{"id":15161,"date":"2020-08-05T13:48:14","date_gmt":"2020-08-05T11:48:14","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=15161"},"modified":"2023-12-12T16:07:56","modified_gmt":"2023-12-12T15:07:56","slug":"fda-guideline-electronic-format-sending-for-medical-devices","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2020\/08\/05\/fda-guideline-electronic-format-sending-for-medical-devices\/","title":{"rendered":"USA: FDA guideline on electronic format sending for medical devices"},"content":{"rendered":"\n<p>The FDA guideline <strong>\u201cProviding Regulatory Submissions for Medical Devices in Electronic Format &#8211; Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act\u201d<\/strong> on electronic submission for medical devices was published on July 15, 2020.<\/p>\n\n\n\n<p>The FDA document defines which submissions can be made\nelectronically and the criteria for possible exemptions under <strong>Section 745A(b)<\/strong> of the Federal Food,\nDrug and Cosmetic Act.<\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/08\/usa-guida-fda-invio-elettronico-1024x536.png\" alt=\"FDA guideline on electronic format sending for medical devices\" class=\"wp-image-15147\"\/><figcaption>FDA guideline on electronic format sending for medical devices<\/figcaption><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>FDA guideline: what are electronic mailings?<\/strong><\/h2>\n\n\n\n<p><strong>Section III.A<\/strong> of the new FDA guidance clarifies what\nmailings can be submitted in electronic format:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Pre-market\nnotifications [510(k)].<\/li><li>Evaluation\nof Automatic Designation Application (De Novo) [513(f) (2)].<\/li><li>Pre-market\napproval (PMA).<\/li><li>Product\ndevelopment protocols.<\/li><li>Requests\nfor exemption for clinical investigation devices.<\/li><li>Requests\nfor exemption for humanitarian devices.<\/li><li>Emergency\nUse Authorizations (EUA).<\/li><li>Some\ninvestigational applications for new drugs (IND).<\/li><li>Biological\nLicense Applications (BLA).<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>When will electronic submission be mandatory?<\/strong><\/h2>\n\n\n\n<p>At the moment, no definite date has been set. However, in\nthe meantime, the FDA is working on developing individual guidelines to specify\nthe electronic format and scope of applicability of these submissions. These <strong>guidance documents<\/strong> will be published\nsequentially on the FDA website. <\/p>\n\n\n\n<p>Once the guidance draft has been reviewed, the final\nguideline on electronic submissions will be ready and published on the FDA\nwebsite.<\/p>\n\n\n\n<p class=\"has-medium-font-size\"><strong>Would you\nlike more information?<\/strong><\/p>\n\n\n\n<p>Thema offers <a href=\"https:\/\/www.thema-med.com\/en\/services\/strategic-regulatory-consulting-2\/\"><strong>strategic-regulatory consulting services<\/strong><\/a> to manufacturers and distributors of <strong>Medical Devices <\/strong>(MD) and<strong> In Vitro Diagnostic Medical Devices <\/strong>(IVD) on national and international markets.<\/p>\n\n\n\n<p>Thema\u2019s objective is to provide <strong>support to Customers<\/strong> in achieving their business goals thanks to a reliable and competent partnership in the regulatory field.<\/p>\n\n\n\n<p>Thanks to a network of partner agencies, Thema provides a <strong><a href=\"https:\/\/www.thema-med.com\/en\/services\/international-registrations-outside-the-eu\/\">series of services<\/a><\/strong> to offer the right support in the registration of medical devices and in vitro diagnostic medical devices with foreign Regulatory Authorities. <\/p>\n\n\n\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-text-color has-background\" href=\"mailto:sales@thema-group.it\" style=\"background-color:#0099a8;color:#ffffff\"><strong>Contact us to schedule a consultation!&nbsp;  <\/strong><\/a><\/div>\n\n\n\n<p><em>Source:  <\/em><\/p>\n\n\n\n<p><a href=\"https:\/\/www.fda.gov\/media\/131064\/download\">https:\/\/www.fda.gov\/media\/131064\/download<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The FDA guideline \u201cProviding Regulatory Submissions for Medical Devices in Electronic Format &#8211; Submissions Under Section 745A(b) of the Federal Food,  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[2],"tags":[1568],"class_list":["post-15161","post","type-post","status-publish","format-standard","hentry","category-news-en","tag-usa-topic"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>USA: FDA guideline on electronic format sending for medical devices<\/title>\n<meta name=\"description\" content=\"The FDA guideline has been published that defines what are the submissions that can be made electronically for medical devices ...\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, 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