{"id":6891,"date":"2023-11-01T20:18:41","date_gmt":"2023-11-01T20:18:41","guid":{"rendered":"https:\/\/www.orielstat.com\/blog\/?p=6891"},"modified":"2024-01-11T16:40:32","modified_gmt":"2024-01-11T16:40:32","slug":"fda-cdss-approval-process","status":"publish","type":"post","link":"https:\/\/www.orielstat.com\/blog\/fda-cdss-approval-process\/","title":{"rendered":"A Guide to FDA Clinical Decision Support (CDS) Software Approval"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"6891\" class=\"elementor elementor-6891\" 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-1b0c5cde elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"1b0c5cde\" 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-6dd05cd3\" data-id=\"6dd05cd3\" 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-7ca59751 blog-details-page elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"7ca59751\" 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-6ea4084d\" data-id=\"6ea4084d\" 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-3fab5c3f elementor-widget elementor-widget-post-info\" data-id=\"3fab5c3f\" 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\/2023\/11\/01\/\">\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\tNovember 1, 2023\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-5f16c1c2 elementor-widget elementor-widget-heading\" data-id=\"5f16c1c2\" 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\">A Guide to FDA Clinical Decision Support (CDS) Software Approval<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1f7ff590 elementor-widget elementor-widget-image\" data-id=\"1f7ff590\" 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=\"1956\" height=\"1237\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/11\/B-0166-Doctors-looking-at-tablet.png\" class=\"attachment-full size-full wp-image-6894\" alt=\"\" loading=\"lazy\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/11\/B-0166-Doctors-looking-at-tablet.png 1956w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/11\/B-0166-Doctors-looking-at-tablet-300x190.png 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/11\/B-0166-Doctors-looking-at-tablet-1024x648.png 1024w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/11\/B-0166-Doctors-looking-at-tablet-768x486.png 768w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/11\/B-0166-Doctors-looking-at-tablet-1536x971.png 1536w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/11\/B-0166-Doctors-looking-at-tablet-500x316.png 500w\" sizes=\"(max-width: 1956px) 100vw, 1956px\" \/>\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-1005398 elementor-widget elementor-widget-text-editor\" data-id=\"1005398\" 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>Clinical decision support (CDS) software has become a critical element of healthcare delivery. It integrates with other devices and technologies to improve the quality and efficacy of healthcare by offering evidence-based information and suggestions, and alleviating some of the mental burden providers carry.<\/p><p>In 2016, US Congress carved out certain CDS software functionalities that should not be regulated as Software as a Medical Device (SaMD) when it signed the 21st Century Cures Act into law. While this drew a line between device and non-device CDS, that line has blurred as the US FDA attempted to articulate how it will regulate CDS software going forward. Now CDS developers are bogged down in a sea of regulation and guidance, trying to determine how to legally bring their product to market.<\/p><p>In this article, we\u2019ll examine the FDA\u2019s recommendations that determine whether your clinical decision support software qualifies as a medical device. We\u2019ll discuss the criteria implied in the guidance and how to proceed if your software product is regulated as a medical device under the FDA.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6006e54b elementor-widget elementor-widget-heading\" data-id=\"6006e54b\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">CDS background and response from industry<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2ce6da04 elementor-widget elementor-widget-text-editor\" data-id=\"2ce6da04\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>Before we dig into the criteria, let\u2019s take a brief look at how we got here. Here\u2019s a timeline:<\/p><p><strong>2016:<\/strong> US Congress enacted the 21st Century Cures Act. The Cures Act amended the definition of a medical device as defined in the Food, Drug, and Cosmetic Act (FD&amp;C Act). It specified four functions that, when all were met, would exclude software from regulatory oversight.<\/p><p><strong>2017:<\/strong> US FDA released draft guidance that articulated how FDA would interpret these criteria as they relate to clinical decision support software.<\/p><p><strong>2019:<\/strong> Following input from industry, FDA released a revised draft guidance, which incorporated the International Medical Device Regulators Forum\u2019s (IMDRF) Risk Categorization Framework into the FDA\u2019s approach.