{"id":22951,"date":"2022-08-10T17:15:28","date_gmt":"2022-08-10T15:15:28","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=22951"},"modified":"2022-08-11T09:12:16","modified_gmt":"2022-08-11T07:12:16","slug":"us-gudid-entry-deadline-extension-for-consumer-health-products","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2022\/08\/10\/us-gudid-entry-deadline-extension-for-consumer-health-products\/","title":{"rendered":"US: GUDID entry deadline extension for Consumer Health Products"},"content":{"rendered":"<p>Last July, 22 FDA published the guideline <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/unique-device-identification-policy-regarding-compliance-dates-class-i-and-unclassified-devices?utm_medium=email&amp;utm_source=govdelivery\"><em>Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices<\/em><\/a> which extends the GUDID database entry deadline for certain Class I and Unclassified over-the-counter devices.<\/p>\n<p>The subject of the document is precisely <strong><em>Consumer Health Products<\/em><\/strong>, i.e., devices sold directly over-the-counter (OTC) to the consumer or in online stores.<\/p>\n<p>The following devices are not considered <em>Consumer Health Products<\/em>:<\/p>\n<ul>\n<li>Class I Reserved Devices, i.e., devices that require a 510(k) procedure;<\/li>\n<li>Restricted Devices, devices for professional use or sold by prescription;<\/li>\n<li>Implantable Devices, placed and implanted in the human body for 30 days or longer;<\/li>\n<li>Life-supporting or life-sustaining devices;<\/li>\n<li>Devices distributed to health care facilities, intended for use only by professionals, if: a) Subject to reuse or reprocess; or b) Intended for wound care.<\/li>\n<\/ul>\n<p>However, not all <em>Consumer Health Products<\/em> are eligible for the extension but only those belonging to <strong>Class I or Unclassified<\/strong> and subject to mandatory <strong>UDI code<\/strong> on the label and\/or packaging.<\/p>\n<p>The deadline for the registration in the GUDID database of the aforementioned devices, former 21 CFR 830.300, is <strong>December 8, 2022<\/strong>, thus extending by 75 days the original deadline of <a href=\"https:\/\/www.thema-med.com\/en\/2020\/07\/20\/fda-postpones-to-september-24-2022-the-udi-for-class-i-and-unclassified\/\">September 24<\/a>, which, however, remains valid for the affixation of the UDI code in the label and\/or packaging.<\/p>\n<p><em>Source:<\/em> <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/unique-device-identification-policy-regarding-compliance-dates-class-i-and-unclassified-devices?utm_medium=email&amp;utm_source=govdelivery\"><em>Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices<\/em><\/a><\/p>\n<p>&nbsp;<\/p>\n<h3><strong>Do you need more support?<\/strong><\/h3>\n<p>&gt;&gt;&gt; Thema&#8217;s experts can provide the necessary strategic and operational assistance for the implementation of the <strong>UDI system<\/strong>, along with registration in the <strong>GUDID database<\/strong>, as requirements for device commercialization in the US market.<\/p>\n<p>&gt;&gt;&gt; Thema can support you in fulfilling all <a href=\"https:\/\/www.thema-med.com\/en\/medical-device-registration-in-the-u-s-a\/\">pre- and post-market requirements<\/a> required by 21 CFR and U.S. federal regulation, enabling smooth and efficient device entry and distribution.<\/p>\n<p>&gt;&gt;&gt; Appoint Thema as your <a href=\"https:\/\/www.thema-med.com\/en\/services\/local-representative-and-license-holder\/\">U.S.Agent<\/a> and <a href=\"https:\/\/www.thema-med.com\/en\/services\/local-representative-and-license-holder\/us-initial-importer-service\/\">U.S.Initial Importer<\/a>, key roles required by regulation in order to market your devices in full autonomy.<\/p>\n<p><a href=\"mailto:sales@thema-med.com\">Contact us<\/a> for information.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Last July, 22 FDA published the guideline Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":22938,"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-22951","post","type-post","status-publish","format-standard","has-post-thumbnail","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>US: GUDID entry deadline extension for Consumer Health Products<\/title>\n<meta name=\"description\" content=\"Last July, 22 FDA published the guideline Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified...\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, 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