{"id":15067,"date":"2020-07-20T14:23:18","date_gmt":"2020-07-20T12:23:18","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=15067"},"modified":"2023-01-24T14:59:07","modified_gmt":"2023-01-24T13:59:07","slug":"fda-postpones-to-september-24-2022-the-udi-for-class-i-and-unclassified","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2020\/07\/20\/fda-postpones-to-september-24-2022-the-udi-for-class-i-and-unclassified\/","title":{"rendered":"FDA postpones to September 24, 2022 the UDI for Class I and Unclassified"},"content":{"rendered":"\n<p>On July 1, 2020, FDA published the <strong>update <\/strong>of the \u201cUnique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking\u201d guide that provides for the <strong>postponement to September 24, 2022<\/strong> of the <strong>UDI requirements deadline<\/strong> <strong>for Class I and Unclassified medical devices<\/strong>, instead of September 24, 2020. <br><\/p>\n\n\n\n<p>The UDI requirements will then enter into force <strong>four years later<\/strong> than originally planned. <br><\/p>\n\n\n\n<p>The postponement decision is partially justified by the fact that in this period, the COVID-19 emergency situation could make difficult the preparation of the UDI requirements, to the extent that medical devices manufacturers should be given more time.<\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/07\/USA-FDA-UDI-2022-1024x536.png\" alt=\"FDA postpones to September 24, 2022 the UDI for Class I and Unclassified\" class=\"wp-image-15025\"\/><figcaption>FDA postpones to September 24, 2022 the UDI for Class I and Unclassified<\/figcaption><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Class I and Unclassified medical devices: the deadline for UDI requirements<\/strong><\/h2>\n\n\n\n<p>The two-year delay concerns the following requirements: <strong>date format<\/strong>, <strong>UDI labelling<\/strong> and the submission of data to the Global Unique Device Identification (<strong>GUDID<\/strong>) database.<br>The requirements for the affixing of <strong>UDI Direct Marking<\/strong> will be activated from September 24, 2022 too.<\/p>\n\n\n\n<p>Extending the deadline for UDI requirements to September 24, 2022, FDA gives <strong>more time to Class I and Unclassified medical device manufacturers<\/strong>, having regard also to the complicated situation that the sector is going through due to the COVID-19 epidemic. <\/p>\n\n\n\n<p>It should be reminded that it is not the first case of postponement with regard to Class I and Unclassified devices. <br>Indeed, initially FDA had established September 24, 2018 as the date of compliance for most of Class I and Unclassified devices. However, at the beginning of the 2018, due to complex political issues and technical problems, FDA decided to delay the deadline by two years. <br>Today, near the deadline, came the news of the new postponement to 2022.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>FDA postpones to September 2022 the expiry of UDI requirements: what to do?<\/strong><\/h2>\n\n\n\n<p>Two years is the right time to face in peace the adaptation to UDI requirements and it is important to organise ourselves now to plan the necessary actions.<br>Thema carries out support and strategic-regulatory activities for medical device manufacturers with regard to the <a href=\"https:\/\/www.thema-med.com\/en\/medical-device-registration-in-the-u-s-a\/\">UDI process and FDA requirements.<\/a> Do not hesitate to contact us at the email address <a href=\"mailto:sales@thema-group.it\">sales@thema-group.it<\/a>. <br><strong>Our regulatory experts are ready to support your company.<\/strong><\/p>\n\n\n\n<p><em>Source: <\/em> <\/p>\n\n\n\n<p><a href=\"https:\/\/www.fda.gov\/media\/110564\/download\">https:\/\/www.fda.gov\/media\/110564\/download<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On July 1, 2020, FDA published the update of the \u201cUnique Device Identification: Policy Regarding Compliance Dates for Class I and  [&#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":[],"class_list":["post-15067","post","type-post","status-publish","format-standard","hentry","category-news-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA postpones to September 24, 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