{"id":7880,"date":"2026-06-10T10:07:16","date_gmt":"2026-06-10T04:37:16","guid":{"rendered":"https:\/\/operonstrategist.com\/?p=7880"},"modified":"2026-06-10T10:07:16","modified_gmt":"2026-06-10T04:37:16","slug":"new-developments-in-fda-regulation-of-ai","status":"publish","type":"post","link":"https:\/\/operonstrategist.com\/gb-en\/new-developments-in-fda-regulation-of-ai\/","title":{"rendered":"Artificial Intelligence in Medical Devices: FDA Regulation and Guidelines"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"7880\" class=\"elementor elementor-7880\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-781d31bb e-flex e-con-boxed e-con e-parent\" data-id=\"781d31bb\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5fa0ce1b elementor-widget elementor-widget-heading\" data-id=\"5fa0ce1b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Artificial Intelligence in Medical Devices: FDA Regulation and Guidelines<\/h1>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-3fc5ed48 e-flex e-con-boxed e-con e-parent\" data-id=\"3fc5ed48\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-fc75697 e-con-full e-flex e-con e-child\" data-id=\"fc75697\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2e5d3b66 elementor-widget elementor-widget-text-editor\" data-id=\"2e5d3b66\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>\u00a0<\/p><p><span style=\"font-weight: 400;\">New Developments in FDA Regulation of AI have been announced on Tuesday that it is developing a framework for regulating artificial intelligence products used in medicine that continually adapt based on new data. Artificial intelligence (AI) can be broadly defined as a device or product that can imitate intelligent behavior.<\/span><\/p><p><span style=\"font-weight: 400;\">In the health care space, this could include a machine learning algorithm that evolves and improves as new data inputs are entered. This type of adaptive algorithm can provide physicians with diagnostic information for numerous medical conditions.<\/span><\/p><p><span style=\"font-weight: 400;\">While AI-based medical products hold tremendous potential, the question of their regulation has challenged the U.S. Food and Drug Administration (\u201cFDA\u201d).FDA regulates software-based devices. FDA reviews medical devices through <\/span><a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/fda-510k\/\"><span style=\"font-weight: 400;\">FDA 510(k)clearance<\/span><\/a><span style=\"font-weight: 400;\"> process or premarket approval. A 510(k) is premarket submission which says that the device is safe &amp; effective.\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-40c81736 e-con-full e-flex e-con e-child\" data-id=\"40c81736\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-16f6e140 e-con-full e-flex e-con e-child\" data-id=\"16f6e140\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-37bd9ca0 elementor-widget elementor-widget-heading\" data-id=\"37bd9ca0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">talk to our experts\n<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1423dd7 elementor-widget elementor-widget-wpforms\" data-id=\"1423dd7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"wpforms.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"wpforms-container wpforms-container-full wpforms-render-modern\" id=\"wpforms-6203\"><form id=\"wpforms-form-6203\" class=\"wpforms-validate wpforms-form wpforms-ajax-form\" data-formid=\"6203\" method=\"post\" enctype=\"multipart\/form-data\" action=\"\/gb-en\/wp-json\/wp\/v2\/posts\/7880\" data-token=\"24a33a86f378ed1e881eb77b5877b2eb\" data-token-time=\"1781092904\"><noscript class=\"wpforms-error-noscript\">Please enable JavaScript in your browser to complete this form.<\/noscript><div id=\"wpforms-error-noscript\" style=\"display: none;\">Please enable JavaScript in your browser to complete this form.<\/div><div class=\"wpforms-field-container\"><div id=\"wpforms-6203-field_1-container\" class=\"wpforms-field wpforms-field-name\" data-field-id=\"1\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_1\" aria-hidden=\"false\">Name <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"text\" id=\"wpforms-6203-field_1\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][1]\" placeholder=\"Name*\" aria-errormessage=\"wpforms-6203-field_1-error\" required><\/div>\t\t<div id=\"wpforms-6203-field_5-container\"\n\t\t\tclass=\"wpforms-field wpforms-field-text\"\n\t\t\tdata-field-type=\"text\"\n\t\t\tdata-field-id=\"5\"\n\t\t\t>\n\t\t\t<label class=\"wpforms-field-label\" for=\"wpforms-6203-field_5\" >Text Phone Paragraph<\/label>\n\t\t\t<input type=\"text\" id=\"wpforms-6203-field_5\" class=\"wpforms-field-medium\" name=\"wpforms[fields][5]\" >\n\t\t<\/div>\n\t\t<div id=\"wpforms-6203-field_2-container\" class=\"wpforms-field wpforms-field-email\" data-field-id=\"2\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_2\" aria-hidden=\"false\">Email <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"email\" id=\"wpforms-6203-field_2\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][2]\" placeholder=\"Email*\" spellcheck=\"false\" aria-errormessage=\"wpforms-6203-field_2-error\" required><\/div><div id=\"wpforms-6203-field_3-container\" class=\"wpforms-field wpforms-field-phone\" data-field-id=\"3\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_3\" aria-hidden=\"false\">Phone <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"tel\" id=\"wpforms-6203-field_3\" class=\"wpforms-field-large wpforms-field-required wpforms-smart-phone-field\" data-rule-smart-phone-field=\"true\" name=\"wpforms[fields][3]\" placeholder=\"Phone*\" aria-label=\"Phone\" aria-errormessage=\"wpforms-6203-field_3-error\" required><\/div><div