<\/p><p><strong>2022:<\/strong> FDA issued its final guidance clarifying its approach for determining whether clinical decision support (CDS) software fits the definition of a medical device: <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/clinical-decision-support-software\">Clinical Decision Support Software<\/a>. Recommendations in the guidance are a shift from the 2019 draft guidance and do not include the IMDRF\u2019s risk categorization scheme. FDA also released revisions to two relevant final guidance documents: <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/policy-device-software-functions-and-mobile-medical-applications\">Policy for Device Software Functions and Mobile Medical Applications<\/a> and <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/medical-device-data-systems-medical-image-storage-devices-and-medical-image-communications-devices\">Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices<\/a>.<\/p><p>Product manufacturers, software developers, and even providers have raised concerns about the implications of the final guidance. The consensus from many in the industry is that FDA\u2019s interpretation of the guidance narrows the field of non-device CDS considerably, even more than Congress intended.<\/p><p>Some are concerned the guidance will dampen innovation in the CDS software space due to the regulatory and time burden of moving a product through the FDA clearance process. However, the FDA is concerned that as healthcare providers rely more and more on automation and decision support, the potential for patient harm increases. Software malfunctions, inaccurate or incomplete information, and automation bias are all circumstances that could put a patient at risk. With this guidance, FDA seeks to mitigate these risks.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a1af7ef elementor-widget elementor-widget-heading\" data-id=\"a1af7ef\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Four criteria that excludes CDS software from FDA oversight<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cb40341 elementor-widget elementor-widget-text-editor\" data-id=\"cb40341\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>The guidance addresses four device functionality criteria that a CDS software product must fulfill to classify as a non-device CDS. All four criteria must be met.<\/p><p>Criteria 1 and 2 address allowable data inputs:<\/p><p style=\"padding-left: 40px;\"><strong>1. The software is not intended to acquire, process, or analyze a medical image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system.<\/strong><\/p><p style=\"padding-left: 40px;\"><strong>2. The software is intended for the purpose of displaying, analyzing, or printing medical information about a patient or other medical information (such as peer-reviewed clinical studies and clinical practice guidelines).<\/strong><\/p><p>FDA is taking a narrow interpretation of the first two criteria that will land many software tools in the device category, particularly in its definition of a \u201cpattern\u201d and \u201cmedical information.\u201d There is also some ambiguity between the two criteria.<\/p><p>The guidance implies that any repeated measurement would be considered a pattern. For instance, a tool that acquires readings from a continuous blood glucose meter, would not meet Criterion 1 because the source of the data (IVD) is disallowed and the series of blood glucose levels would establish a pattern. However, Criterion 2 allows \u201cdata\/results from devices (including IVD test(s)), when used in a manner consistent with the FDA-required labeling,\u201d to be generally considered \u201cmedical information about a patient\u201d within the meaning of Criterion 2. This interpretation could include lab test results, such as a blood glucose level, as \u201cmedical information.\u201d<\/p><p>FDA\u2019s overall definition of \u201cmedical information\u201d raises some concerns as to how it can be interpreted and applied in a software development setting: \u201cinformation that normally is, and generally can be, communicated between HCPs in a clinical conversation or between HCPs and patients in the context of a clinical decision, meaning that the relevance of the information to the clinical decision being made is well understood and accepted.\u201d This interplay between the two seems to imply that such data is allowable only within the context of a more comprehensive picture of a patient\u2019s health.<\/p><p>Criteria 3 and 4 address allowable data outputs:<\/p><p style=\"padding-left: 40px;\"><strong>3. The software function is intended for the purpose of supporting or providing recommendations to a healthcare professional about prevention, diagnosis, or treatment of a disease or condition.<\/strong><\/p><p style=\"padding-left: 40px;\"><strong>4. The software function is intended for the purpose of enabling health care professionals to independently review the basis for such recommendations that such software presents so that it is not the intent that such health care professionals rely primarily on any of such recommendations to make a clinical diagnosis or treatment decision regarding an individual patient.