{"id":4547,"date":"2021-05-13T11:39:00","date_gmt":"2021-05-13T11:39:00","guid":{"rendered":"https:\/\/www.vistaar.ai\/?p=4547"},"modified":"2025-12-09T10:25:50","modified_gmt":"2025-12-09T10:25:50","slug":"unique-device-identification-system","status":"publish","type":"post","link":"https:\/\/stage-websites.ddismart.com\/vistaar\/blog\/unique-device-identification-system\/","title":{"rendered":"Unique Device Identification System"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">The FDA\u2019s <a href=\"https:\/\/www.ddismart.com\/unique-device-identification-solutions\/\" style=\"color:#00bab9;\">Unique Device Identification (UDI) system<\/a> was established to ensure that medical devices distributed in the United States can be accurately identified from manufacturing through distribution and ultimately at the point of patient use. Once fully implemented, most device labels will display a UDI in both human\u2011readable and machine\u2011readable formats. This system strengthens patient safety, enhances post\u2011market surveillance, and supports ongoing medical device innovation.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">FDA Requirements for Medical Device Labelers<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Labelers must:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Place a UDI on device labels&nbsp;<\/li>\n\n\n\n<li>Submit device information to the <a href=\"https:\/\/www.ddismart.com\/unique-device-identification-solutions\/\" style=\"color:#00bab9;\">Global Unique Device Identification Database<\/a> (GUDID)&nbsp;<\/li>\n\n\n\n<li>Designate a Regulatory Contact responsible for UDI compliance&nbsp;<\/li>\n<\/ul>\n\n\n\n<p style=\"color:#000\">The Unique Device Identification System, commonly referred to as UDI, is a&nbsp;<a style=\"color:#00bab9\" href=\"https:\/\/www.fda.gov\/\" target=\"_blank\" rel=\"noreferrer noopener\">Food and Drug Administration (FDA)<\/a>&nbsp;rule that requires medical device labelers to mark medical packages and devices with a unique barcode. These labels aid supply chain and healthcare professionals in accurately identifying of medical devices during transit and use.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-22963acf31deaef1332fb8c56d9f1767 wp-block-paragraph\">The responsibility for UDI compliance falls largely on device labelers, who must include a unique device identifier on all non-exempt&nbsp;medical devices and packages. UDI barcodes are composed of two parts. The device identifier (DI) indicates the labeler and device model, while the production identifier (PI) may indicate batch number, serial number, manufacture date, or expiration date. The FDA&#8217;s final rule includes several exceptions and alternatives for certain devices, in order to minimize the cost of burden placed on labelers.&nbsp;<\/p>\n\n\n\n<p style=\"color:#000\">UDI labels must be applied to medical devices or stand-alone software that are deemed&nbsp;<a style=\"color:#00bab9\" href=\"https:\/\/www.fda.gov\/downloads\/MedicalDevices\/DeviceRegulationandGuidance\/UniqueDeviceIdentification\/UCM382463.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">life-sustaining, life-supporting, or implantable<\/a>. A UDI label must be applied permanently to the body of the device if it is designed to be used more than once.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-03c257f832204f2ecd2534b234cb5b08 wp-block-paragraph\">Class III medical devices must bear a UDI on the device itself if designed to be used more than once. The packaging and labels of all class II medical devices and class II stand-alone software must have UDI labels.&nbsp;<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-897744b990a6525c0681c6970c9aea22 wp-block-paragraph\">Class II devices that are intended to be used multiple times must have a UDI directly on the device. The packaging of class I medical devices, class I stand-alone software, and any medical devices that are not categorized in class I, II or III must have UDI labels.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-c1647976738650db9c956d18607e56fe wp-block-paragraph\">Class I medical devices must have a UDI on the body of the device if it will be used multiple times. This also applies to all medical devices that do not fall into class I, II or III.&nbsp;<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-116d15e9b86d6de93e3ecad353f8f544 wp-block-paragraph\">After receiving numerous requests for extensions, the FDA has extended the deadline for the direct marking of Class I and unclassified medical devices. UDI labeling and GUDID data submission for these devices still fall under the 2020 deadline.