id=\"wpforms-6203-field_4-container\" class=\"wpforms-field wpforms-field-textarea\" data-field-id=\"4\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_4\" aria-hidden=\"false\">Paragraph Text <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><textarea id=\"wpforms-6203-field_4\" class=\"wpforms-field-medium wpforms-field-required\" name=\"wpforms[fields][4]\" placeholder=\"Message\" aria-errormessage=\"wpforms-6203-field_4-error\" required><\/textarea><\/div><script>\n\t\t\t\t( function() {\n\t\t\t\t\tconst style = document.createElement( 'style' );\n\t\t\t\t\tstyle.appendChild( document.createTextNode( '#wpforms-6203-field_5-container { position: absolute !important; overflow: hidden !important; display: inline !important; height: 1px !important; width: 1px !important; z-index: -1000 !important; padding: 0 !important; } #wpforms-6203-field_5-container input { visibility: hidden; } #wpforms-conversational-form-page #wpforms-6203-field_5-container label { counter-increment: none; }' ) );\n\t\t\t\t\tdocument.head.appendChild( style );\n\t\t\t\t\tdocument.currentScript?.remove();\n\t\t\t\t} )();\n\t\t\t<\/script><\/div><!-- .wpforms-field-container --><div class=\"wpforms-recaptcha-container wpforms-is-recaptcha wpforms-is-recaptcha-type-v3\" ><input type=\"hidden\" name=\"wpforms[recaptcha]\" value=\"\"><\/div><div class=\"wpforms-submit-container\" ><input type=\"hidden\" name=\"wpforms[id]\" value=\"6203\"><input type=\"hidden\" name=\"page_title\" value=\"\"><input type=\"hidden\" name=\"page_url\" value=\"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/posts\/7880\"><input type=\"hidden\" name=\"url_referer\" value=\"\"><button type=\"submit\" name=\"wpforms[submit]\" id=\"wpforms-submit-6203\" class=\"wpforms-submit\" data-alt-text=\"Sending...\" data-submit-text=\"Submit\" aria-live=\"assertive\" value=\"wpforms-submit\">Submit<\/button><img decoding=\"async\" src=\"https:\/\/operonstrategist.com\/wp-content\/plugins\/wpforms\/assets\/images\/submit-spin.svg\" class=\"wpforms-submit-spinner\" style=\"display: none;\" width=\"26\" height=\"26\" alt=\"Loading\"><\/div><\/form><\/div>  <!-- .wpforms-container -->\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-7671a2c2 e-flex e-con-boxed e-con e-parent\" data-id=\"7671a2c2\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-32a6f440 elementor-widget elementor-widget-text-editor\" data-id=\"32a6f440\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">At issue are the medical device provisions of the Federal Food, Drug, and Cosmetic Act (\u201dFDCA\u201d), which were initially crafted to address medical devices existing in the mid-1970s when the Medical Device Amendments were enacted. These types of products were mostly hardware based, and iterative technology design changes were relatively infrequent.<\/span><\/p><p><span style=\"font-weight: 400;\">Recently New Developments in FDA Regulation of AI has been taken to address industry concerns about regulation of the digital sector. FDA created a Digital Health Program tasked with developing and implementing a new regulatory model for digital health technology. Over the last five years, the program has issued several enforcement discretion guidance documents.<\/span><\/p><p><span style=\"font-weight: 400;\">In light of that general agreement, what progress are we making toward that goal? This article focuses on some of FDA\u2019s initiatives over the last year and specifically examines the agency\u2019s efforts to define the scope of its New Developments in FDA Regulation of AI, the process and substance of FDA premarket reviews, and finally a few special issues associated with the New Developments in FDA Regulation of AI.<\/span><\/p><p><span style=\"font-weight: 400;\">The New Developments in FDA Regulation of AI guideline presumes that software so developed may not conform to the existing certification process, such that adaptations and extensions to the certification process are needed. So, how does the FDA propose to extend the regulatory process?<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c9e7e6f elementor-widget elementor-widget-heading\" data-id=\"c9e7e6f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">First let\u2019s look at the categories of modifications the FDA is examining. As defined in the guidelines, these are grouped under:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f01508f elementor-widget elementor-widget-text-editor\" data-id=\"f01508f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Performance \u2013 improvements related to analytical and clinical performance, with no change to intended use or input type<\/span><\/li><\/ul><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Inputs \u2013 changes in inputs with no change to intended use, and<\/span><\/li><\/ul><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Intended Use \u2013 a change in the significance of the information provided by the SaMD<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">By including guidelines for the development and release environment and processes, the process seeks to ensure that subsequent releases conform to the original certifications, or that the certifications are revised appropriately, or that an additional review and certification process is triggered prior to release.