{"id":471,"date":"2024-09-23T14:49:57","date_gmt":"2024-09-23T18:49:57","guid":{"rendered":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/?p=471"},"modified":"2024-09-23T14:49:57","modified_gmt":"2024-09-23T18:49:57","slug":"fdas-latest-draft-guidance-on-medical-device-pccps-incorporates-fdc-act-changes","status":"publish","type":"post","link":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2024\/09\/23\/fdas-latest-draft-guidance-on-medical-device-pccps-incorporates-fdc-act-changes\/","title":{"rendered":"FDA&#8217;s Latest Draft Guidance on Medical Device PCCPs Incorporates FD&amp;C Act Changes"},"content":{"rendered":"\n<p>The U.S. Food and Drug Administration (FDA) recently issued&nbsp;<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/predetermined-change-control-plans-medical-devices\" target=\"_blank\" rel=\"noreferrer noopener\">draft Guidance<\/a>&nbsp;informing medical device manufacturers how to structure a predetermined change control plan (PCCP) to describe appropriate, intended future device modifications. The Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research in consultation with the Center for Drug Evaluation and Research and the Office of Combination Products in the Office of the Commissioner worked together to prepare this Guidance.<\/p>\n\n\n\n<p>Read the full <em>Alert<\/em> on the <a href=\"https:\/\/www.duanemorris.com\/alerts\/fda_issues_draft_guidance_predetermined_change_control_plans_medical_devices_0924.html\">Duane Morris LLP website<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The U.S. Food and Drug Administration (FDA) recently issued&nbsp;draft Guidance&nbsp;informing medical device manufacturers how to structure a predetermined change control plan (PCCP) to describe appropriate, intended future device modifications. The Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research in consultation with the Center for Drug Evaluation and Research and &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2024\/09\/23\/fdas-latest-draft-guidance-on-medical-device-pccps-incorporates-fdc-act-changes\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;FDA&#8217;s Latest Draft Guidance on Medical Device PCCPs Incorporates FD&amp;C Act Changes&#8221;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":[605,491,29,209,323,706,462],"ppma_author":[521],"class_list":["post-471","post","type-post","status-publish","format-standard","hentry","category-general","tag-coleen-hill","tag-draft-guidance","tag-fda","tag-frederick-ball","tag-medical-devices","tag-pccps","tag-sean-burke"],"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\/471","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=471"}],"version-history":[{"count":0,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/471\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/media?parent=471"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/categories?post=471"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/tags?post=471"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/ppma_author?post=471"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}