--- title: What You Need to Know About a UDI Implementation Strategy description: By 2020, all medical devices must have a UDI. Is your company UDI compliant? If not, here's how to create your UDI implementation strategy. image: https://blog.southeastcomputers.com/hubfs/1126687-globe-isolated-on-pure-white-background-28kpf7s-4.jpg --- **[Sage X3](https://www.southeastcomputers.com/sage-enterprise-management-infomation) | **[Sage 100cloud](https://www.southeastcomputers.com/sage-100cloud-information) | [Acumatica](https://www.southeastcomputers.com/acumatica-information) | [LATAM Fiscal Requirements](https://www.southeastcomputers.com/latam-fiscal-requirements-localize-sagex3-sage-500) | [Contact Us |](https://interact.southeastcomputers.com/contact-us) [ 888-773-2161](tel:888-773-2161)**** [![logo-naw-southeast-website](https://blog.southeastcomputers.com/hs-fs/hubfs/logo-naw-southeast-website.png?width=578&height=160&name=logo-naw-southeast-website.png "logo-naw-southeast-website")](https://www.southeastcomputers.com) This is a search field with an auto-suggest feature attached. - There are no suggestions because the search field is empty. ![Florida Miami Image](https://blog.southeastcomputers.com/hs-fs/hubfs/Banners/Florida-Miami.jpg?width=2880&name=Florida-Miami.jpg "Florida Miami Image") # Blog Want our new blog posts delivered right to your inbox?  February 29, 2016 # What You Need to Know About a UDI Implementation Strategy - [Tweet](https://twitter.com/share) ![authorIcon](http://www.sparkreaction.com/hubfs/Oceania%20Theme%202016/Images/authorIcon.png) By [Abe Farhan](https://blog.southeastcomputers.com/author/abe-farhan) ![topicIcon](http://www.sparkreaction.com/hubfs/Oceania%20Theme%202016/Images/topicIcon.png) [UDI](https://blog.southeastcomputers.com/topic/udi), [All](https://blog.southeastcomputers.com/topic/all) [![What You Need to Know About a UDI Implementation Strategy](https://blog.southeastcomputers.com/hubfs/1126687-globe-isolated-on-pure-white-background-28kpf7s-4.jpg) ](https://blog.southeastcomputers.com/what-you-need-to-know-about-a-udi-implementation-strategy) In 2007, the government passed the Food and Drug Administration Amendments Act (FDAAA). This act required the Food and Drug Administration (FDA) to establish a unique device identification provision for the purpose of increasing patient safety by improving the [handling of medical device information](https://www.southeastcomputers.com/medical-device-software). In 2013, the FDA implemented the *Unique Device Identification (UDI) System*. In this system, all medical devices distributed in the United States must be registered and must include a [UDI](https://interact.southeastcomputers.com/udi-ebook) – a numeric and/or alphanumeric code that identifies the device, its model type, and any current production information.  If you have not thought about your [UDI implementation](https://interact.southeastcomputers.com/udi-ebook) strategy, now is the time, as, by 2020, all medical devices must have a UDI. **Why UDI with Southeast Computer Solutions? Hear from Abraham Farhan. ** ****   The device identification system provides manufacturers and distributors with a universal set of standards to manage devices, which eliminates the duplicate codes that result in poor quality standards and the inability to track a device in the event of a recall.   In 2015, the FDA required medical device labelers to register UDIs for implantable, life-supporting, and life-sustaining medical devices. This is an important step toward increasing the traceability, transparency, and accuracy across the global healthcare supply chain.   **The new legislation will also offer benefits such as:** ## Enhanced Reporting Accuracy Because UDIs make devices easily identifiable and trackable, manufacturers can find and review product information more quickly and accurately during adverse events like recalls. As a result, such issues are solved much more quickly and efficiently. ## Reduction of Medical Related Errors Because UDIs enable healthcare professionals to quickly and precisely identify devices and obtain important data/device characteristics, the quality of care provided will improve while negative medical related issues will be reduced. ## Global Standardization With global standardization, manufacturers, distributors, and healthcare facilities can effectively manage medical device recalls and their potential consequences. This provides a foundation for a globally secure distribution chain that addresses counterfeiting. In addition to assisting with device data management, UDIs help resolve widespread labeling challenges.   **Using the Device Identification System, manufacturers must: ** - Create a globally unique Device Identification (DI) code. - Create and maintain descriptive attributes for each device. - Submit the DI and required descriptive attributes to the FDA's Global UDI Database (GUDID). - Include both Device Identifier and Production Identifier (lot, bаtсh, ѕеriаl) information on the product, either etching it onto the device or affixing a label to it. This change is significant – and mandatory – for the worldwide medical field and all medical devices must contain a UDI by 2020.    Are you overwhelmed? Do you have questions? Do you need help? [Contact](https://www.southeastcomputers.com/contact-us.php) Southeast Computer Solutions today. [![UDI eBook](https://no-cache.hubspot.com/cta/default/418036/a7e53c79-fc8d-487d-a289-7b4870b25f4d.png)](https://cta-redirect.hubspot.com/cta/redirect/418036/a7e53c79-fc8d-487d-a289-7b4870b25f4d) ***About Southeast Computer Solutions*** *Southeast Computer Solutions is based in Miami, Florida, and has additional operations in Mexico. For over 30 years, we have positively impacted the success of small and mid-sized businesses with effective business management implementations that improve our clients’ operations. We listen, we are accessible, and we care. Learn more by [visiting our website](https://www.southeastcomputers.com/) or calling 305-556-4697.*   *Need [Sage Software Support](https://www.southeastcomputers.com/software-support)? 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[NEXT POST **](https://blog.southeastcomputers.com/managing-integrated-production-controls-while-supporting-effective-capa-failure-investigations) ### Related posts [Read More](https://blog.southeastcomputers.com/erp-solutions-for-pharmaceutical-manufacturers) ### [What You Need to Know About a UDI Implementation Strategy](https://blog.southeastcomputers.com/erp-solutions-for-pharmaceutical-manufacturers) By [**Abe Farhan**](https://blog.southeastcomputers.com/author/abe-farhan) August 3, 2016 There are several ERP systems on the market designed to address the specific challenges facing pharmaceutical manufacturers. When you're.. ![topicIcon](http://www.sparkreaction.com/hubfs/Oceania%20Theme%202016/Images/topicIcon.png) [UDI](https://blog.southeastcomputers.com/topic/udi) [Read More](https://blog.southeastcomputers.com/6-ways-sage-x3-can-help-your-udi-implementation) ### [What You Need to Know About a UDI Implementation Strategy](https://blog.southeastcomputers.com/6-ways-sage-x3-can-help-your-udi-implementation) By [**Abe Farhan**](https://blog.southeastcomputers.com/author/abe-farhan) March 15, 2016 To remain FDA compliant, all medical devices must have labels that contain a [unique device identification (UDI)](https://interact.southeastcomputers.com/establishing-a-udi-system) – a number that makes.. ![topicIcon](http://www.sparkreaction.com/hubfs/Oceania%20Theme%202016/Images/topicIcon.png) [UDI](https://blog.southeastcomputers.com/topic/udi) [Read More](https://blog.southeastcomputers.com/5-things-to-consider-when-defining-your-udi-strategy) ### [What You Need to Know About a UDI Implementation Strategy](https://blog.southeastcomputers.com/5-things-to-consider-when-defining-your-udi-strategy) By [**Abe Farhan**](https://blog.southeastcomputers.com/author/abe-farhan) March 8, 2016 The FDA has passed legislation requiring all medical devices to have a unique device identification (UDI) number to make them.. ![topicIcon](http://www.sparkreaction.com/hubfs/Oceania%20Theme%202016/Images/topicIcon.png) [UDI](https://blog.southeastcomputers.com/topic/udi) ### Search  --- ### Recent Posts ### Posts by Topic - 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