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fbe1aa1 elementor-widget elementor-widget-heading\" data-id=\"fbe1aa1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">So, how is the \u201corganization\u2019s excellence\u201d reviewed and qualified? The FDA outlines a two-fold approach that seeks to:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-35f1a03 elementor-widget elementor-widget-text-editor\" data-id=\"35f1a03\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<ol><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Assure the usage of Quality Systems and Good Machine Learning Practices (GMLP) by the organization, and<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Assure the usage of SaMD Pre-Specifications (SPS) describing the modifications and Algorithm Change Protocol (ACP) processes to achieve the changes and control the risks.<\/span><\/li><\/ol><p><span style=\"font-weight: 400;\">These approaches work together to determine the level of FDA review required for new modifications. As an example, a change that solely increases performance, is consistent with the SPS, utilizes existing ACP, and does not change intended use or inputs could be made without additional FDA review.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-edacf28 elementor-widget elementor-widget-heading\" data-id=\"edacf28\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">New Developments in FDA Regulation of AI\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f1ccfc9 elementor-widget elementor-widget-text-editor\" data-id=\"f1ccfc9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">AI is different from other medical devices, due in part to the fact that AI learns on the job. The fact that such learning changes performance over time and the fact that the company might make frequent updates both suggest the need for a new regulatory approach.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-47effc0 elementor-widget elementor-widget-heading\" data-id=\"47effc0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">1. Scope Of FDA Regulation Of Medical AI<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fcf75a5 elementor-widget elementor-widget-text-editor\" data-id=\"fcf75a5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">FDA has been working to clarify what software is regulated and what is not. The most recent phase of those efforts began in December 2016 when Congress passed the 21st Century Cures Act (Cures Act), section 3060(a), which modified the definition of a medical device in the Food, Drug &amp; Cosmetic Act.<\/span><\/p><p><span style=\"font-weight: 400;\">The 2016 amendments laid out several categories of software that Congress excluded from FDA regulation. A year later, in 2017, FDA started to implement that legislation by publishing a few draft guidance\u2019s, including one on Clinical and Patient Decision Support Software.<\/span><\/p><p><span style=\"font-weight: 400;\">Much has been written on that topic over the last several years, so this article will only focus on developments in implementing this section since last fall.<\/span><\/p><p><strong>a. Software that Functions as an Accessory to a Medical Device<\/strong><\/p><p><span style=\"font-weight: 400;\">Software remains regulated under the Cures Act if it is \u201cintended 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.\u201d That language is difficult to understand, but at a high level Congress was trying to reserve within FDA\u2019s regulatory scope software that, for example, analyzed radiological images or read EKG signals. In September 2019.<\/span><\/p><p><strong>b. Software as a Medical Device (SaMD)<\/strong><\/p><p><span style=\"font-weight: 400;\">FDA potentially regulates clinical decision support (CDS) software that analyzes medical information to support or provide a recommendation to a healthcare professional about prevention, diagnosis, or treatment of a disease or condition.\u201d potentially\u201d because such software is excluded from FDA regulation if the software enables the professional \u201cto independently review the basis for the recommendations that such software presents so that it is not the intent that the [professional] rely primarily on any of such recommendations to make a clinical diagnosis or treatment decision regarding an individual patient.<\/span><\/p><p><strong>c. Unregulated Software, including Enforcement Discretion<\/strong><\/p><p><span style=\"font-weight: 400;\">This topic gets confusing because there is certain software that FDA cannot by statute regulate, and then there is certain software that FDA says it has the right to regulate but simply chooses not to. That stuff makes my head hurt, so I\u2019m going to lump it all together here.<\/span><\/p><p><span style=\"font-weight: 400;\">New Developments in FDA Regulation of AI updated a whole slew of guidance documents defining what\u2019s unregulated in September of 2019, at the same time the agency proposed the new CDS guidance. Old guidance that FDA updated in September includes:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Policy for Device Software Functions and Mobile Medical Applications<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">General Wellness: Policy for Low Risk Devices<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Off-The-Shelf Software Use in Medical Devices<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">The guidance explains both software categories no longer regulated under the Cures Act as well as software categories where FDA is willing to exercise enforcement discretion.