{"id":27695,"date":"2026-01-29T10:18:56","date_gmt":"2026-01-29T10:18:56","guid":{"rendered":"https:\/\/quickbirdmedical.com\/?post_type=news&#038;p=27695"},"modified":"2026-09-03T07:47:29","modified_gmt":"2026-09-03T07:47:29","slug":"fda-update-general-wellness-clinical-decision-support-software","status":"publish","type":"news","link":"https:\/\/quickbirdmedical.com\/en\/news\/fda-update-general-wellness-clinical-decision-support-software\/","title":{"rendered":"FDA: Revised Guidance on General Wellness and Clinical Decision Support Software"},"content":{"rendered":"<p>At the start of the year, the FDA updated <strong>two guidance documents<\/strong>. Here is a brief overview of the key changes.<\/p>\n<p><strong>a) General Wellness: Policy for Low Risk Devices<\/strong><\/p>\n<p>In contrast to medical devices, the guidance defines general wellness products as products that meet the following two criteria:<\/p>\n<ul>\n<li>They are intended <strong>exclusively for general wellness purposes<\/strong>, and<\/li>\n<\/ul>\n<ul>\n<li>They present a <strong>low risk to the safety of users<\/strong> and other persons.<\/li>\n<\/ul>\n<p>According to the FDA, this can also cover products that use <strong>non-invasive sensors<\/strong> (optical sensors, for example) to <strong>estimate, derive or output physiological parameters<\/strong> (such as blood pressure, oxygen saturation, blood glucose or heart rate variability).<\/p>\n<p>This clarifies the FDA&#8217;s position on this product category. As recently as last autumn, the manufacturer of the WHOOP fitness band received a <a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/whoop-inc-709755-07142025\">warning letter from the FDA<\/a> over its feature for <strong>estimating blood pressure as a systolic and diastolic value<\/strong>. This, the FDA argued, qualified the band as a medical device, because blood pressure cannot be used without reference to a disease. The FDA is now making clear that <strong>non-invasive blood pressure readings<\/strong> can also be <strong>permissible without medical device status<\/strong>.<\/p>\n<p>You can read the guidance here: <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/general-wellness-policy-low-risk-devices\">General Wellness: Policy for Low Risk Devices | FDA<\/a><\/p>\n<p><strong>b) Clinical Decision Support Software guidance<\/strong><\/p>\n<p><strong>The FDA does not classify clinical decision support software as a medical device<\/strong> if all of these conditions are met:<\/p>\n<ul>\n<li>The software is not intended to acquire, process or analyse medical images, signals\/patterns from in vitro diagnostic devices or signal acquisition systems.<\/li>\n<li>It is intended to display, analyse or print medical information about a patient or other medical information,<\/li>\n<li>It supports healthcare professionals or gives them recommendations on prevention, diagnosis or treatment.<\/li>\n<li>It enables healthcare professionals to independently review the basis for the recommendations given by the software. It is not intended that they rely primarily on the software&#8217;s recommendations to make a clinical diagnosis or treatment decision.<\/li>\n<\/ul>\n<p>The <strong>guidance on clinical decision support software<\/strong> has now been revised in the following respects, among others:<\/p>\n<p><strong>Recommendations without a second option<\/strong>: under &#8220;enforcement discretion&#8221;, the FDA now permits CDS tools that give only <strong>a single recommendation<\/strong>, provided the other criteria listed above are met. Previously, a list of options always had to be displayed for the software not to count as a medical device, which was often impractical and not clinically useful.<\/p>\n<p><strong>Support for clinical review<\/strong>: software that displays, analyses or prints medical information <strong>often remains exempt from FDA regulation<\/strong>, as long as healthcare professionals can review the recommendations independently. This relieves manufacturers of unnecessary regulation.<\/p>\n<p><strong>Focus on usability and transparency:<\/strong> the FDA now emphasises that clinically <strong>relevant information<\/strong> should be presented <strong>clearly and legibly<\/strong>. At the same time, it stresses that the recommendations issued by the software must be based on <strong>recognised, evidence-based sources<\/strong>.<\/p>\n<p class=\"last-child\">You can find the published guidance here: <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/clinical-decision-support-software\/\" target=\"_blank\" rel=\"noopener\">Clinical Decision Support Software | FDA<\/a><\/p>\n","protected":false},"featured_media":0,"template":"","categories":[],"tags":[],"display":[54],"class_list":["post-27695","news","type-news","status-publish","hentry","display-display-on-news-page"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>FDA: Revised Guidance on Clinical Decision Support Software<\/title>\n<meta name=\"description\" content=\"FDA updates its guidance on general wellness products and clinical decision support software.\" \/>\n<meta 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