{"id":33217,"date":"2024-07-08T12:11:19","date_gmt":"2024-07-08T16:11:19","guid":{"rendered":"https:\/\/avalere.com\/?p=33217"},"modified":"2024-10-02T15:13:20","modified_gmt":"2024-10-02T19:13:20","slug":"the-fdas-final-rule-on-laboratory-developed-tests-ldts","status":"publish","type":"post","link":"https:\/\/advisory.avalerehealth.com\/news\/the-fdas-final-rule-on-laboratory-developed-tests-ldts","title":{"rendered":"The FDA&#8217;s Final Rule on Laboratory-Developed Tests (LDTs)"},"content":{"rendered":"<p>In a watershed moment for the diagnostic test industry, the Food and Drug Administration (FDA) issued a <a href=\"https:\/\/www.federalregister.gov\/documents\/2024\/05\/06\/2024-08935\/medical-devices-laboratory-developed-tests\">rule<\/a> overhauling how <a href=\"https:\/\/advisory.avalerehealth.com\/insights\/a-paradigm-shift-in-ldt-regulation\">Laboratory Developed Tests (LDTs)<\/a> are regulated. The rule aligns LDTs\u2019 regulatory framework with that of medical devices and details the agency\u2019s rationale for removing enforcement discretion from most LDTs. While this rule expands the FDA\u2019s authority, providers and clinical institutions are concerned of the potential negative impact on patient access. As the new regulatory framework is phased in over the next four years, stakeholders\u2014including laboratories, the wider diagnostics industry, patients, healthcare providers, and payers\u2014must consider the wide-ranging implications of the rule.<\/p>\n<p>The article, authored by Practice Director Laura Housman, lists several opportunities that diagnostic manufacturers may need to reconsider.<\/p>\n<p>To read the full article, visit\u00a0<em><a href=\"https:\/\/medtechintelligence.com\/feature_article\/the-fdas-final-lab-developed-test-rule-places-new-burdens-on-manufacturers\/\">MedTech Intelligence<\/a>.<\/em><\/p>\n<p><strong>Learn More<\/strong><\/p>\n<p>Avalere experts in regulatory strategy, evidence, and market access can help you navigate these evolving dynamics for LDTs. If you have questions regarding how this rule will impact your organization and the diagnostics landscape, <a href=\"https:\/\/pages.avalere.com\/Insights.html\">connect with us<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>In a watershed moment for the diagnostic test industry, the Food and Drug Administration (FDA) issued a rule overhauling how Laboratory Developed Tests (LDTs) are regulated. The rule aligns LDTs\u2019 regulatory framework with that of medical devices and details the agency\u2019s rationale for removing enforcement discretion from most LDTs. While this rule expands the FDA\u2019s&hellip;<\/p>\n","protected":false},"author":35,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[995],"tags":[],"content-categories":[891],"class_list":["post-33217","post","type-post","status-publish","format-standard","hentry","category-news","content-categories-fda-regulatory-pathways","entry","no-media"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>The FDA&#039;s Final Rule on Laboratory-Developed Tests (LDTs) | Avalere Health Advisory<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/advisory.avalerehealth.com\/news\/the-fdas-final-rule-on-laboratory-developed-tests-ldts\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The FDA&#039;s Final Rule on Laboratory-Developed Tests (LDTs) | Avalere Health Advisory\" \/>\n<meta property=\"og:description\" content=\"In a watershed moment for the diagnostic test industry, the Food and Drug Administration (FDA) issued a rule overhauling how Laboratory Developed Tests (LDTs) are regulated. The rule aligns LDTs\u2019 regulatory framework with that of medical devices and details the agency\u2019s rationale for removing enforcement discretion from most LDTs. While this rule expands the FDA\u2019s&hellip;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/advisory.avalerehealth.com\/news\/the-fdas-final-rule-on-laboratory-developed-tests-ldts\" \/>\n<meta property=\"og:site_name\" content=\"Avalere Health Advisory\" \/>\n<meta property=\"article:published_time\" content=\"2024-07-08T16:11:19+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-10-02T19:13:20+00:00\" \/>\n<meta name=\"author\" content=\"mgomez@avalere.com\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@avalerehealth\" \/>\n<meta name=\"twitter:site\" content=\"@avalerehealth\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"mgomez@avalere.com\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"The FDA's Final Rule on Laboratory-Developed Tests (LDTs) | Avalere Health Advisory","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/advisory.avalerehealth.com\/news\/the-fdas-final-rule-on-laboratory-developed-tests-ldts","og_locale":"en_US","og_type":"article","og_title":"The FDA's Final Rule on Laboratory-Developed Tests (LDTs) | Avalere Health Advisory","og_description":"In a watershed moment for the diagnostic test industry, the Food and Drug Administration (FDA) issued a rule overhauling how Laboratory Developed Tests (LDTs) are regulated. The rule aligns LDTs\u2019 regulatory framework with that of medical devices and details the agency\u2019s rationale for removing enforcement discretion from most LDTs. While this rule expands the FDA\u2019s&hellip;","og_url":"https:\/\/advisory.avalerehealth.com\/news\/the-fdas-final-rule-on-laboratory-developed-tests-ldts","og_site_name":"Avalere Health Advisory","article_published_time":"2024-07-08T16:11:19+00:00","article_modified_time":"2024-10-02T19:13:20+00:00","author":"mgomez@avalere.com","twitter_card":"summary_large_image","twitter_creator":"@avalerehealth","twitter_site":"@avalerehealth","twitter_misc":{"Written by":"mgomez@avalere.com","Est. reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/advisory.avalerehealth.com\/news\/the-fdas-final-rule-on-laboratory-developed-tests-ldts#article","isPartOf":{"@id":"https:\/\/advisory.avalerehealth.com\/news\/the-fdas-final-rule-on-laboratory-developed-tests-ldts"},"author":{"name":"mgomez@avalere.com","@id":"https:\/\/advisory.avalerehealth.com\/#\/schema\/person\/61d345e49f3e41ed120bded81755741f"},"headline":"The FDA&#8217;s Final 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