{"id":8152,"date":"2024-01-12T03:23:44","date_gmt":"2024-01-12T03:23:44","guid":{"rendered":"https:\/\/www.orielstat.com\/blog\/?p=8152"},"modified":"2024-01-12T19:56:49","modified_gmt":"2024-01-12T19:56:49","slug":"samd-simd-regulatory-requirements","status":"publish","type":"post","link":"https:\/\/www.orielstat.com\/blog\/samd-simd-regulatory-requirements\/","title":{"rendered":"FDA Regulatory Requirements for Medical Device Software (SaMD and SiMD)"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"8152\" class=\"elementor elementor-8152\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7388bb3 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7388bb3\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-4264d41\" data-id=\"4264d41\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-d04a716 blog-details-page elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"d04a716\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-66 elementor-top-column elementor-element elementor-element-e193c4d\" data-id=\"e193c4d\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-aa22ff3 elementor-widget elementor-widget-post-info\" data-id=\"aa22ff3\" data-element_type=\"widget\" data-widget_type=\"post-info.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/elementor\/css\/custom-widget-icon-list.min.css?ver=0\"><link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/plugins\/elementor-pro\/assets\/css\/widget-theme-elements.min.css\">\t\t<ul class=\"elementor-inline-items elementor-icon-list-items elementor-post-info\">\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item elementor-repeater-item-7f6be35 elementor-inline-item\" itemprop=\"datePublished\">\n\t\t\t\t\t\t<a href=\"https:\/\/www.orielstat.com\/blog\/2024\/01\/12\/\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-date\">\n\t\t\t\t\t\t\t\t\t\tJanuary 12, 2024\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t<\/li>\n\t\t\t\t<\/ul>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-25cfb2d elementor-widget elementor-widget-heading\" data-id=\"25cfb2d\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h1 class=\"elementor-heading-title elementor-size-default\">FDA Regulatory Requirements for Medical Device Software (SaMD and SiMD)\n<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-78a7c7e elementor-widget elementor-widget-image\" data-id=\"78a7c7e\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"2475\" height=\"1392\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/07\/software-reg-requirements-li.jpg\" class=\"attachment-full size-full wp-image-4799\" alt=\"\" loading=\"lazy\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/07\/software-reg-requirements-li.jpg 2475w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/07\/software-reg-requirements-li-300x169.jpg 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/07\/software-reg-requirements-li-1024x576.jpg 1024w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/07\/software-reg-requirements-li-768x432.jpg 768w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/07\/software-reg-requirements-li-1536x864.jpg 1536w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/07\/software-reg-requirements-li-2048x1152.jpg 2048w\" sizes=\"(max-width: 2475px) 100vw, 2475px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f7a5edb elementor-widget elementor-widget-text-editor\" data-id=\"f7a5edb\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p>Let\u2019s start with US FDA requirements.<\/p><p>\u00a0<\/p><h3>How Does US FDA Regulate Medical Device Software?<\/h3><p>FDA is years ahead of other regulators, including Europe, when it comes to the specificity of regulatory guidance pertaining to medical device software. FDA has been publishing software guidance documents for more than 20 years and has been especially prolific in the last 3 to 5 years. To their credit, FDA recognizes the importance (and prevalence) of software in all sorts of devices and is making a concerted effort to ensure that its regulatory framework does not stifle innovation. In recent years, new or updated guidance has been published covering all sorts of issues, including:<\/p><ul><li>Plus, several more! See the entire list\u00a0<a href=\"https:\/\/www.orielstat.com\/blog\/medical-device-software-standards\/\" target=\"_blank\" rel=\"noopener noreferrer\">know more<\/a>.<\/li><\/ul><p>FDA guidance is not the only thing you should follow. A variety of international standards go even further into the weeds on topics such as medical device cybersecurity, interoperability, life-cycle management, and more.<\/p><h3>\u00a0<\/h3><h3>FDA Requirements for Off-the-Shelf (OTS) Medical Device Software<\/h3><p>Off-The-Shelf Software Use in Medical Devices:\u00a0<span class=\"article-subtitle text-center\">Guidance for Industry and Food and Drug Administration Staff,\u00a0<\/span>SEPTEMBER 2019<\/p><p>\u00a0<\/p><h3>How Does Europe Regulate Medical Device Software?<\/h3><p>Other software guidance documents published by the European Commission include:<\/p><h3>\u00a0<\/h3><h3>Want to Learn More?<\/h3><p>This article has only scratched the surface of the regulations that pertain to medical device software in the US and Europe. Take the next step with our in-depth training class on\u00a0<a href=\"https:\/\/www.orielstat.com\/courses\/Software-Regulations-Standards-Training-Medical-Devices\" target=\"_blank\" rel=\"noopener noreferrer\">medical device software regulations and standards<\/a>. 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Device Software (SaMD and SiMD) Let\u2019s start with US FDA requirements. \u00a0 How Does US FDA Regulate Medical Device Software? FDA is years ahead of other regulators, including Europe, when it comes to the specificity of regulatory guidance pertaining to medical device software. FDA has been publishing software guidance documents [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":4799,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":[],"categories":[65],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.7 (Yoast SEO v21.7) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\r\n<title>Oriel STAT A MATRIX &#8211; ELIQUENT Life Sciences Blog<\/title>\r\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\r\n<link rel=\"canonical\" href=\"https:\/\/www.orielstat.com\/blog\/samd-simd-regulatory-requirements\/\" \/>\r\n<meta property=\"og:locale\" content=\"en_US\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:description\" content=\"FDA Regulatory Requirements for Medical Device Software (SaMD and SiMD) Let\u2019s start with US FDA requirements. \u00a0 How Does US FDA Regulate Medical Device Software? 