{"id":126,"date":"2018-11-20T11:21:34","date_gmt":"2018-11-20T15:21:34","guid":{"rendered":"http:\/\/blogs.duanemorris.com\/lifescienceslaw\/?p=126"},"modified":"2018-11-20T11:23:54","modified_gmt":"2018-11-20T15:23:54","slug":"fda-publishes-redraft-of-510k-third-party-review-program","status":"publish","type":"post","link":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2018\/11\/20\/fda-publishes-redraft-of-510k-third-party-review-program\/","title":{"rendered":"FDA Publishes Redraft of 510(k) Third Party Review Program"},"content":{"rendered":"<p>Section 523 of the Federal Food, Drug, and Cosmetic (FD&amp;C) Act codifies the 510(k) Third Party Review Program (3P Review Program), which authorizes certain qualified third parties (<a title=\"Read more about 3P Review Organizations\" href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfThirdParty\/Accredit.cfm\" target=\"_blank\" rel=\"noopener\">3P Review Organizations<\/a>) to conduct the initial review of premarket notification submissions for certain low-to-moderate risk medical devices. The 3P Review Program has been in existence since 1996, and the Food and Drug Administration (FDA) has modified aspects of the 3P Review Program from time to time to comply with changes in the statutory framework. The FDA Reauthorization Act of 2017 (FDARA), which was signed into law on August 18, 2017, amended Section 523. In response, the FDA has now published a\u00a0<a title=\"Read new draft guidance.\" href=\"https:\/\/www.fda.gov\/downloads\/MedicalDevices\/DeviceRegulationandGuidance\/GuidanceDocuments\/UCM339697.pdf\" target=\"_blank\" rel=\"noopener\">draft guidance<\/a>, titled \u201c510(k) Third Party Review Program Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations,\u201d which modifies the 3P Review Program guidance. Comments and suggestions are due by December 13, 2018. When finalized, this guidance will supersede FDA\u2019s guidance documents from\u00a0<a title=\"Read 2001 guidance.\" href=\"https:\/\/www.fda.gov\/RegulatoryInformation\/Guidances\/ucm094450.htm\" target=\"_blank\" rel=\"noopener\">2001<\/a>\u00a0and\u00a0<a title=\"Read 2004 guidance.\" href=\"https:\/\/www.fda.gov\/MedicalDevices\/DeviceRegulationandGuidance\/GuidanceDocuments\/ucm082191.htm\" target=\"_blank\" rel=\"noopener\">2004<\/a>.<\/p>\n<p><a href=\"https:\/\/www.duanemorris.com\/alerts\/redraft_510k_third_party_review_program_1118.html\">Read the full Duane Morris <em>Alert<\/em><\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Section 523 of the Federal Food, Drug, and Cosmetic (FD&amp;C) Act codifies the 510(k) Third Party Review Program (3P Review Program), which authorizes certain qualified third parties (3P Review Organizations) to conduct the initial review of premarket notification submissions for certain low-to-moderate risk medical devices. The 3P Review Program has been in existence since 1996, &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2018\/11\/20\/fda-publishes-redraft-of-510k-third-party-review-program\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;FDA Publishes Redraft of 510(k) Third Party Review Program&#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":[325,324,29,323,119],"ppma_author":[521],"class_list":["post-126","post","type-post","status-publish","format-standard","hentry","category-general","tag-3p-review-program","tag-fdc-act","tag-fda","tag-medical-devices","tag-rick-ball"],"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\/126","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=126"}],"version-history":[{"count":0,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/126\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/media?parent=126"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/categories?post=126"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/tags?post=126"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/ppma_author?post=126"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}