Amerikan G\u0131da ve \u0130laç Dairesi (“FDA”) taraf\u0131ndan derhal yürürlü\u011fe girmek üzere, s\u0131n\u0131f I ve s\u0131n\u0131fland\u0131r\u0131lmam\u0131\u015f t\u0131bbi cihazlar\u0131n ve do\u011frudan i\u015faretlemeye tabii belirli baz\u0131 t\u0131bbi cihazlar\u0131n Özgün Cihaz Tan\u0131lama Sistemi’ne uygun hale getirilme tarihlerine ili\u015fkin rehber (“Rehber”) 1 Temmuz 2020 tarihinde yay\u0131mland\u0131.<\/p>\n
Cihaz etiketi, ambalaj\u0131 ve baz\u0131 hallerde do\u011frudan cihaz üzerine ilgili cihaza özgü belirleyici eklenmesini ve cihaz bilgilerinin bir veri taban\u0131na yüklenmesini öngören Özgün Cihaz Tan\u0131lama Sistemi, ABD’de sat\u0131lan t\u0131bbi cihazlar\u0131n üretim a\u015famas\u0131ndan hasta taraf\u0131ndan kullan\u0131m\u0131na kadar tüm a\u015famalarda tespit edilebilir olmas\u0131n\u0131 amaçlamaktad\u0131r.<\/p>\n
Rehber kapsam\u0131nda, vücuda yerle\u015ftirilebilir, ya\u015fam deste\u011fi sa\u011flayan veya ya\u015famsal t\u0131bbi cihazlar d\u0131\u015f\u0131ndaki s\u0131n\u0131f I ve s\u0131n\u0131fland\u0131r\u0131lmam\u0131\u015f t\u0131bbi cihazlar\u0131n Özgün Cihaz Tan\u0131lama Sistemi kapsam\u0131nda uyum yükümlülüklerinin 24 Eylül 2022’ye kadar uygulanmamas\u0131n\u0131n de\u011ferlendirildi\u011fi aç\u0131klanm\u0131\u015ft\u0131r.<\/p>\n
Ayr\u0131ca, steril olmayan ve cihaz\u0131n do\u011frudan i\u015faretlenmesi için belirlenmi\u015f tarihten önce üretilen, etiketlenen ve stokta tutulan s\u0131n\u0131f III, ya\u015fam deste\u011fi sa\u011flayan veya ya\u015famsal ve s\u0131n\u0131f II t\u0131bbi cihazlar ile steril olmayan ve 24 Eylül 2022 tarihinden önce üretilen, etiketlenen ve stokta tutulan vücuda yerle\u015ftirilebilir, ya\u015fam deste\u011fi sa\u011flayan veya ya\u015famsal t\u0131bbi cihazlar d\u0131\u015f\u0131ndaki s\u0131n\u0131f I ve s\u0131n\u0131fland\u0131r\u0131lmam\u0131\u015f t\u0131bbi cihazlar bak\u0131m\u0131ndan do\u011frudan i\u015faretlemeye ili\u015fkin de\u011ferlendirmeye yer verilmi\u015ftir.<\/p>\n
Simge K\u0131l\u0131ç<\/p>\n","protected":false},"excerpt":{"rendered":"
Amerikan G\u0131da ve \u0130laç Dairesi (“FDA”) taraf\u0131ndan derhal yürürlü\u011fe girmek üzere, s\u0131n\u0131f I ve s\u0131n\u0131fland\u0131r\u0131lmam\u0131\u015f t\u0131bbi cihazlar\u0131n ve do\u011frudan i\u015faretlemeye … Read more<\/a><\/p>\n","protected":false},"author":1,"featured_media":7591,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[27],"tags":[],"class_list":["post-1708","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-gelisen-teknoloji","masonry-post","generate-columns","tablet-grid-50","mobile-grid-100","grid-parent","grid-33"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/herdemlaw.com\/en-us\/wp-json\/wp\/v2\/posts\/1708","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/herdemlaw.com\/en-us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/herdemlaw.com\/en-us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/herdemlaw.com\/en-us\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/herdemlaw.com\/en-us\/wp-json\/wp\/v2\/comments?post=1708"}],"version-history":[{"count":1,"href":"https:\/\/herdemlaw.com\/en-us\/wp-json\/wp\/v2\/posts\/1708\/revisions"}],"predecessor-version":[{"id":7603,"href":"https:\/\/herdemlaw.com\/en-us\/wp-json\/wp\/v2\/posts\/1708\/revisions\/7603"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/herdemlaw.com\/en-us\/wp-json\/wp\/v2\/media\/7591"}],"wp:attachment":[{"href":"https:\/\/herdemlaw.com\/en-us\/wp-json\/wp\/v2\/media?parent=1708"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/herdemlaw.com\/en-us\/wp-json\/wp\/v2\/categories?post=1708"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/herdemlaw.com\/en-us\/wp-json\/wp\/v2\/tags?post=1708"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}