{"id":222447,"date":"2026-05-29T10:41:00","date_gmt":"2026-05-29T14:41:00","guid":{"rendered":"https:\/\/testing.news-you-need.com\/index.php\/2026\/05\/29\/study-finds-low-pccp-utilization-among-ai-enabled-devices\/"},"modified":"2026-05-29T11:10:11","modified_gmt":"2026-05-29T15:10:11","slug":"study-finds-low-pccp-utilization-among-ai-enabled-devices","status":"publish","type":"post","link":"https:\/\/testing.news-you-need.com\/index.php\/2026\/05\/29\/study-finds-low-pccp-utilization-among-ai-enabled-devices\/","title":{"rendered":"Study finds low PCCP utilization among AI-enabled devices"},"content":{"rendered":"<p><a href=\"https:\/\/www.raps.org\/resource\/study-finds-low-pccp-utilization-among-ai-enabled-devices.html\">Study finds low PCCP utilization among AI-enabled devices<\/a><\/p>\n<p><a href=\"https:\/\/www.raps.org\/resource\/study-finds-low-pccp-utilization-among-ai-enabled-devices.html\">https:\/\/www.raps.org\/resource\/study-finds-low-pccp-utilization-among-ai-enabled-devices.html<\/a><\/p>\n<p>Publish Date: <a href=\"publish_date]\">2026-05-29 10:41:00<\/a><\/p>\n<p>Source Domain: <a href=\"www.raps.org\">www.raps.org<\/a><\/p>\n<ul>\n<li>Most manufacturers of AI-enabled medical devices are not using predetermined change control plans (PCCPs) to manage changes throughout the device&#8217;s lifecycle, according to a study published in JAMA Health Forum.<\/li>\n<li>From 2023 to 2025, out of 794 AI-enabled medical devices reviewed, only 5.4% (43 devices) had FDA-authorized PCCPs.<\/li>\n<li>The FDA issued final guidance on PCCPs for AI\/ML software products in December 2024, focusing on proactive planning for product updates without new premarket applications.<\/li>\n<li>Only 72% of the authorized PCCPs included all four key elements recommended by the FDA: modification list, modification protocols, notification plan, and impact assessment.<\/li>\n<li>The low adoption of PCCPs suggests a &#8220;missed opportunity&#8221; to improve device performance, as these plans can help mitigate risk and allow for quick implementation of modifications.<\/li>\n<li>Identified barriers to the use of PCCPs remain unidentified despite the process being generally accessible to manufacturers of varying experience levels.<\/li>\n<\/ul>\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Study finds low PCCP utilization among AI-enabled devices https:\/\/www.raps.org\/resource\/study-finds-low-pccp-utilization-among-ai-enabled-devices.html Publish Date: 2026-05-29 10:41:00 Source Domain:&#8230;<\/p>\n","protected":false},"author":1,"featured_media":222448,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"fifu_image_url":"https:\/\/www.raps.org\/static\/1454c1f5-29fc-445b-b61cb6aa52c979ad\/opengraphimage_a162f340e24dc4d08dd7995529c01e82_4a7c7e45a350\/FDAHQ260416.png","fifu_image_alt":"","footnotes":""},"categories":[14],"tags":[],"class_list":["post-222447","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-artificial-intelligence"],"_links":{"self":[{"href":"https:\/\/testing.news-you-need.com\/index.php\/wp-json\/wp\/v2\/posts\/222447"}],"collection":[{"href":"https:\/\/testing.news-you-need.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/testing.news-you-need.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/testing.news-you-need.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/testing.news-you-need.com\/index.php\/wp-json\/wp\/v2\/comments?post=222447"}],"version-history":[{"count":1,"href":"https:\/\/testing.news-you-need.com\/index.php\/wp-json\/wp\/v2\/posts\/222447\/revisions"}],"predecessor-version":[{"id":222449,"href":"https:\/\/testing.news-you-need.com\/index.php\/wp-json\/wp\/v2\/posts\/222447\/revisions\/222449"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/testing.news-you-need.com\/index.php\/wp-json\/wp\/v2\/media\/222448"}],"wp:attachment":[{"href":"https:\/\/testing.news-you-need.com\/index.php\/wp-json\/wp\/v2\/media?parent=222447"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/testing.news-you-need.com\/index.php\/wp-json\/wp\/v2\/categories?post=222447"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/testing.news-you-need.com\/index.php\/wp-json\/wp\/v2\/tags?post=222447"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}