&nbsp;<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-a410a42657e0337fb631ab66838858f6 wp-block-paragraph\"><strong>Labelers and Medical Devices<\/strong><\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-04a4bbc12fd315a66c4e79930d4ddbfd wp-block-paragraph\">Device labelers must include a unique device identifier on all non-exempt medical devices and packages that are sold in the United States. Depending on the type of device, these UDI barcodes must be placed on the body of the medical device and\/or on the device packaging.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-26af274d3a3a1647c22617d1dc0633e0 wp-block-paragraph\">Labelers are most often the device manufacturers, but that is not always the case. The labeler could also be a repackager, reprocessor, relabeler, kit assembler, or specification developer. Whether or not a company is responsible for a UDI label depends on what type of medical device they process and where in the supply chain they handle it.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-d43f07c239fb02a74b9bf7dd0d0f837b wp-block-paragraph\">The device identifier (DI) should be placed on the device label in machine readable form. The production identifiers (PI) that are selected should be included, and both should be machine and human readable. The format for any human readable dates should be in the required format.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-b942ea34da3d68568ccc70295f88bf65 wp-block-paragraph\"><strong>Accredited Agency<\/strong><\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-75b7d6ebec8b63288fa57d4f2524b50e wp-block-paragraph\">The device manufacturer does not assign the device identifier (DI). Instead, it comes from an organization accredited by FDA. These organizations are called accredited agencies or, because they issue the DI, issuing agencies. To date, FDA has accredited three agencies: GS1, Health Industry Business Communications Council (HIBCC), and ICCBBA.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-2f24d97fc89d149215aefa65e6664886 wp-block-paragraph\">The accredited agency that is selected should be a supplier that provides a service. User should make sure that user have implemented the requirement, evaluation, and selection process in 21 CFR 820.50.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-e06e6bdf78b37023e869832f382e5328 wp-block-paragraph\"><strong>Components of UDI:<\/strong><\/p>\n\n\n\n<ol>\n<li style=\"color:#000\">Device Identifier<\/li>\n<li style=\"color:#000\">Lot number<\/li>\n<li style=\"color:#000\">Serial Number<\/li>\n<li style=\"color:#000\">Manufacture Date<\/li>\n<li style=\"color:#000\">Expiration Date<\/li>\n<\/ol>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-f6cc89e28b0d052fe863f591b665f08c wp-block-paragraph\"><strong>Comparison of UDI with globally accepted standards<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table style=\"color:#000\"><tbody style=\"color:#000\"><tr><td><strong>UDI<\/strong><\/td><td><strong>GTN<\/strong><\/td><td><strong>HIBCC<\/strong><\/td><td><strong>ICCBBA<\/strong><\/td><\/tr><tr><td>UDI:Device Identifier (UDI-DI)<\/td><td>GTN: Global Trade Item Number<\/td><td>HIBCC: HIBC-LIC (Labeler Identification Code)<\/td><td>ICCBBA: ISBT-28 PPIC (Processor Product Identification Code)<\/td><\/tr><tr><td>Production Identifier (UDI-PI)<\/td><td>Application Identifier (AI) becomes a part of PI<\/td><td>Flag Characters&nbsp; HIBC UDI format for PI<\/td><td>For PI (Product Identifier) one or more elements of ISBT 28 Data Structure can be used<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-12a77f2aff90df1abcb12b3e16a0ea7d wp-block-paragraph\"><strong>Compliance with UDI involves a three-pronged approach:<\/strong><\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-db8769a57e065a02865a05fc3ada8144 wp-block-paragraph\">1. Project planning: There needs to be well thought out project plan that includes analyzing product offerings that the company has and gathering certain information about each product. It has to have marketing authorization from FDA, the product code, and listing numbers, and then you have to determine (for each product) all the production information that you attach for each product. Once the information is gathered together, one of the issuing agencies that FDA authorizes must be selected. Then the barcodes that will go on the product needs to be designed so as to provide appropriate information.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-c489df5c42321c39e9996ddf634c3e66 wp-block-paragraph\">2. Process: Existing processes within the organization needs to be taken care and should determine what type of labeling, printing, acquisition and suppliers, and what kind of controls on labeling will be required; what printing or labeling mechanisms are being used in manufacturing lines now and do they need updates or changes, etc.