The 510(k) process provides a review procedure for marketing clearance of devices that are \u201csubstantially equivalent\u201d to other approved devices or to a standard recognized by the Food and Drug Administration (FDA).<\/p>\n
On September 6, 2018, the FDA launched an alternate to the Traditional 510(k) for submitting a Premarket Notification (510(k)). The FDA calls the alternative the\u00a0Quality in 510(k) \u201cQuik\u201d<\/a>\u00a0Review Program Pilot. Under the program, the FDA\u2019s goal is \u201cto make a final decision within 60 days.\u201d<\/p>\n Read the full text of this Alert on the Duane Morris LLP website<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":" The 510(k) process provides a review procedure for marketing clearance of devices that are \u201csubstantially equivalent\u201d to other approved devices or to a standard recognized by the Food and Drug Administration (FDA). On September 6, 2018, the FDA launched an alternate to the Traditional 510(k) for submitting a Premarket Notification (510(k)). The FDA calls the … <\/p>\n Continue reading “FDA Rolls Out Pilot of New Quality in 510(k) “Quik” Review Program”<\/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":[303,29,75,302,119],"ppma_author":[521],"class_list":["post-110","post","type-post","status-publish","format-standard","hentry","category-general","tag-510k","tag-fda","tag-medical-device","tag-quik-review-program","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","author_category":"1","last_name":"Sullivan","first_name":"Margaret","job_title":"","user_url":"http:\/\/www.duanemorris.com","description":"Visit the Duane Morris website.<\/a>"}],"_links":{"self":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/110","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=110"}],"version-history":[{"count":0,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/110\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/media?parent=110"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/categories?post=110"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/tags?post=110"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/ppma_author?post=110"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}