{"id":11401,"date":"2011-09-01T13:38:34","date_gmt":"2011-09-01T17:38:34","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=interventional&p=11401"},"modified":"2011-09-01T13:38:34","modified_gmt":"2011-09-01T17:38:34","slug":"how-is-tavi-like-a-european-toaster","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2011\/09\/01\/how-is-tavi-like-a-european-toaster\/","title":{"rendered":"How Is TAVI Like a European Toaster?"},"content":{"rendered":"

Approval of TAVI and electric toasters is governed by the same regulatory framework in Europe, the \u201cCE mark\u201d \u2014 a mandatory conformity stamp for products placed on the market in the European Economic Area.<\/p>\n

Because high-tech (and low-tech) devices are approved in Europe faster than in the United States, many companies and consumers scold the FDA for taking so long to evaluate products. Some are urging a more \u201cEuropean approach.\u201d<\/p>\n

How does the European regulatory process stack up?<\/p>\n

    \n
  1. Manufacturers that sell devices in Europe must satisfy the “essential requirements” of safety and performance, but they do not necessarily need to show that a device benefits patients.<\/li>\n
  2. Clinical efficacy trials are often performed after approval in Europe<\/strong> (but before approval in the United States).<\/li>\n
  3. Isolated instances of device complications have disproportionately occurred in countries (i.e., in Europe) that grant earlier approval.<\/li>\n
  4. Unlike the U.S., Europe has no centralized process for approving medical devices, so manufacturers are free to seek approval from any EU country. In other words, manufacturers can choose agencies that offer the least-burdensome and fastest reviews.<\/li>\n<\/ol>\n

    So does this make you feel better about your toast or more concerned about your TAVI?<\/strong><\/p>\n

    All things considered, do we really want to be more European?<\/strong><\/p>\n

    Editor’s Note: This post is a response to one by Stephen Fleet titled “TAVI–When Will It Come to an Operating Theater Near Me?”<\/a><\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

    Approval of TAVI and electric toasters is governed by the same regulatory framework in Europe, the \u201cCE mark\u201d \u2014 a mandatory conformity stamp for products placed on the market in the European Economic Area. Because high-tech (and low-tech) devices are approved in Europe faster than in the United States, many companies and consumers scold the […]<\/p>\n","protected":false},"author":214,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[9],"tags":[326,196,222,423],"class_list":["post-11401","post","type-post","status-publish","format-standard","hentry","category-interventional-cardiology","tag-esc","tag-fda","tag-fda-approvals","tag-tavi"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/11401","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/users\/214"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=11401"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/11401\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=11401"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=11401"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=11401"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}