{"id":259,"date":"2020-10-06T16:31:22","date_gmt":"2020-10-06T20:31:22","guid":{"rendered":"http:\/\/blogs.duanemorris.com\/lifescienceslaw\/?p=259"},"modified":"2020-10-06T16:33:34","modified_gmt":"2020-10-06T20:33:34","slug":"fda-clarifies-evidence-used-to-determine-intended-use-of-medical-products","status":"publish","type":"post","link":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2020\/10\/06\/fda-clarifies-evidence-used-to-determine-intended-use-of-medical-products\/","title":{"rendered":"FDA Clarifies Evidence Used to Determine &#8220;Intended Use&#8221; of Medical Products"},"content":{"rendered":"<p>On September 23, 2020, the U.S. Food and Drug Administration (FDA) published a\u00a0<a title=\"Regulations Regarding \u2018\u2018Intended Uses\u2019\u2019\" href=\"https:\/\/www.govinfo.gov\/content\/pkg\/FR-2020-09-23\/pdf\/2020-20437.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">proposed rule<\/a>\u00a0amending the agency\u2019s regulations concerning \u201cintended uses.\u201d While the proposed rule does not signal a fundamental change in FDA\u2019s position that\u00a0<i>all\u00a0<\/i>relevant sources of evidence may be considered, it attempts to make clear what sort of evidence is not on its own sufficient to demonstrate a product\u2019s intended use.<\/p>\n<p>To read the full text of this Duane Morris\u00a0<em>Alert<\/em>, please\u00a0<a href=\"https:\/\/www.duanemorris.com\/alerts\/fda_clarifies_types_evidence_it_will_consider_when_determining_medical_products_intended_1020.html\">visit the firm website<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>On September 23, 2020, the U.S. Food and Drug Administration (FDA) published a\u00a0proposed rule\u00a0amending the agency\u2019s regulations concerning \u201cintended uses.\u201d While the proposed rule does not signal a fundamental change in FDA\u2019s position that\u00a0all\u00a0relevant sources of evidence may be considered, it attempts to make clear what sort of evidence is not on its own sufficient &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2020\/10\/06\/fda-clarifies-evidence-used-to-determine-intended-use-of-medical-products\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;FDA Clarifies Evidence Used to Determine &#8220;Intended Use&#8221; of Medical Products&#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":[29,209,388,499,500],"ppma_author":[521],"class_list":["post-259","post","type-post","status-publish","format-standard","hentry","category-general","tag-fda","tag-frederick-ball","tag-justin-stern","tag-medical-product","tag-proposed-rule"],"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","author_category":"1","last_name":"Sullivan","first_name":"Margaret","job_title":"","user_url":"http:\/\/www.duanemorris.com","description":"<a href=\"http:\/\/www.duanemorris.com\">Visit the Duane Morris website.<\/a>"}],"_links":{"self":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/259","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=259"}],"version-history":[{"count":0,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/259\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/media?parent=259"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/categories?post=259"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/tags?post=259"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/ppma_author?post=259"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}