{"id":388,"date":"2023-08-16T15:50:15","date_gmt":"2023-08-16T19:50:15","guid":{"rendered":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/?p=388"},"modified":"2023-08-16T15:52:13","modified_gmt":"2023-08-16T19:52:13","slug":"fda-drafts-guidance-on-pre-market-submissions-for-patient-matched-guides-to-orthopedic-implants","status":"publish","type":"post","link":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2023\/08\/16\/fda-drafts-guidance-on-pre-market-submissions-for-patient-matched-guides-to-orthopedic-implants\/","title":{"rendered":"FDA Drafts Guidance on Pre-market Submissions for Patient-Matched Guides to Orthopedic Implants"},"content":{"rendered":"<p>This summer, the U.S. Food and Drug Administration (FDA) issued\u00a0<a href=\"https:\/\/www.fda.gov\/media\/169792\/download\" target=\"_blank\" rel=\"noopener\">draft guidance<\/a> regarding patient-matched guides to orthopedic implants, which are intended to assist in the execution of a pre-surgical plan concurred upon by the patient\u2019s healthcare professional to position an orthopedic implant in a way consistent with the implant\u2019s indicated use. In the draft guidance, FDA recommends information to include in pre-market submissions for patient-matched guides to orthopedic implants. FDA also suggests information for manufacturers to consider when creating the design process for patient-matched guides.<\/p>\n<p>To read the full alert, visit the <a href=\"https:\/\/www.duanemorris.com\/alerts\/fda_issues_draft_guidance_premarket_submissions_patient_matched_guides_orthopedic_implants_0823.html\">Duane Morris website<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>This summer, the U.S. Food and Drug Administration (FDA) issued\u00a0draft guidance regarding patient-matched guides to orthopedic implants, which are intended to assist in the execution of a pre-surgical plan concurred upon by the patient\u2019s healthcare professional to position an orthopedic implant in a way consistent with the implant\u2019s indicated use. In the draft guidance, FDA &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2023\/08\/16\/fda-drafts-guidance-on-pre-market-submissions-for-patient-matched-guides-to-orthopedic-implants\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;FDA Drafts Guidance on Pre-market Submissions for Patient-Matched Guides to Orthopedic Implants&#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":[],"ppma_author":[521],"class_list":["post-388","post","type-post","status-publish","format-standard","hentry","category-general"],"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\/388","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=388"}],"version-history":[{"count":0,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/388\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/media?parent=388"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/categories?post=388"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/tags?post=388"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/ppma_author?post=388"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}