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-3ed5b48f29a376a3a9f90a12ca88ffbb wp-block-paragraph\">3. Reporting into the GUIDID <a href=\"https:\/\/www.ddismart.com\/unique-device-identification-solutions\/\" style=\"color:#00bab9;\">[Global UDI Database]<\/a> itself: Determining the information that has to be downloaded into GUIDID. There\u2019s a lot of being done across the organization, involving regulatory, quality, manufacturing, operations, and the IT department, and management needs to give firm support to the projects.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-e043760fd6ecd7a39194da5c17a668fe wp-block-paragraph\">4. Each of these organizations has a required format for the UDI. The details can be seen in the document UDI formats by FDA-Accredited Issuing Agency.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-3f3043bf30ddbee0b097b3cd89e2e0b2 wp-block-paragraph\">5. GS1 &#8211; 14 numeric characters; HIBCC &#8211; 6 to 23 alphanumeric characters; ICCBBA &#8211; 18 alphanumeric characters<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-5cb2049c952eac2b197e82b3de88c451 wp-block-paragraph\">6. In addition to the data structure, the accredited agencies may allow (or restrict) the data carrier. Generally, the data carrier implements automatic identification and data capture (AIDC). The data carrier is the method used to present the machine readable information. Allowed data carriers include linear bar codes, 2D bar codes, QR codes, RFID chips, etc. FDA does not specify the data carrier; the device manufacturer decides based on what customers can read and what the accredited agency allows. However, if the customer cannot read it, there is little value in this approach. It appears that the vast majority of manufacturers will implement linear bar codes.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-a6fa60236a1fcd92c09772003f7d5e67 wp-block-paragraph\">7. The Date Format<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-5d397c462b3d59f71bde235edc0db102 wp-block-paragraph\">The rule requires that human readable dates conform to a standard format to avoid confusion and misleading users. The standard format, in most cases, uses year-month-day (e.g., 2013-09-30). The exception is the date of manufacture for electronic products that FDA regulates. In 21 CFR 1010.3(a)(2)(ii) the required date format is the month without abbreviation and the year as a four-digit number (e.g., Manufactured: September 2013).<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-a800b727c9efdc10c8106e8fb3d123e2 wp-block-paragraph\">8. One important point is that the AIDC may include dates using characters. For example, there are often printed characters under a linear bar code. These dates are part of the AIDC as specified by the issuing agency. FDA does not regulate how the AIDC communicates data; these dates do not have to be in the human readable date format<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-77f8a1c2be422fd03a362d06c5090bc6 wp-block-paragraph\"><strong>The Unique Device Identification (UDI) System will benefit healthcare providers, manufacturers, and individual consumers by enabling:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list has-black-color has-text-color has-link-color wp-elements-0c7ce28bf1a176e740ab54d7c25599d1\">\n<li>Faster discovery of flawed medical devices<\/li>\n\n\n\n<li>Faster recalls<\/li>\n\n\n\n<li>A reduction in medical errors<\/li>\n\n\n\n<li>A reduction in counterfeiting<\/li>\n\n\n\n<li>More informed patient treatment<\/li>\n\n\n\n<li>A better assessment of device performance<\/li>\n\n\n\n<li>Improved inventory management<\/li>\n\n\n\n<li>Doctors to spend more time with patients<\/li>\n\n\n\n<li>The creation of a world-wide medical device identification system<\/li>\n<\/ul>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-c9541f8d6c4e72be2cdd7a0b3bf2a0a8 wp-block-paragraph\"><strong>Faster Discovery of Flawed Medical Devices<\/strong><\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-e921369ef0ace02a3c5a359a0bc081d3 wp-block-paragraph\">When a defective medical device is discovered, it is reported to the Food and Drug Administration (FDA). The FDA receives hundreds of thousands of these reports every year and must determine which are valid, which single-device flaws are, and which constitute a pattern of defects that necessitate a recall.