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FDA has been publishing software guidance documents [&hellip;]\" \/>\r\n<meta property=\"og:url\" content=\"https:\/\/www.orielstat.com\/blog\/samd-simd-regulatory-requirements\/\" \/>\r\n<meta property=\"og:site_name\" content=\"Oriel STAT A MATRIX - ELIQUENT Life Sciences Blog\" \/>\r\n<meta property=\"article:published_time\" content=\"2024-01-12T03:23:44+00:00\" \/>\r\n<meta property=\"article:modified_time\" content=\"2024-01-12T19:56:49+00:00\" \/>\r\n<meta property=\"og:image\" content=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/07\/software-reg-requirements-li.jpg\" \/>\r\n\t<meta property=\"og:image:width\" content=\"2475\" \/>\r\n\t<meta property=\"og:image:height\" content=\"1392\" \/>\r\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\r\n<meta name=\"author\" content=\"usr192162\" \/>\r\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\r\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"usr192162\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\r\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Oriel STAT A MATRIX &#8211; ELIQUENT Life Sciences Blog","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.orielstat.com\/blog\/samd-simd-regulatory-requirements\/","og_locale":"en_US","og_type":"article","og_description":"FDA Regulatory Requirements for Medical Device Software (SaMD and SiMD) Let\u2019s start with US FDA requirements. \u00a0 How Does US FDA Regulate Medical Device Software? FDA is years ahead of other regulators, including Europe, when it comes to the specificity of regulatory guidance pertaining to medical device software. FDA has been publishing software guidance documents [&hellip;]","og_url":"https:\/\/www.orielstat.com\/blog\/samd-simd-regulatory-requirements\/","og_site_name":"Oriel STAT A MATRIX - ELIQUENT Life Sciences Blog","article_published_time":"2024-01-12T03:23:44+00:00","article_modified_time":"2024-01-12T19:56:49+00:00","og_image":[{"width":2475,"height":1392,"url":"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/07\/software-reg-requirements-li.jpg","type":"image\/jpeg"}],"author":"usr192162","twitter_card":"summary_large_image","twitter_misc":{"Written by":"usr192162","Est. reading time":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.orielstat.com\/blog\/samd-simd-regulatory-requirements\/#article","isPartOf":{"@id":"https:\/\/www.orielstat.com\/blog\/samd-simd-regulatory-requirements\/"},"author":{"name":"usr192162","@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/person\/a775f07c9602a3521143e80692594553"},"headline":"FDA Regulatory Requirements for Medical Device Software (SaMD and SiMD)","datePublished":"2024-01-12T03:23:44+00:00","dateModified":"2024-01-12T19:56:49+00:00","mainEntityOfPage":{"@id":"https:\/\/www.orielstat.com\/blog\/samd-simd-regulatory-requirements\/"},"wordCount":297,"publisher":{"@id":"https:\/\/www.orielstat.com\/blog\/#organization"},"articleSection":["Software"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.orielstat.com\/blog\/samd-simd-regulatory-requirements\/","url":"https:\/\/www.orielstat.com\/blog\/samd-simd-regulatory-requirements\/","name":"","isPartOf":{"@id":"https:\/\/www.orielstat.com\/blog\/#website"},"datePublished":"2024-01-12T03:23:44+00:00","dateModified":"2024-01-12T19:56:49+00:00","inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.orielstat.com\/blog\/samd-simd-regulatory-requirements\/"]}]},{"@type":"WebSite","@id":"https:\/\/www.orielstat.com\/blog\/#website","url":"https:\/\/www.orielstat.com\/blog\/","name":"Oriel STAT A MATRIX Blog","description":"","publisher":{"@id":"https:\/\/www.orielstat.com\/blog\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.orielstat.com\/blog\/?s={search_term_string}"},"query-input":"required name=search_term_string"}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/www.orielstat.com\/blog\/#organization","name":"Oriel STAT A MATRIX Blog","url":"https:\/\/www.orielstat.com\/blog\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/logo\/image\/","url":"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2024\/01\/OSAM-Eliquent-logo-color.png","contentUrl":"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2024\/01\/OSAM-Eliquent-logo-color.png","width":1458,"height":1042,"caption":"Oriel STAT A MATRIX Blog"},"image":{"@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/person\/a775f07c9602a3521143e80692594553","name":"usr192162","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/1412cb81dc66fbc000fb222b1ea52700?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/1412cb81dc66fbc000fb222b1ea52700?s=96&d=mm&r=g","caption":"usr192162"},"url":"https:\/\/www.orielstat.com\/blog\/author\/usr192162\/"}]}},"_links":{"self":[{"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/posts\/8152"}],"collection":[{"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/comments?post=8152"}],"version-history":[{"count":4,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/posts\/8152\/revisions"}],"predecessor-version":[{"id":8156,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/posts\/8152\/revisions\/8156"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/media\/4799"}],"wp:attachment":[{"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/media?parent=8152"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/categories?post=8152"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/tags?post=8152"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}