{"id":537,"date":"2016-07-25T19:10:57","date_gmt":"2016-07-25T19:10:57","guid":{"rendered":"https:\/\/awrightpath.net\/?p=537"},"modified":"2019-06-05T19:12:41","modified_gmt":"2019-06-05T19:12:41","slug":"fda-issues-draft-guidance-on-the-unique-device-identification-system-form-and-content-of-the-unique-device-identifier-udi","status":"publish","type":"post","link":"https:\/\/awrightpath.net\/fda-issues-draft-guidance-on-the-unique-device-identification-system-form-and-content-of-the-unique-device-identifier-udi\/","title":{"rendered":"FDA Issues Draft Guidance on the Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)"},"content":{"rendered":"\n<p>Today, the U.S. Food and Drug Administration released a draft guidance document, ?<a href=\"http:\/\/www.fda.gov\/downloads\/MedicalDevices\/DeviceRegulationandGuidance\/GuidanceDocuments\/UCM512648.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)<\/a>.? &nbsp;The Unique Device Identification System Rule (<a href=\"https:\/\/www.federalregister.gov\/articles\/2013\/09\/24\/2013-23059\/unique-device-identification-system\" target=\"_blank\" rel=\"noreferrer noopener\">UDI Rule<\/a>) requires the label and device packages of most medical devices to bear a unique device identifier (UDI) in both easily readable plain-text and automatic identification and data capture (AIDC) technology forms.&nbsp;UDIs must be issued under a system operated by&nbsp;<a href=\"http:\/\/www.fda.gov\/MedicalDevices\/DeviceRegulationandGuidance\/UniqueDeviceIdentification\/UDIIssuingAgencies\/default.htm\" target=\"_blank\" rel=\"noreferrer noopener\">FDA-accredited issuing agencies<\/a>&nbsp;(IAs).<\/p>\n\n\n\n<p>This draft guidance is intended to assist both labelers and FDA-accredited IAs better ensure the UDIs developed under IA systems are in compliance with the UDI rule. &nbsp;It includes clarification on:<\/p>\n\n\n\n<ul><li>Two forms of a UDI;<\/li><li>Content of the UDI (including data delimiters that identify specific data elements within the UDI); and<\/li><li>Order of data in a UDI and UDI carrier (the means to convey the UDI and any non-UDI elements in easily readable plain-text and AIDC forms).<\/li><\/ul>\n\n\n\n<p>We welcome your comments regarding this draft guidance. The comment period closes in 60 days.<\/p>\n\n\n\n<p>For more information about the Unique Device Identification System, please visit the&nbsp;<a href=\"http:\/\/www.fda.gov\/MedicalDevices\/DeviceRegulationandGuidance\/UniqueDeviceIdentification\/default.htm\" target=\"_blank\" rel=\"noreferrer noopener\">FDA?s UDI webpage<\/a>.<\/p>\n\n\n\n<p>If you have any questions, please contact the&nbsp;<a href=\"http:\/\/www.fda.gov\/MedicalDevices\/DeviceRegulationandGuidance\/UniqueDeviceIdentification\/ucm368904.htm\" target=\"_blank\" rel=\"noreferrer noopener\">FDA UDI Help Desk<\/a>.<\/p>\n\n\n\n<p>Thank you,<br>Food and Drug Administration<br>Center for Devices and Radiological Health<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Today, the U.S. Food and Drug Administration released a draft guidance document, ?Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI).? &nbsp;The Unique Device Identification System Rule (UDI Rule) requires the label and device packages of most medical devices to bear a unique device identifier (UDI) in both easily readable plain-text [&hellip;]<\/p>\n","protected":false},"author":10,"featured_media":335,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[8,9],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v20.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA Issues Draft Guidance on the Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI) - A Wright Path | Right Path. Right Now!<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/awrightpath.net\/fda-issues-draft-guidance-on-the-unique-device-identification-system-form-and-content-of-the-unique-device-identifier-udi\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Issues Draft Guidance on the Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI) - A Wright Path | Right Path. Right Now!\" \/>\n<meta property=\"og:description\" content=\"\" \/>\n<meta property=\"og:url\" content=\"https:\/\/awrightpath.net\/fda-issues-draft-guidance-on-the-unique-device-identification-system-form-and-content-of-the-unique-device-identifier-udi\/\" \/>\n<meta property=\"og:site_name\" content=\"A Wright Path | Right Path. Right Now!\" \/>\n<meta property=\"article:published_time\" content=\"2016-07-25T19:10:57+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2019-06-05T19:12:41+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/awrightpath.net\/wp-content\/uploads\/2019\/05\/check-up-dentist-doctors-1170979-e1559765594664.