{"id":539,"date":"2016-07-25T19:09:47","date_gmt":"2016-07-25T19:09:47","guid":{"rendered":"https:\/\/awrightpath.net\/?p=539"},"modified":"2019-06-05T19:16:02","modified_gmt":"2019-06-05T19:16:02","slug":"cdrh-industry-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\/cdrh-industry-fda-issues-draft-guidance-on-the-unique-device-identification-system-form-and-content-of-the-unique-device-identifier-udi\/","title":{"rendered":"CDRH Industry: FDA Issues Draft Guidance on the Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)"},"content":{"rendered":"\n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Today, the U.S. Food and Drug Administration released a draft guidance document, ?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This draft guidance is intended to assist both labelers and FDA-accredited IAs better ensure the UDIs developed under IA systems are in compliance with the UDI rule.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We welcome your comments regarding this draft guidance.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&nbsp;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>CDRH Industry: FDA Issues Draft Guidance on the Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI) - A Wright Path | Right Path. 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