{"id":30925,"date":"2023-10-20T17:25:49","date_gmt":"2023-10-20T15:25:49","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=30925"},"modified":"2024-01-16T15:34:13","modified_gmt":"2024-01-16T14:34:13","slug":"usa-510k-submission-only-with-estar-portal","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/en\/2023\/10\/20\/usa-510k-submission-only-with-estar-portal\/","title":{"rendered":"USA: 510(K) Submission Only With eSTAR Portal"},"content":{"rendered":"<h2>On October 2, 2023, the FDA \u00a0published an update to the <a href=\"https:\/\/www.fda.gov\/media\/152429\/download\"><em>Electronic Submission Template for Medical Device 510(k) Submissions<\/em><\/a>\u00a0guidance:<a href=\"https:\/\/www.fda.gov\/media\/152429\/download\"><em> Guidance for Industry and FDA Staff<\/em><\/a> since as of October 1, 2023, all 510(k) submissions, unless exempted, must be submitted using the <strong>eSTAR<\/strong> <strong>portal<\/strong> (electronic Submission Template And Resource).<\/h2>\n<p>&nbsp;<\/p>\n<p>Applicants must implement the requirements of <strong>Section 745A(b)(B) of the FD&amp;C Act<\/strong> which require that all 510(k) submissions &#8211; traditional, special and abbreviated<em> &#8211;<\/em> and subsequent supplements or amendments, unless exempt under Section VI, must be submitted through eSTAR.<\/p>\n<p>The guideline in Table 1 gives a high-level overview of the <strong>structure <\/strong>of the current electronic submission template for 510(k) files and a <strong>summary <\/strong>of the expected content of the submission.<\/p>\n<p>The eSTAR format, compared to its predecessor eSubmitter, has several <strong>advantages<\/strong> including an <strong>easy-to-use<\/strong> software that does not require special training, more dynamic functions such as support for images and messages with hyperlinks, compatibility with mobile devices and the possibility for users to add comments to PDF documents. In addition, the content of eSTAR fully reflects the internal templates used by reviewers, thus favouring the completeness of the content of the presentation and facilitating its review.<\/p>\n<p>FDA therefore identified <strong>October 1, 2023<\/strong> as the effective date for the requirements for electronic submission of 510(k) applications via the eSTAR portal.<\/p>\n<p>&gt;&gt;&gt;\u00a0Through the services of <a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/consulenza-strategico-regolatoria-dispositivi-medici-medical-devices\/\"><strong>strategic-regulatory consulting<\/strong><\/a>, <a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/registrazioni-internazionali-extra-ue-dispositivi-medici-dm-e-medico-diagnostici-in-vitro-ivd\/\"><strong>510(k) pre-market notification, De Novo and Premarket approval (PMA)<\/strong><\/a> drafting, Thema can support the marketing of medical devices in the U.S.A. while complying with FDA requirements.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Source<\/strong>:<\/p>\n<p><a href=\"https:\/\/www.fda.gov\/media\/152429\/download\"><em>Electronic Submission Template for Medical Device 510(k) Submissions:<\/em><\/a><a href=\"https:\/\/www.fda.gov\/media\/152429\/download\"><em> Guidance for Industry and FDA Staff<\/em><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On October 2, 2023, the FDA \u00a0published an update to the Electronic Submission Template for Medical Device 510(k) Submissions\u00a0guidance: Guidance for  [&#8230;]<\/p>\n","protected":false},"author":115,"featured_media":30922,"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-30925","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en","tag-usa-topic"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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