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1920\" \/>\n\t<meta property=\"og:image:height\" content=\"1280\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"matt@madebywink.com\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"matt@madebywink.com\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/awrightpath.net\/fda-issues-draft-guidance-on-the-unique-device-identification-system-form-and-content-of-the-unique-device-identifier-udi\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/awrightpath.net\/fda-issues-draft-guidance-on-the-unique-device-identification-system-form-and-content-of-the-unique-device-identifier-udi\/\"},\"author\":{\"name\":\"matt@madebywink.com\",\"@id\":\"https:\/\/awrightpath.net\/#\/schema\/person\/801f9e2ca8057bb3c09ebf8ffb37b604\"},\"headline\":\"FDA Issues Draft Guidance on the Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)\",\"datePublished\":\"2016-07-25T19:10:57+00:00\",\"dateModified\":\"2019-06-05T19:12:41+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/awrightpath.net\/fda-issues-draft-guidance-on-the-unique-device-identification-system-form-and-content-of-the-unique-device-identifier-udi\/\"},\"wordCount\":0,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\/\/awrightpath.net\/#organization\"},\"articleSection\":[\"News\",\"US FDA\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\/\/awrightpath.net\/fda-issues-draft-guidance-on-the-unique-device-identification-system-form-and-content-of-the-unique-device-identifier-udi\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/awrightpath.net\/fda-issues-draft-guidance-on-the-unique-device-identification-system-form-and-content-of-the-unique-device-identifier-udi\/\",\"url\":\"https:\/\/awrightpath.net\/fda-issues-draft-guidance-on-the-unique-device-identification-system-form-and-content-of-the-unique-device-identifier-udi\/\",\"name\":\"FDA Issues Draft Guidance on the Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI) - A Wright Path | Right Path. Right Now!\",\"isPartOf\":{\"@id\":\"https:\/\/awrightpath.net\/#website\"},\"datePublished\":\"2016-07-25T19:10:57+00:00\",\"dateModified\":\"2019-06-05T19:12:41+00:00\",\"breadcrumb\":{\"@id\":\"https:\/\/awrightpath.net\/fda-issues-draft-guidance-on-the-unique-device-identification-system-form-and-content-of-the-unique-device-identifier-udi\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/awrightpath.net\/fda-issues-draft-guidance-on-the-unique-device-identification-system-form-and-content-of-the-unique-device-identifier-udi\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/awrightpath.net\/fda-issues-draft-guidance-on-the-unique-device-identification-system-form-and-content-of-the-unique-device-identifier-udi\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/awrightpath.net\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"FDA Issues Draft Guidance on the Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/awrightpath.net\/#website\",\"url\":\"https:\/\/awrightpath.net\/\",\"name\":\"A Wright Path | Right Path. Right Now!\",\"description\":\"We are trusted in regulatory compliance to help navigating your path to FDA\",\"publisher\":{\"@id\":\"https:\/\/awrightpath.net\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/awrightpath.net\/?s={search_term_string}\"},\"query-input\":\"required name=search_term_string\"}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/awrightpath.net\/#organization\",\"name\":\"A Wright Path | Right Path. Right Now!\",\"url\":\"https:\/\/awrightpath.net\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/awrightpath.net\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/awrightpath.net\/wp-content\/uploads\/2021\/02\/cropped-AWP-Logo-TM.png\",\"contentUrl\":\"https:\/\/awrightpath.net\/wp-content\/uploads\/2021\/02\/cropped-AWP-Logo-TM.png\",\"width\":462,\"height\":127,\"caption\":\"A Wright Path | Right Path. Right Now!\"},\"image\":{\"@id\":\"https:\/\/awrightpath.net\/#\/schema\/logo\/image\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\/\/awrightpath.net\/#\/schema\/person\/801f9e2ca8057bb3c09ebf8ffb37b604\",\"name\":\"matt@madebywink.com\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/awrightpath.net\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/b93b7673e463f96ff38fe65b5ad969a9?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/b93b7673e463f96ff38fe65b5ad969a9?s=96&d=mm&r=g\",\"caption\":\"matt@madebywink.com\"},\"url\":\"https:\/\/awrightpath.net\/author\/mattmadebywink-com\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"FDA Issues Draft Guidance on the Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI) - A Wright Path | Right Path. Right Now!","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/awrightpath.net\/fda-issues-draft-guidance-on-the-unique-device-identification-system-form-and-content-of-the-unique-device-identifier-udi\/","og_locale":"en_US","og_type":"article","og_title":"FDA Issues Draft Guidance on the Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI) - A Wright Path | Right Path. Right Now!","og_description":"Today, the U.S. Food and Drug Administration released a draft guidance document, ?Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI).? &nbsp;The Unique Device Identification System Rule (UDI Rule) requires the label and device packages of most medical devices to bear a unique device identifier (UDI) in both easily readable plain-text [&hellip;]","og_url":"https:\/\/awrightpath.net\/fda-issues-draft-guidance-on-the-unique-device-identification-system-form-and-content-of-the-unique-device-identifier-udi\/","og_site_name":"A Wright Path | Right Path. Right Now!","article_published_time":"2016-07-25T19:10:57+00:00","article_modified_time":"2019-06-05T19:12:41+00:00","og_image":[{"width":1920,"height":1280,"url":"https:\/\/awrightpath.net\/wp-content\/uploads\/2019\/05\/check-up-dentist-doctors-1170979-e1559765594664.jpg","type":"image\/jpeg"}],"author":"matt@madebywink.com","twitter_card":"summary_large_image","twitter_misc":{"Written by":"matt@madebywink.com","Est. reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/awrightpath.net\/fda-issues-draft-guidance-on-the-unique-device-identification-system-form-and-content-of-the-unique-device-identifier-udi\/#article","isPartOf":{"@id":"https:\/\/awrightpath.net\/fda-issues-draft-guidance-on-the-unique-device-identification-system-form-and-content-of-the-unique-device-identifier-udi\/"},"author":{"name":"matt@madebywink.com","@id":"https:\/\/awrightpath.net\/#\/schema\/person\/801f9e2ca8057bb3c09ebf8ffb37b604"},"headline":"FDA Issues Draft Guidance on the Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)","datePublished":"2016-07-25T19:10:57+00:00","dateModified":"2019-06-05T19:12:41+00:00","mainEntityOfPage":{"@id":"https:\/\/awrightpath.net\/fda-issues-draft-guidance-on-the-unique-device-identification-system-form-and-content-of-the-unique-device-identifier-udi\/"},"wordCount":0,"commentCount":0,"publisher":{"@id":"https:\/\/awrightpath.net\/#organization"},"articleSection":["News","US FDA"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/awrightpath.net\/fda-issues-draft-guidance-on-the-unique-device-identification-system-form-and-content-of-the-unique-device-identifier-udi\/#respond"]}]},{"@type":"WebPage","@id":"https:\/\/awrightpath.net\/fda-issues-draft-guidance-on-the-unique-device-identification-system-form-and-content-of-the-unique-device-identifier-udi\/","url":"https:\/\/awrightpath.net\/fda-issues-draft-guidance-on-the-unique-device-identification-system-form-and-content-of-the-unique-device-identifier-udi\/","name":"FDA Issues Draft Guidance on the Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI) - A Wright Path | Right Path. Right Now!","isPartOf":{"@id":"https:\/\/awrightpath.net\/#website"},"datePublished":"2016-07-25T19:10:57+00:00","dateModified":"2019-06-05T19:12:41+00:00","breadcrumb":{"@id":"https:\/\/awrightpath.net\/fda-issues-draft-guidance-on-the-unique-device-identification-system-form-and-content-of-the-unique-device-identifier-udi\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/awrightpath.net\/fda-issues-draft-guidance-on-the-unique-device-identification-system-form-and-content-of-the-unique-device-identifier-udi\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/awrightpath.net\/fda-issues-draft-guidance-on-the-unique-device-identification-system-form-and-content-of-the-unique-device-identifier-udi\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/awrightpath.net\/"},{"@type":"ListItem","position":2,"name":"FDA Issues Draft Guidance on the Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)"}]},{"@type":"WebSite","@id":"https:\/\/awrightpath.net\/#website","url":"https:\/\/awrightpath.net\/","name":"A Wright Path | Right Path. Right Now!","description":"We are trusted in regulatory compliance to help navigating your path to FDA","publisher":{"@id":"https:\/\/awrightpath.net\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/awrightpath.net\/?s={search_term_string}"},"query-input":"required name=search_term_string"}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/awrightpath.net\/#organization","name":"A Wright Path | Right Path. Right Now!","url":"https:\/\/awrightpath.net\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/awrightpath.net\/#\/schema\/logo\/image\/","url":"https:\/\/awrightpath.net\/wp-content\/uploads\/2021\/02\/cropped-AWP-Logo-TM.png","contentUrl":"https:\/\/awrightpath.net\/wp-content\/uploads\/2021\/02\/cropped-AWP-Logo-TM.png","width":462,"height":127,"caption":"A Wright Path | Right Path. Right Now!"},"image":{"@id":"https:\/\/awrightpath.net\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/awrightpath.net\/#\/schema\/person\/801f9e2ca8057bb3c09ebf8ffb37b604","name":"matt@madebywink.com","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/awrightpath.net\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/b93b7673e463f96ff38fe65b5ad969a9?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/b93b7673e463f96ff38fe65b5ad969a9?s=96&d=mm&r=g","caption":"matt@madebywink.com"},"url":"https:\/\/awrightpath.net\/author\/mattmadebywink-com\/"}]}},"_links":{"self":[{"href":"https:\/\/awrightpath.net\/wp-json\/wp\/v2\/posts\/537"}],"collection":[{"href":"https:\/\/awrightpath.net\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/awrightpath.net\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/awrightpath.net\/wp-json\/wp\/v2\/users\/10"}],"replies":[{"embeddable":true,"href":"https:\/\/awrightpath.net\/wp-json\/wp\/v2\/comments?post=537"}],"version-history":[{"count":1,"href":"https:\/\/awrightpath.net\/wp-json\/wp\/v2\/posts\/537\/revisions"}],"predecessor-version":[{"id":538,"href":"https:\/\/awrightpath.net\/wp-json\/wp\/v2\/posts\/537\/revisions\/538"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/awrightpath.net\/wp-json\/wp\/v2\/media\/335"}],"wp:attachment":[{"href":"https:\/\/awrightpath.net\/wp-json\/wp\/v2\/media?parent=537"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/awrightpath.net\/wp-json\/wp\/v2\/categories?post=537"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/awrightpath.net\/wp-json\/wp\/v2\/tags?post=537"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}