{"id":4998,"date":"2020-07-01T13:06:59","date_gmt":"2020-07-01T16:06:59","guid":{"rendered":"http:\/\/passarini.com.br\/deadline-for-implementing-udi-for-class-i-devices-2\/"},"modified":"2021-09-10T22:30:24","modified_gmt":"2021-09-11T01:30:24","slug":"fda-extends-the-implementation-period-for-the-udi-rule-for-class-i-devices","status":"publish","type":"post","link":"https:\/\/passarini.com.br\/en\/fda-extends-the-implementation-period-for-the-udi-rule-for-class-i-devices\/","title":{"rendered":"FDA extends the implementation period for the UDI rule for CLASS I"},"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>FDA: implementation of the UDI rule<\/strong><\/p>\n<p>The FDA is communicating today through the publication of a new guidance, the second extension of the deadline for compliance with the UDI rule for class I and unclassified devices*, especially because of the COVID-19 pandemic. The Agency believes the policy adopted is consistent with public health interests.<\/p>\n<p>Initially, the deadline for implementing the UDI marking on the labeling of class I and unclassified devices was September 24, 2018. That deadline was extended to September 24, 2020 and today, it has been extended for another 2 years, becoming <span style=\"color: #000000;\"><strong><u>24 September 2022<\/u><\/strong><\/span>.<\/p>\n<p>In this same guidance, the FDA also eases the commercialization of class I and unclassified devices <u>manufactured before<\/u> September 24, 2018 (inventory), which can now be sold without complying with the UDI rule until September 24, 2022.<\/p>\n<p>Changes were also made to the UDI deadlines for direct marking for class II, III and implantable or life support devices that make up the inventory. The deadline for implementing UDI direct marking remains September 24, 2022.<\/p>\n<h2>Check out the full guidance on the subjec, <span style=\"color: #0000ff;\"><strong><a style=\"color: #0000ff;\" href=\"http:\/\/passarini.com.br\/wp-content\/uploads\/2020\/07\/UDI-Policy-regarding-compliance-dates-dor-class-I-and-unclassified-devices.pdf\">click here<\/a><\/strong><\/span>.<\/h2>\n<p>Do you have doubts about the UDI rule? 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: 07\/01\/2020<\/p>\n<h6>*Unclassified devices are those for which a classification regulation has not been promulgated.<\/h6>\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=\"FDA: implementation of the UDI rule\r\n\r\nThe FDA is communicating today through the publication of a new guidance, the second extension of the deadline for compliance with the UDI rule for class I and unclassified devices*, especially because of the COVID-19 pandemic. 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