{"id":7931,"date":"2025-01-14T16:40:08","date_gmt":"2025-01-14T16:40:08","guid":{"rendered":"https:\/\/els-solutions.com\/cms\/dev\/?p=7931"},"modified":"2025-01-14T17:04:03","modified_gmt":"2025-01-14T17:04:03","slug":"fda-issues-preliminary-guidance-for-medical-devices-with-artificial-intelligence","status":"publish","type":"post","link":"https:\/\/els-solutions.com\/en\/fda-issues-preliminary-guidance-for-medical-devices-with-artificial-intelligence\/","title":{"rendered":"FDA issues preliminary guidance for medical devices with Artificial Intelligence"},"content":{"rendered":"<p>The US Food and Drug Administration (FDA) has issued a <strong><a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-issues-comprehensive-draft-guidance-developers-artificial-intelligence-enabled-medical-devices\">draft guidance<\/a><\/strong> for Developers of Artificial Intelligence-Enabled Medical Devices.<\/p>\n<p>If finalized, this will be the first guidance to provide comprehensive recommendations for AI medical devices, offering their creators an accessible set of considerations that promote the safety and effectiveness of the devices.<\/p>\n<p>This guidance aligns with the <strong>FDA&#8217;s commitment<\/strong> in <strong>promoting safe<\/strong> and <strong>effective innovations<\/strong> in the sector, and it has also<strong><a href=\"https:\/\/els-solutions.com\/en\/fda-proposes-draft-guidance-to-ensure-ai-credibility-in-drug-and-biologic-submissions\/\"> issued preliminary guidance<\/a><\/strong> on the use of AI in the development of drugs and biological products.<\/p>\n<h3>Artificial Intelligence and the medical device market<\/h3>\n<p>In the United States, the number of medical devices with artificial intelligence has <strong><a href=\"https:\/\/www.medtechdive.com\/news\/fda-ai-medical-devices-growth\/728975\/\">increased significantly<\/a><\/strong> over the last decade.<\/p>\n<p>The FDA has already approved more than 1,000 devices based on AI or machine learning, and has also seen a huge increase in <strong>new product submissions<\/strong>.<\/p>\n<p>In academia, <strong><a href=\"https:\/\/www.sciencedirect.com\/science\/article\/pii\/S294976122400124X\">studies<\/a> <\/strong>are being carried out on the importance of analyzing the regulatory frameworks of the main regulatory bodies, focusing on the implementation of international standards and global safety protocols.<\/p>\n<h3><strong><br \/>\nRecommendations for Post-Market Monitoring and Risk Management<br \/>\n<\/strong><\/h3>\n<p>The draft guidance outlines recommendations on:<\/p>\n<ul>\n<li>How and when sponsors should describe monitoring in submissions.<\/li>\n<li>Managing the post-market performance of AI-powered devices.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>The proposed recommendations reflect a<strong> comprehensive approach<\/strong> to <strong>risk management throughout the entire lifecycle of the device.<\/strong><\/p>\n<p>The <strong>FDA encourages sponsors<\/strong> to <strong>engage with the agency early on<\/strong> and use this guidance, once finalized, to inform their activities throughout the device lifecycle, including:<\/p>\n<ul>\n<li>Planning,<\/li>\n<li>Development,<\/li>\n<li>Testing,<\/li>\n<li>and continuous monitoring stages.<\/li>\n<\/ul>\n<h3><strong>Transparency, Trends, and Public Feedback<\/strong><\/h3>\n<p>This draft guidance also includes the FDA\u2019s strategies for addressing transparency and trends throughout the lifecycle of AI-powered devices.<\/p>\n<p>Additionally, until April 7, 2025, the FDA is inviting public comments on this draft guidance, with a particular focus on the following questions:<\/p>\n<ul>\n<li>The adequacy of the guidance concerning the AI lifecycle.<\/li>\n<li>The guidance&#8217;s ability to address concerns related to emerging technologies like generative AI.<\/li>\n<li>The approach to performance monitoring (including the use of monitoring plans as a risk mitigation strategy for AI-powered devices).<\/li>\n<li>The type of information about AI-powered devices that should be provided to users and the best way to deliver it.<\/li>\n<\/ul>\n<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-5 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\">\n<div class=\"fusion-builder-row fusion-row fusion-flex-align-items-center fusion-flex-justify-content-center fusion-flex-content-wrap\">\n<div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-8 fusion_builder_column_1_1 1_1 fusion-flex-column\">\n<div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\">\n<div class=\"fusion-content-tb fusion-content-tb-1\">\n<p>For more information about regulatory issues,\u00a0<strong>ELS can help<\/strong>.<\/p>\n<p>Please\u00a0<a href=\"https:\/\/els-solutions.com\/onde-estamos\/\">contact<\/a> your local ELS consultant or email: info@elssolutions.pt<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>First Guidance to Provide Comprehensive Recommendations for Artificial Intelligence in Medical Devices for Developers<\/p>\n","protected":false},"author":9,"featured_media":7936,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[108,107,105,106,122,61,95],"tags":[111,109,123,62,103,110],"class_list":["post-7931","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-artificial-intelligence","category-drugs","category-fda","category-guidance-draft","category-medical-devices","category-news","category-regulations","tag-artificial-intelligence","tag-fda","tag-medical-devices","tag-news","tag-regulations","tag-united-states"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ 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