{"id":81536,"date":"2025-08-25T03:00:59","date_gmt":"2025-08-25T10:00:59","guid":{"rendered":"https:\/\/www.jamasoftware.com\/?post_type=resource-page&#038;p=81536"},"modified":"2025-08-25T15:16:11","modified_gmt":"2025-08-25T22:16:11","slug":"be-prepared-by-managing-ruo-and-ldt-product-requirements-with-jama-connect-for-medical-devices","status":"publish","type":"resource-page","link":"https:\/\/www.jamasoftware.com\/resource\/datasheet\/managing-ruo-and-ldt-product-requirements-with-jama-connect-for-medical-devices\/","title":{"rendered":"Managing RUO and LDT Product Requirements with Jama Connect for Medical Devices"},"content":{"rendered":"<div id='av_section_1'  class='avia-section av-5q8apgt-36372e22ecc21a601d39672b501b29eb main_color avia-section-default avia-no-border-styling  avia-builder-el-0  el_before_av_section  avia-builder-el-first  avia-bg-style-scroll container_wrap sidebar_right'  ><div class='container av-section-cont-open' ><main  class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-81536'><div class='entry-content-wrapper clearfix'>\n<div  class='flex_column av-5gd7sa5-8506abe4f00a744469d0808ccc6af57b av_one_full  avia-builder-el-1  el_before_av_one_third  avia-builder-el-first  first flex_column_div  '     ><p><br \/>\n<\/p><\/div><div class='flex_column_table av-4zwgmel-46a6da950619547e0b2d2c6a4b939113 sc-av_one_third av-equal-height-column-flextable'><div  class='flex_column av-4zwgmel-46a6da950619547e0b2d2c6a4b939113 av_one_third  avia-builder-el-4  el_after_av_one_full  el_before_av_two_third  first flex_column_table_cell av-equal-height-column av-align-middle  column-top-margin'     ><\/div><div class='av-flex-placeholder'><\/div><div  class='flex_column av-4io0swd-d6db1ade87ef28d835af17a1d7f1e6e8 av_two_third  avia-builder-el-6  el_after_av_one_third  avia-builder-el-last  flex_column_table_cell av-equal-height-column av-align-middle  column-top-margin'     ><p><section  class='av_textblock_section av-ljz182u1-c98d665e2ff244c5a9bb4fe18fb256e3 '  ><div class='avia_textblock' ><p>Research Use Only (RUO) products are non-invasive and non-diagnostic which only require \u201cFor Research Only\u201d labeling under FDA guidelines. The FDA defines Laboratory Developed Tests (LDTs) as in vitro diagnostic products (IVDs) designed, manufactured, and used within a single laboratory. Although the FDA does not regulate RUO and LDT products today, many companies have future plans to expand indications turning their RUO or LDT products into regulated medical devices.<\/p>\n<p>Jama Connect for Medical Devices provides an easy-to-use, out-of-the-box, flexible framework that enables development teams to begin with this framework and seamlessly transition to the regulatory-compliant medical device framework if necessary.<\/p>\n<p>Read this datasheet to learn more about key benefits:<\/p>\n<ul>\n<li>Define RUO requirements as good business practice<\/li>\n<li>Prepare for future iterations<\/li>\n<li>Reduce wasted time and risk with automated tracking and collaboration<\/li>\n<\/ul>\n<\/div><\/section><br \/>\n<div  class='avia-button-wrap av-ljz195h3-c9748722d50e5107442a355282d323d0-wrap avia-button-left  avia-builder-el-8  el_after_av_textblock  avia-builder-el-last '><a href='https:\/\/www.jamasoftware.com\/resource\/datasheet\/managing-ruo-and-ldt-product-requirements-with-jama-connect-for-medical-devices-thank-you'  class='avia-button av-ljz195h3-c9748722d50e5107442a355282d323d0 av-link-btn avia-icon_select-no avia-size-medium avia-position-left avia-color-green'   aria-label=\"DOWNLOAD DATASHEET\"><span class='avia_iconbox_title' >DOWNLOAD DATASHEET<\/span><\/a><\/div><\/p><\/div><\/div><!--close column table wrapper. Autoclose: 1 --><\/div><\/div><\/main><!-- close content main element --><\/div><\/div><div id='av_section_2'  class='avia-section av-ljz1a1si-4a99790c1c2c8edbe75423e7f5362255 main_color avia-section-default avia-no-border-styling  avia-builder-el-9  el_after_av_section  avia-builder-el-last  related-content avia-bg-style-scroll container_wrap sidebar_right'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-81536'><div class='entry-content-wrapper clearfix'>\n<div  class='flex_column av-3xmgurx-c1e084f5636b5016f1e13fb0fe4ba495 av_one_full  avia-builder-el-10  el_before_av_hr  avia-builder-el-first  first flex_column_div  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-ljz1arsj-b6f985228b951385efe523b4e2def331\">\n#top .av-special-heading.av-ljz1arsj-b6f985228b951385efe523b4e2def331{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-ljz1arsj-b6f985228b951385efe523b4e2def331 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-ljz1arsj-b6f985228b951385efe523b4e2def331 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-ljz1arsj-b6f985228b951385efe523b4e2def331 av-special-heading-h3 blockquote modern-quote  avia-builder-el-11  avia-builder-el-no-sibling '><h3 class='av-special-heading-tag '  >You might also enjoy this related content:<\/h3><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lker9lca-38696cfb3e81154d49ac778cf54ebee0\">\n#top .hr.hr-invisible.av-lker9lca-38696cfb3e81154d49ac778cf54ebee0{\nheight:30px;\n}\n<\/style>\n<div  class='hr av-lker9lca-38696cfb3e81154d49ac778cf54ebee0 hr-invisible  avia-builder-el-12  el_after_av_one_full  el_before_av_codeblock '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='after_section_2'  class='main_color av_default_container_wrap container_wrap sidebar_right'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-81536'><div class='entry-content-wrapper clearfix'><\/p>\n<input class=\"fooboxshare_post_id\" type=\"hidden\" value=\"81536\"\/>","protected":false},"excerpt":{"rendered":"","protected":false},"author":125,"featured_media":81539,"template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"resource_type":[892],"resource_industry":[901],"primary_topic":[913,929],"primary_challenge":[943],"competitors":[],"partners":[],"secondary_topic":[],"secondary_challenge":[],"class_list":["post-81536","resource-page","type-resource-page","status-publish","has-post-thumbnail","hentry","resource_type-datasheet","resource_industry-medical-devices-life-science","primary_topic-compliance-regulation","primary_topic-process-improvement","primary_challenge-industry-competitive-challenges"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.0 (Yoast SEO v27.2) - 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