{"id":4847,"date":"2019-12-19T14:44:51","date_gmt":"2019-12-19T16:44:51","guid":{"rendered":"http:\/\/passarini.com.br\/the-fda-and-its-peculiarities-in-the-cleaning-and-steam-sterilization-processes-recommended-in-the-ifu-2\/"},"modified":"2021-09-19T17:59:51","modified_gmt":"2021-09-19T20:59:51","slug":"electronic-format-with-fda","status":"publish","type":"post","link":"https:\/\/passarini.com.br\/en\/electronic-format-with-fda\/","title":{"rendered":"Electronic format with FDA"},"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>Medical devices submissions pass to electronic format with FDA<\/strong><\/p>\n<p>In an effort to improve the effectiveness of the medical device-related pre-market submission program, the <a href=\"https:\/\/passarini.com.br\/en\/portfolio-items\/fda-registration\/\">FDA<\/a> today issued the Final Rule, which amends existing pre-market regulations and now requires that submissions only occur in electronic format, eliminating the need for multiple paper copies. Such rule shall enter into force 30 days from its publication (12\/16\/2019).<\/p>\n<p>At the same time, the FDA has provided the Guidance \u201ceCopy Program for Medical Device Submissions\u201d guide to clarify and guide the regulated industry on the new format of submissions, <span style=\"color: #0000ff;\"><a style=\"color: #0000ff;\" href=\"http:\/\/passarini.com.br\/wp-content\/uploads\/2019\/12\/Program-for-Medical-Device-Submissions.pdf\"><strong>click here<\/strong><\/a><\/span>.<\/p>\n<p>Electronic copy (eCopy) is an electronic version of the submission of your medical device created and sent to the Agency on a CD, DVD or flash drive. ECopy must be accompanied of a cover letter in paper. The signature of this letter can be by hand (ie ink) or by means of a valid digital signature.<\/p>\n<p>Do you intend to enter the US market?<\/p>\n<p>Contact us.<\/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: 12\/16\/2019<\/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=\"Medical devices submissions pass to electronic format with FDA\r\n\r\nIn an effort to improve the effectiveness of the medical device-related pre-market submission program, the FDA today issued the Final Rule, which amends existing pre-market regulations and now requires that submissions only occur in electronic format, eliminating the need for multiple paper\" data-link=\"http:\/\/passarini.com.br\/en\/electronic-format-with-fda\/\"><h4 class=\"tagline\" style=\"color:#333333;\">To share<\/h4><div class=\"fusion-social-networks sharingbox-shortcode-icon-wrapper sharingbox-shortcode-icon-wrapper-1 boxed-icons\"><span><a href=\"https:\/\/www.facebook.com\/sharer.php?u=http%3A%2F%2Fpassarini.com.br%2Fen%2Felectronic-format-with-fda%2F&amp;t=Passarini%20Regulatory%20Affairs\" target=\"_blank\" rel=\"noreferrer\" title=\"Facebook\" aria-label=\"Facebook\" data-placement=\"top\" data-toggle=\"tooltip\" data-title=\"Facebook\"><i class=\"fusion-social-network-icon fusion-tooltip fusion-facebook awb-icon-facebook\" style=\"color:#ffffff;background-color:#3b5998;border-color:#3b5998;border-radius:4px;\" aria-hidden=\"true\"><\/i><\/a><\/span><span><a href=\"https:\/\/x.com\/intent\/post?text=Passarini%20Regulatory%20Affairs&amp;url=http%3A%2F%2Fpassarini.com.br%2Fen%2Felectronic-format-with-fda%2F\" target=\"_blank\" rel=\"noopener noreferrer\" 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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-4847","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\/4847","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=4847"}],"version-history":[{"count":8,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/4847\/revisions"}],"predecessor-version":[{"id":7124,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/4847\/revisions\/7124"}],"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=4847"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/categories?post=4847"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/tags?post=4847"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}