<\/strong><\/p><p>While FDA allows for recommendations that are \u201ccondition-, disease-, and\/or patient-specific,\u201d they cannot be time-sensitive or singular to meet this criteria. As you can imagine, these caveats significantly narrow the field of qualifying tools and seems to limit the tools that do qualify to those that deliver <em>lists<\/em> of diagnostic or treatment options.<\/p><p>In its lengthy exploration of device CDS, the guidance cites numerous examples of tools that fail to meet Criteria 3 because their recommendation constitutes a single diagnosis or treatment option or because they are time-sensitive. For example, software that analyzes medical information about a patient to cue an alarm for a provider about a potential life-threatening condition, such as stroke or sepsis, would be considered a device. However, software intended to identify drug-drug interactions and or allergies intended to prevent adverse drug reactions would not be considered a device.<\/p><p>Time-sensitive decision support also plays into the FDA\u2019s rationale behind Criteria 4. To meet Criteria 4, the provider must have access and ability to review the data behind the software\u2019s recommendations, including the underlying algorithm logic or methods, datasets, and validation in \u201cplain language\u201d either via the labeling or the outputs. The intent is for providers to independently assess whether the recommendations are relevant to their patient and they must have time to do so before acting on the recommendation.<\/p><p>Criteria 4 is the most abstract and determining its application will likely be a challenge for many developers. The guidance suggests usability testing as a route to determining whether your product fulfills this criterion.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0f0f011 elementor-widget elementor-widget-heading\" data-id=\"0f0f011\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">What\u2019s next for Clinical Decision Support software regulation from FDA?<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-08bb4a2 elementor-widget elementor-widget-text-editor\" data-id=\"08bb4a2\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>The final guidance is likely to move many software products that were assumed to be non-device CDS under the terms of the 2019 draft guidance into the device category. This means products that were placed on the market or put into development under the conclusion that they would not be marketed as a device will need to reassess their product\u2019s functionality and\/or it\u2019s go-to-market strategy. You may also benefit from engaging with the FDA about how the final guidance impacts your product by seeking their input via the Q-Submission program. We can help you identify your next steps if you think your CDS software\u2019s device classification is in question. We can help you evaluate your product\u2019s functionality against the new guidance and determine your software\u2019s status. We\u2019ll help you <a href=\"https:\/\/www.orielstat.com\/consulting\/FDA-Pre-Submission-Q-Submission-consulting\">prepare for a Pre-Submission meeting<\/a> with the FDA, if needed. If your product is ruled a medical device, we\u2019ll perform a thorough gap analysis and help you <a href=\"https:\/\/www.orielstat.com\/practice\/FDA-510k-submissions-consulting\">prepare your 510(k)<\/a>.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-17b2a83c elementor-widget elementor-widget-heading\" data-id=\"17b2a83c\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Want to learn more?<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3fded163 elementor-widget elementor-widget-text-editor\" data-id=\"3fded163\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>You\u2019ve made it this far so clearly this article was of interest. 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href=\"https:\/\/www.orielstat.com\/blog\/category\/software-cybersecurity\/\">Software and Cybersecurity<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-32\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/supplier-management\/\">Supplier Management<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-67\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/training\/\">Training<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-1\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/medical-device-ra-qa\/\">Uncategorized<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-35\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/validation\/\">Validation<\/a>\n<\/li>\n\t\t\t<\/ul>\n\n\t\t\t<\/section>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>A Guide to FDA Clinical Decision Support (CDS) Software Approval Clinical decision support (CDS) software has become a critical element of healthcare delivery. It integrates with other devices and technologies to improve the quality and efficacy of healthcare by offering evidence-based