{"id":443,"date":"2024-05-20T09:47:22","date_gmt":"2024-05-20T13:47:22","guid":{"rendered":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/?p=443"},"modified":"2024-05-20T09:47:22","modified_gmt":"2024-05-20T13:47:22","slug":"fdas-new-rule-regulates-lab-developed-tests-under-fdc-act","status":"publish","type":"post","link":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2024\/05\/20\/fdas-new-rule-regulates-lab-developed-tests-under-fdc-act\/","title":{"rendered":"FDA&#8217;s New Rule Regulates Lab-Developed Tests Under FD&amp;C Act"},"content":{"rendered":"<p>On April 29, 2024, the U.S. Food and Drug Administration (FDA)\u00a0<a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-takes-action-aimed-helping-ensure-safety-and-effectiveness-laboratory-developed-tests\" target=\"_blank\" rel=\"noopener\">announced<\/a>\u00a0a\u00a0<a href=\"https:\/\/www.federalregister.gov\/documents\/2024\/05\/06\/2024-08935\/medical-devices-laboratory-developed-tests\" target=\"_blank\" rel=\"noopener\">final rule<\/a>\u00a0that amends existing regulations to make explicit that in vitro diagnostic products and tests (IVDs), including laboratory developed tests (LDTs), are devices regulated under the Federal Food, Drug and Cosmetic Act (FD&amp;C Act).<\/p>\n<p>LDTs have increased in volume, complexity and importance in critical healthcare decision-making since 1976 when the Medical Device Amendments (MDA) were passed and FDA began exercising enforcement discretion. Accordingly, FDA has advised that increased oversight is needed for LDTs. However, some specific categories of LDTs will be covered under new targeted enforcement discretion policies.<\/p>\n<p>Read the full\u00a0<em>Alert\u00a0<\/em>on the <a href=\"https:\/\/www.duanemorris.com\/alerts\/fda_finalizes_new_rule_lab_developed_tests_0524.html\">Duane Morris LLP website<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>On April 29, 2024, the U.S. Food and Drug Administration (FDA)\u00a0announced\u00a0a\u00a0final rule\u00a0that amends existing regulations to make explicit that in vitro diagnostic products and tests (IVDs), including laboratory developed tests (LDTs), are devices regulated under the Federal Food, Drug and Cosmetic Act (FD&amp;C Act). LDTs have increased in volume, complexity and importance in critical healthcare &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2024\/05\/20\/fdas-new-rule-regulates-lab-developed-tests-under-fdc-act\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;FDA&#8217;s New Rule Regulates Lab-Developed Tests Under FD&amp;C Act&#8221;<\/span><\/a><\/p>\n","protected":false},"author":6,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2],"tags":[688,605,324,29,209,71,315,686,687,119,143],"ppma_author":[521],"class_list":["post-443","post","type-post","status-publish","format-standard","hentry","category-general","tag-audrey-adams","tag-coleen-hill","tag-fdc-act","tag-fda","tag-frederick-ball","tag-ivd","tag-lab","tag-lab-tests","tag-ldt","tag-rick-ball","tag-vicki-norton"],"authors":[{"term_id":521,"user_id":6,"is_guest":0,"slug":"duanemorris3","display_name":"Duane Morris","avatar_url":"https:\/\/secure.gravatar.com\/avatar\/843ff6e7a8fe5fc92109b47a45f34b6cf0ea499e6e788db23456c838b0ae6747?s=96&d=blank&r=g","0":null,"1":"","2":"","3":"","4":"","5":"","6":"","7":"","8":""}],"_links":{"self":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/443","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/comments?post=443"}],"version-history":[{"count":0,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/443\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/media?parent=443"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/categories?post=443"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/tags?post=443"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/ppma_author?post=443"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}