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e7d1de7 elementor-widget elementor-widget-heading\" data-id=\"e7d1de7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">2. Process For Reviewing AI Premarket Submissions\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-18bbc05 elementor-widget elementor-widget-text-editor\" data-id=\"18bbc05\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><strong> Current Process: De Novo<\/strong><\/p><p><span style=\"font-weight: 400;\">Presently, there is a dearth of predicate devices for many AI applications outside of radiology. As a consequence, outside of radiology, many of the new AI applications are coming to market via the de novo review process.<\/span><\/p><p><span style=\"font-weight: 400;\">Unfortunately, that process is long and largely unpredictable. In practice it is more like a premarket approval application, in the sense that FDA has a freer hand to define what the agency wants to see than it has in the 510(k) process in which the agency is limited to those issues related to substantial equivalence. The de novo process requires an assurance of safety and effectiveness typically accomplished through a clinical trial. On top of that, because it\u2019s a reclassification process, the applicant has to demonstrate regulate-ability, which means that:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The safety and effectiveness profile has to be proven to be low enough that FDA is comfortable with reclassifying the product into class I or II, and<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">If class II, the agency knows how to develop special controls to ensure safety and effectiveness of the product category.<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">While there are exceptions like Apple, which managed to breeze through the de novo process in short order, the vast majority of de novo applications are proceeding through a long and torturous route. While the long-term trend shows the number of de novo submissions is growing,<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-57bfbcd elementor-widget elementor-widget-heading\" data-id=\"57bfbcd\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">3. Substantive Requirements AI will Have To Meet Prior To Marketing<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d0e9a30 elementor-widget elementor-widget-text-editor\" data-id=\"d0e9a30\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<h2><span style=\"font-weight: 400;\">a. Preclinical and Clinical Testing<\/span><\/h2><p><span style=\"font-weight: 400;\">For those who want to understand what FDA would require in the form of preclinical and clinical testing for new uses of AI outside of radiology, FDA consistently recommends that developers follow the two primary radiology guidances, including one updated in January 2020:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data \u2013 Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions, January 2020<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data \u2013 Premarket Notification [510(k)] Submissions, July 2012<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">The 510(k) guidance is less useful simply because there are fewer 510(k) opportunities available outside radiology due to the lack of predicate devices. But it nonetheless has good guidance on how to address the intended use issues associated with machine learning.<\/span><\/p><p><span style=\"font-weight: 400;\">On the whole, the FDA seems very enthusiastic about the possibilities for AI to improve healthcare. That\u2019s gratifying to see. While progress in the development of a new regulatory approach is slow, that\u2019s also not all bad. It would be worse in many ways for the FDA to act precipitously. These are complicated issues, and it will take time to develop an appropriate approach, in part because it will take time for FDA to acquire enough expertise. And most likely, whatever new approach we come up with will require new statutory authority. That said, it is incumbent on all of us to work as quickly as we can to bring these exciting new developments to waiting patients. The possible improvements to patient care are enormous. Regulatory changes are for the safety of devices, we are a team of <\/span><a href=\"https:\/\/operonstrategist.com\/\"><span style=\"font-weight: 400;\">medical device consultant<\/span><\/a><span style=\"font-weight: 400;\"> who always provide regulatory services and turkey project solutions to manufacturers.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>New Developments in FDA Regulation of AI have been announced on Tuesday that it is developing a framework for regulating artificial intelligence products used in medicine that continually adapt based on new data. Artificial intelligence (AI) can be broadly defined as a device or product that can imitate intelligent behavior. In the health care space, [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":11736,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[22],"tags":[],"class_list":["post-7880","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-us-fda"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/posts\/7880","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/comments?post=7880"}],"version-history":[{"count":1,"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/posts\/7880\/revisions"}],"predecessor-version":[{"id":11737,"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/posts\/7880\/revisions\/11737"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/media\/11736"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/media?parent=7880"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/categories?post=7880"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/tags?post=7880"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}