n<p>In conclusion, FDA intends to align the <strong>US regulatory framework<\/strong> with that of other countries around the world to promote regulatory compliance of devices and provide a faster introduction of safe, effective, high-quality devices for US patients.<\/p>\n<p>&nbsp;<\/p>\n<p>&gt;&gt;&gt;\u00a0Through the services of <a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/consulenza-strategico-regolatoria-dispositivi-medici-medical-devices\/\"><strong>strategic-regulatory consulting<\/strong><\/a>, <a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/registrazioni-internazionali-extra-ue-dispositivi-medici-dm-e-medico-diagnostici-in-vitro-ivd\/\"><strong>510(k) pre-market notification, De Novo and Premarket approval (PMA)<\/strong><\/a> drafting, Thema is the ideal partner to market medical devices in the U.S.A. while complying with FDA requirements.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Source<\/strong><\/p>\n<p><a href=\"https:\/\/www.federalregister.gov\/documents\/2024\/02\/02\/2024-01709\/medical-devices-quality-system-regulation-amendments\">Medical Devices; Quality System Regulation Amendments<\/a><\/p>\n<p><a href=\"https:\/\/www.govinfo.gov\/content\/pkg\/FR-2024-02-02\/pdf\/2024-01709.pdf\">21 CFR Parts 4 and 820<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On February 2, the FDA published the Quality Management System Regulation (QMSR) Final Rule on its official website, amending the current  [&#8230;]<\/p>\n","protected":false},"author":115,"featured_media":31625,"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":[2],"tags":[],"class_list":["post-31645","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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