information and suggestions, and alleviating some of the mental burden providers carry. In 2016, [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":6894,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":[],"categories":[14,63],"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>A Guide to FDA Clinical Decision Support (CDS) Software Approval<\/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\/fda-cdss-approval-process\/\" \/>\r\n<meta property=\"og:locale\" content=\"en_US\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:title\" content=\"A Guide to FDA Clinical Decision Support (CDS) Software Approval\" \/>\r\n<meta property=\"og:description\" content=\"A Guide to FDA Clinical Decision Support (CDS) Software Approval Clinical decision support (CDS) software has become a critical element of healthcare delivery. It integrates with other devices and technologies to improve the quality and efficacy of healthcare by offering evidence-based information and suggestions, and alleviating some of the mental burden providers carry. In 2016, [&hellip;]\" \/>\r\n<meta property=\"og:url\" content=\"https:\/\/www.orielstat.com\/blog\/fda-cdss-approval-process\/\" \/>\r\n<meta property=\"og:site_name\" content=\"Oriel STAT A MATRIX - ELIQUENT Life Sciences Blog\" \/>\r\n<meta property=\"article:published_time\" content=\"2023-11-01T20:18:41+00:00\" \/>\r\n<meta property=\"article:modified_time\" content=\"2024-01-11T16:40:32+00:00\" \/>\r\n<meta property=\"og:image\" content=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/11\/B-0166-Doctors-looking-at-tablet-1024x648.png\" \/>\r\n\t<meta property=\"og:image:width\" content=\"1024\" \/>\r\n\t<meta property=\"og:image:height\" content=\"648\" \/>\r\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\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=\"8 minutes\" \/>\r\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"A Guide to FDA Clinical Decision Support (CDS) Software Approval","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\/fda-cdss-approval-process\/","og_locale":"en_US","og_type":"article","og_title":"A Guide to FDA Clinical Decision Support (CDS) Software Approval","og_description":"A Guide to FDA Clinical Decision Support (CDS) Software Approval Clinical decision support (CDS) software has become a critical element of healthcare delivery. It integrates with other devices and technologies to improve the quality and efficacy of healthcare by offering evidence-based information and suggestions, and alleviating some of the mental burden providers carry. In 2016, [&hellip;]","og_url":"https:\/\/www.orielstat.com\/blog\/fda-cdss-approval-process\/","og_site_name":"Oriel STAT A MATRIX - ELIQUENT Life Sciences Blog","article_published_time":"2023-11-01T20:18:41+00:00","article_modified_time":"2024-01-11T16:40:32+00:00","og_image":[{"width":1024,"height":648,"url":"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/11\/B-0166-Doctors-looking-at-tablet-1024x648.png","type":"image\/png"}],"author":"usr192162","twitter_card":"summary_large_image","twitter_misc":{"Written by":"usr192162","Est. reading time":"8 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.orielstat.com\/blog\/fda-cdss-approval-process\/#article","isPartOf":{"@id":"https:\/\/www.orielstat.com\/blog\/fda-cdss-approval-process\/"},"author":{"name":"usr192162","@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/person\/a775f07c9602a3521143e80692594553"},"headline":"A Guide to FDA Clinical Decision Support (CDS) Software Approval","datePublished":"2023-11-01T20:18:41+00:00","dateModified":"2024-01-11T16:40:32+00:00","mainEntityOfPage":{"@id":"https:\/\/www.orielstat.com\/blog\/fda-cdss-approval-process\/"},"wordCount":1446,"publisher":{"@id":"https:\/\/www.orielstat.com\/blog\/#organization"},"articleSection":["FDA 21 CFR Part 820","Software and Cybersecurity"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.orielstat.com\/blog\/fda-cdss-approval-process\/","url":"https:\/\/www.orielstat.com\/blog\/fda-cdss-approval-process\/","name":"A Guide to FDA Clinical Decision Support (CDS) Software Approval","isPartOf":{"@id":"https:\/\/www.orielstat.com\/blog\/#website"},"datePublished":"2023-11-01T20:18:41+00:00","dateModified":"2024-01-11T16:40:32+00:00","inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.orielstat.com\/blog\/fda-cdss-approval-process\/"]}]},{"@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\/6891"}],"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=6891"}],"version-history":[{"count":17,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/posts\/6891\/revisions"}],"predecessor-version":[{"id":7966,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/posts\/6891\/revisions\/7966"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/media\/6894"}],"wp:attachment":[{"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/media?parent=6891"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/categories?post=6891"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/tags?post=6891"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}