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-c371ba3257506626d61f3e029317f04b wp-block-paragraph\">The medical facilitates submitting these reports are often unsure of when they received the flawed medical device and from which supplier, let alone the manufacture date or batch number. This greatly hampers the FDA\u2019s ability to determine if a reported medical device flaw is a single occurrence or a concerning pattern.&nbsp;<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-51afa015225c5b22e3e8c4035bdb009f wp-block-paragraph\">When a flawed medical device is found, the UDI label will show exactly where the device came from, as well as its batch number and expiration date in some circumstances.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-403163b54b33975c5262b45508963c57 wp-block-paragraph\">Now when the FDA receives medical device reports, they can cross reference UDI numbers and swiftly identify patterns. In this way, the Unique Device Identification system greatly reduces the timeline between the first flawed device identification and the determination that a recall is necessary.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-e9b4e05ca3c7ebe70537edd676fdf316 wp-block-paragraph\">With UDI, Origen would be able to examine the flawed medical devices and track them back to the manufacturer to more specifically identify when the flaw occurred. If a medical device recall could be pinpointed to specific weeks rather than months or years, it would save massive amounts of time and money and reduce the number of functional medical devices that are thrown out.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-1f9db35794a1a47ff222db40779e7c22 wp-block-paragraph\"><strong><u>Reduction in Medical Errors<\/u><\/strong><\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-19986ad01eca546c720d6abddcfb3c03 wp-block-paragraph\">By providing specific information regarding device characteristics, the Unique Device Identification barcode makes it easy for healthcare professionals to accurately identify medical devices. This cuts down on time and prevents confusion regarding different medical device models.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-753d540d79c3a92834f66be74a673dba wp-block-paragraph\">Clear USI labeling also allows for an additional level of verification before a medical device is used or implanted in a patient. This extra authentication helps prevent mix-ups, which can have deadly consequences. In some cases, UDI will also ensure that expiration dates are clearly displayed on individual medical devices, instead of only being recorded on the box that the medical devices were shipped in.<\/p>\n\n\n<div style=\"color:#00bab9;font-size:16px\" class=\"taxonomy-post_tag has-link-color wp-elements-063c43e30005e18537946fce2c4d9b3a wp-block-post-terms has-text-color\"><span class=\"wp-block-post-terms__prefix\"><strong><mark style=\"background-color:#ffffff\" class=\"has-inline-color has-black-color\">Tags:<\/mark><\/strong> <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/fda-requires-medical-device-labelers\/\" rel=\"tag\">FDA requires medical device labelers<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/gudid\/\" rel=\"tag\">GUDID<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/medical-devices\/\" rel=\"tag\">Medical Devices<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/medical-devices-labeling\/\" rel=\"tag\">Medical Devices Labeling<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/udi\/\" rel=\"tag\">UDI<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/unique-device-identification-system\/\" rel=\"tag\">Unique Device Identification System<\/a><\/div>","protected":false},"excerpt":{"rendered":"<p>The FDA\u2019s Unique Device Identification (UDI) system was established to ensure that medical devices distributed in the United States can be accurately identified from manufacturing through distribution and ultimately at the point of patient use. Once fully implemented, most device labels will display a UDI in both human\u2011readable and machine\u2011readable formats. This system strengthens patient [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1877,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[645],"tags":[541,544,101,542,543,540],"class_list":["post-4547","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-device","tag-fda-requires-medical-device-labelers","tag-gudid","tag-medical-devices","tag-medical-devices-labeling","tag-udi","tag-unique-device-identification-system"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\r\n<title>Unique Device Identification System<\/title>\r\n<meta name=\"description\" content=\"The FDA established the unique device identification system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use.\" \/>\r\n<meta 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