{"id":4965,"date":"2020-06-05T16:50:00","date_gmt":"2020-06-05T19:50:00","guid":{"rendered":"http:\/\/passarini.com.br\/electronic-format-with-fda-2\/"},"modified":"2021-11-16T10:22:33","modified_gmt":"2021-11-16T13:22:33","slug":"deadline-for-implementing-udi-for-class-i-devices","status":"publish","type":"post","link":"https:\/\/passarini.com.br\/en\/deadline-for-implementing-udi-for-class-i-devices\/","title":{"rendered":"Deadline for implementing UDI for CLASS I devices"},"content":{"rendered":"<p><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 hundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-background-position:left center;--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:0px;--awb-padding-right:0px;--awb-padding-bottom:0px;--awb-padding-left:0px;--awb-margin-top:0px;--awb-margin-bottom:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-one-full fusion-column-first fusion-column-last\" style=\"--awb-padding-top:0px;--awb-padding-right:0px;--awb-padding-bottom:0px;--awb-padding-left:0px;--awb-bg-size:cover;--awb-margin-bottom:0px;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\"><div class=\"fusion-slider-sc fusion-flexslider-loading flexslider flexslider-hover-type-none\" data-slideshow_autoplay=\"1\" data-slideshow_smooth_height=\"0\" data-slideshow_speed=\"7000\" style=\"max-width:100%;height:100%;\"><ul class=\"slides\"><li class=\"image\"><span class=\"fusion-image-hover-element hover-type-none\"><img decoding=\"async\" src=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2020\/10\/1920x500_informativos_noticias-1.webp\" alt=\"NEWLESTTER\" width=\"1920\" height=\"500\" class=\"wp-image-7069\" srcset=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2020\/10\/1920x500_informativos_noticias-1-200x52.webp 200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2020\/10\/1920x500_informativos_noticias-1-300x78.webp 300w, https:\/\/passarini.com.br\/wp-content\/uploads\/2020\/10\/1920x500_informativos_noticias-1-400x104.webp 400w, https:\/\/passarini.com.br\/wp-content\/uploads\/2020\/10\/1920x500_informativos_noticias-1-600x156.webp 600w, https:\/\/passarini.com.br\/wp-content\/uploads\/2020\/10\/1920x500_informativos_noticias-1-768x200.webp 768w, https:\/\/passarini.com.br\/wp-content\/uploads\/2020\/10\/1920x500_informativos_noticias-1-800x208.webp 800w, https:\/\/passarini.com.br\/wp-content\/uploads\/2020\/10\/1920x500_informativos_noticias-1-1024x267.webp 1024w, https:\/\/passarini.com.br\/wp-content\/uploads\/2020\/10\/1920x500_informativos_noticias-1-1200x313.webp 1200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2020\/10\/1920x500_informativos_noticias-1-1536x400.webp 1536w, https:\/\/passarini.com.br\/wp-content\/uploads\/2020\/10\/1920x500_informativos_noticias-1.webp 1920w\" sizes=\"(max-width: 800px) 100vw, 1200px\" \/><\/span><\/li><\/ul><\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:10px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_3_4 3_4 fusion-three-fourth fusion-column-first\" style=\"--awb-bg-size:cover;width:75%;width:calc(75% - ( ( 4% ) * 0.75 ) );margin-right: 4%;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\"><div class=\"fusion-text fusion-text-1\"><p><strong>The DEADLINE for implementing UDI for CLASS I devices before FDA is CLOSE! <\/strong><\/p>\n<p>Under FDA, compliance with the UDI rule for class I devices becomes mandatory as of September 24, 2020. That date that was initially, September 24, 2018, has already been postponed by 2 years. So be careful, there are just over 3 months left!<\/p>\n<p>The UDI rule applies to medical devices that are being marketed in the U.S. Remembering, the UDI rule consists of the UDI implementation in two formats on the device packaging, adequacy of the date formats and feeding of the UDI database (GUDID). For Class II devices, which in the vast majority are eligible for 510 (k), the UDI rule has been mandatory since September 24, 2016.<\/p>\n<p>Failure to comply with the UDI rule is a violation of the Federal Food, Drug and Cosmetic Act and is liable to penalties that include, but are not limited to, misbranding, seizure, recall, and applicable civil and criminal penalties.<\/p>\n<h6>Note: This implementation deadline does not apply to implantable, life support or life sustainable class I devices.<\/h6>\n<p>RA Passarini can help you, talk to us!<\/p>\n<p>Contact us: <a href=\"mailto:contato@passarini.com.br\">contato@passarini.com.br<\/a><\/p>\n<p>We are ready to help you.<\/p>\n<p><span style=\"color: #000000;\"><strong>Passarini Regulatory Affairs<\/strong><\/span><\/p>\n<p>Published: 06\/05\/2020<\/p>\n<\/div><div class=\"fusion-sharing-box fusion-sharing-box-1 boxed-icons has-taglines layout-floated layout-medium-floated layout-small-floated\" style=\"background-color:#f6f6f6;--awb-layout:row;--awb-alignment-small:space-between;\" data-title=\"Passarini Regulatory Affairs\" data-description=\"The DEADLINE for implementing UDI for CLASS I devices before FDA is CLOSE! \r\n\r\nUnder FDA, compliance with the UDI rule for class I devices becomes mandatory as of September 24, 2020. That date that was initially, September 24, 2018, has already been postponed by 2 years. 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class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":4843,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[73,79,159,83],"tags":[154,82,155,149,161,81],"class_list":["post-4965","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cheers","category-fda-en","category-regulatory","category-usa","tag-cheers","tag-fda-en","tag-health","tag-regulatory","tag-regulatory-affairs","tag-usa-en"],"_links":{"self":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/4965","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/comments?post=4965"}],"version-history":[{"count":8,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/4965\/revisions"}],"predecessor-version":[{"id":7078,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/4965\/revisions\/7078"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/media\/4843"}],"wp:attachment":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/media?parent=4965"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/categories?post=4965"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/tags?post=4965"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}