{"id":14833,"date":"2020-06-29T13:13:03","date_gmt":"2020-06-29T11:13:03","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=14833"},"modified":"2020-06-29T13:13:03","modified_gmt":"2020-06-29T11:13:03","slug":"fda-starts-estar-pilot-program-for-procedure-510-k","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2020\/06\/29\/fda-starts-estar-pilot-program-for-procedure-510-k\/","title":{"rendered":"FDA starts eSTAR pilot program for procedure 510 (k)"},"content":{"rendered":"\n<p><strong>FDA periodically starts pilot programs <\/strong>in order to help <strong>improve coherence<\/strong> and <strong>efficiency<\/strong> in procedure <strong>510 (k).<\/strong> Those programs are intended to help both industry and FDA staff to use the resources effectively. <br><strong>eSTAR<\/strong> <strong>pilot program<\/strong> (electronic Submission Template And Resource) is a <strong>template of electronic sending in PDF<\/strong>, offered by FDA that guides the participants selected in the pilot project to prepare 510 (k). <\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/06\/FDA-avvia-programma-pilota-eSTAR-per-510k-1024x536.png\" alt=\"FDA starts eSTAR pilot program for procedure 510 (k) medical devices\" class=\"wp-image-14814\"\/><figcaption>FDA starts eSTAR pilot program for procedure 510 (k)<\/figcaption><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Advantages of the eSTAR pilot program <\/strong><\/h2>\n\n\n\n<p>The eSTAR pilot\nprogram includes benefits similar to the eSubmitter program, like: automation,\ncontent and structure complementary to CDRH internal audit models, integration of\nmore resources, guided construction for each presentation section, automatic\nverification, free of charge. <\/p>\n\n\n\n<p><strong>eSTAR additional advantages <\/strong>are: more intuitive interface, no\ninstallation of special software (if the user already has Adobe Acrobat or\nsimilar software), support for dynamic pop-up images and messages, mobile\ndevice and Apple iOS support, opportunity to comment once converted in static\nPDF and the ability to share an eSTAR file under construction.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>How is eSTAR different from eSubmitter?<\/strong><\/h2>\n\n\n\n<p><strong>eSTAR is designed differently from eSubmitter, <\/strong>because through a collection of questions\nand instructions that guide the user, it can improve the efficiency with which\nthe medical devices industry prepares and sends a 510 (k). Moreover, its\nfunctionality and its content are embedded in a PDF that allows the sector\ngreater flexibility during the development, display and modification of a 510\n(k). <\/p>\n\n\n\n<p>FDA assesses\nwhether the use of eSTAR produces well-organized submissions, compared to\nprepared submissions such as eCopy or with the eSubmitter application, to make\nmedical devices accessible in a timely, safe and effective way. <\/p>\n\n\n\n<p><strong>The eSTAR pilot program started on February 27, 2020. <\/strong>At the moment, FDA has selected nine\nparticipants who provide a general representation of the medical device sector\nand who satisfy the selection criteria set out in the Notice of the Federal\nRegistry. <\/p>\n\n\n\n<p><strong>For more information see our section <\/strong><a href=\"https:\/\/www.thema-med.com\/en\/what-is-the-510\/\"><strong>FAQ How to register medical devices in the world \u2013 What is the 510 (k)?<\/strong><\/a><strong> and contact us at <\/strong><a href=\"mailto:sales@thema-group.it\"><strong>sales@thema-group.it<\/strong><\/a><strong> to know Thema services on the <\/strong><a href=\"https:\/\/www.thema-med.com\/en\/services\/international-registrations-outside-the-eu\/\"><strong>extra-EU international registrations<\/strong><\/a><strong>. <\/strong><\/p>\n\n\n\n<p><em>Source: <\/em> <\/p>\n\n\n\n<p><a href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-notification-510k\/510k-program-pilots\">https:\/\/www.fda.gov\/medical-devices\/premarket-notification-510k\/510k-program-pilots<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>FDA periodically starts pilot programs in order to help improve coherence and efficiency in procedure 510 (k). Those programs are intended  [&#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":[23],"tags":[],"class_list":["post-14833","post","type-post","status-publish","format-standard","hentry","category-us-agent"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA starts eSTAR pilot program for procedure 510 (k)<\/title>\n<meta name=\"description\" content=\"FDA starts eSTAR pilot program to help improve coherence and efficiency in procedure 510 (k). \ufeffeSTAR is a template of electronic sending in PDF...\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, 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