{"id":404,"date":"2023-09-27T11:12:42","date_gmt":"2023-09-27T15:12:42","guid":{"rendered":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/?p=404"},"modified":"2023-09-27T11:19:04","modified_gmt":"2023-09-27T15:19:04","slug":"fda-proposes-transformative-new-steps-to-510k-path","status":"publish","type":"post","link":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2023\/09\/27\/fda-proposes-transformative-new-steps-to-510k-path\/","title":{"rendered":"FDA Proposes Updates to 510(k) Path"},"content":{"rendered":"<p>On September 6, 2023, the FDA\u00a0<a href=\"https:\/\/www.fda.gov\/medical-devices\/medical-devices-news-and-events\/cdrh-statement-fda-continues-take-steps-strengthen-premarket-notification-510k-program\" target=\"_blank\" rel=\"noopener\">released<\/a>\u00a0three draft guidance documents that seek to \u201cmodernize\u201d the 510(k) premarket notification process.\u00a0 Ever since the FDA first proposed \u201c<a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/statement-fda-commissioner-scott-gottlieb-md-and-jeff-shuren-md-director-center-devices-and\" target=\"_blank\" rel=\"noopener\">transformative new steps<\/a>\u201d to the program in 2018, the agency has promised to further update the 510(k) clearance pathway in an effort to better balance technological innovation and patient safety.\u00a0 In issuing these draft guidance documents, the FDA has followed through on that promise.<\/p>\n<p><strong><a href=\"https:\/\/blogs.duanemorris.com\/productsliability\/2023\/09\/27\/fda-releases-new-draft-guidance-documents-to-modernize-the-510k-process\/\" target=\"_blank\" rel=\"noopener\">Read more on the Products Liability Blog.<\/a><\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On September 6, 2023, the FDA\u00a0released\u00a0three draft guidance documents that seek to \u201cmodernize\u201d the 510(k) premarket notification process.\u00a0 Ever since the FDA first proposed \u201ctransformative new steps\u201d to the program in 2018, the agency has promised to further update the 510(k) clearance pathway in an effort to better balance technological innovation and patient safety.\u00a0 In &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2023\/09\/27\/fda-proposes-transformative-new-steps-to-510k-path\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;FDA Proposes Updates to 510(k) Path&#8221;<\/span><\/a><\/p>\n","protected":false},"author":662,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2],"tags":[424,29,371,676],"ppma_author":[675],"class_list":["post-404","post","type-post","status-publish","format-standard","hentry","category-general","tag-501k","tag-fda","tag-products-liability","tag-will-heaston"],"authors":[{"term_id":675,"user_id":662,"is_guest":0,"slug":"wheaston","display_name":"Will Heaston","avatar_url":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-content\/uploads\/sites\/15\/2023\/09\/heastonwilliam-100x100.jpg","0":null,"1":"","2":"","3":"","4":"","5":"","6":"","7":"","8":""}],"_links":{"self":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/404","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\/662"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/comments?post=404"}],"version-history":[{"count":0,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/404\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/media?parent=404"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/categories?post=404"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/tags?post=404"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/ppma_author?post=404"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}