--- title: Understanding UDI - USA --- [![2020_ReedTech_logo_fullColor-2](https://go.reedtech.com/hs-fs/hubfs/LS-logo%20files/2020_ReedTech_logo_fullColor-2.png?width=961&height=233&name=2020_ReedTech_logo_fullColor-2.png "2020_ReedTech_logo_fullColor-2")](https://www.reedtech.com/) ##### UNDERSTANDING UDI ![](https://go.reedtech.com/hubfs/GettyImages-1390650720.jpg) # Understanding UDI Series # US FDA & UDI FUNDAMENTALS The Global Unique Device Identification Database, also known as **GUDID** is governed by US FDA. Since its origins in 2013, the goal of GUDID is to strengthen public health by enforcing standards to ensure safety, security and reliability. Medical devices that are marketed in the US have a regulatory obligation to submit specific product data to GUDID for compliance. FDA has published final guidance for Class I, unclassified devices, Class II and Class III. Specific scenarios apply per device category. Learn more in the *‘Understanding UDI Series*’ about the regulations, scenarios and data elements required. ![USA-UDI-Consulting](https://go.reedtech.com/hs-fs/hubfs/USA-UDI-Consulting.png?width=750&name=USA-UDI-Consulting.png "USA-UDI-Consulting") --- ## Slides and PDF [US FDA Data Elements](https://go.reedtech.com/hubfs/~RT%20-%20LS%20-%20Life%20Sciences%20Files/RT%20-%20LS%20-%20Med%20Device/RT%20-%20LS%20-%20Med%20Device%20-%20Slides/RT%20-%20LS%20-%20SSMD%20UDI%20Data%20Elements%20Slides/RT%20-%20LS%20-%20SSMD%20US%20FDA%20UDI%20Data%20Elements-SLIDES.pdf) [![](https://www.reedtech.com/wp-content/uploads/2023/04/Slide-US-FDA-UDI.jpg "Slide-US-FDA-UDI")](https://go.reedtech.com/hubfs/~RT%20-%20LS%20-%20Life%20Sciences%20Files/RT%20-%20LS%20-%20Med%20Device/RT%20-%20LS%20-%20Med%20Device%20-%20Slides/RT%20-%20LS%20-%20SSMD%20UDI%20Data%20Elements%20Slides/RT%20-%20LS%20-%20SSMD%20US%20FDA%20UDI%20Data%20Elements-SLIDES.pdf) [US FDA History & Device Classes](https://go.reedtech.com/hubfs/~RT%20-%20LS%20-%20Life%20Sciences%20Files/RT%20-%20LS%20-%20Med%20Device/RT%20-%20LS%20-%20Med%20Device%20-%20Slides/RT%20-%20LS%20-%20SSMD%20US%20FDA%20History%20and%20Classes.pdf) [![US FDA History Title](https://go.reedtech.com/hs-fs/hubfs/Imported%20sitepage%20images/RT-LS-SSMD-US-FDA-History-Title-IMG-980x552.jpg?width=500&height=282&name=RT-LS-SSMD-US-FDA-History-Title-IMG-980x552.jpg)](https://go.reedtech.com/hubfs/~RT%20-%20LS%20-%20Life%20Sciences%20Files/RT%20-%20LS%20-%20Med%20Device/RT%20-%20LS%20-%20Med%20Device%20-%20Slides/RT%20-%20LS%20-%20SSMD%20US%20FDA%20History%20and%20Classes.pdf) [UDI: A Guide to Device Identifiers](https://go.reedtech.com/hubfs/~RT%20-%20LS%20-%20Life%20Sciences%20Files/RT%20-%20LS%20-%20Med%20Device/RT%20-%20LS%20-%20Med%20Device%20-%20Datasheets/RT%20-%20LS%20-%20202207%20-%20Med%20Device%20-%20UDI%20Device%20Identifier%20Guide%20-%20WP.pdf) [![UDI - A Guide to Device Identifiers](https://go.reedtech.com/hs-fs/hubfs/UDI%20-%20A%20Guide%20to%20Device%20Identifiers.png?width=450&height=231&name=UDI%20-%20A%20Guide%20to%20Device%20Identifiers.png)](https://go.reedtech.com/hubfs/~RT%20-%20LS%20-%20Life%20Sciences%20Files/RT%20-%20LS%20-%20Med%20Device/RT%20-%20LS%20-%20Med%20Device%20-%20Datasheets/RT%20-%20LS%20-%20202207%20-%20Med%20Device%20-%20UDI%20Device%20Identifier%20Guide%20-%20WP.pdf) [The Ultimate Guide to UDI](https://go.reedtech.com/hubfs/~RT%20-%20LS%20-%20Life%20Sciences%20Files/RT%20-%20LS%20-%20Med%20Device/RT%20-%20LS%20-%20Med%20Device%20-%20Datasheets/RT%20-%20LS%20-%20SSMD%20Ultimate-Guide-to-UDI.pdf) [![UDI - Ultimate guide for UDI](https://go.reedtech.com/hs-fs/hubfs/UDI%20-%20Ultimate%20guide%20for%20UDI.png?width=450&height=229&name=UDI%20-%20Ultimate%20guide%20for%20UDI.png)](https://go.reedtech.com/hubfs/~RT%20-%20LS%20-%20Life%20Sciences%20Files/RT%20-%20LS%20-%20Med%20Device/RT%20-%20LS%20-%20Med%20Device%20-%20Datasheets/RT%20-%20LS%20-%20SSMD%20Ultimate-Guide-to-UDI.pdf)   --- ## Video Tutorials [Unique Device Identification (UDI) for Medical Devices](https://youtu.be/KoUmTaGlUWU) [US FDA UDI Class I Status, Maintenance, Enforcements](https://youtu.be/k0OeK5TaozA) What to know about GUDID Class I UDI Submissions & Exceptions Did you get a letter from FDA about missing devices in GUDID? GMDN Obsolete Codes in GUDID [ Take the Quiz ](https://www.surveymonkey.com/r/UDIQUIZ) ## Understanding UDI (Click on the Health Authority map to see the assets) - [![USA UDI Consulting](https://go.reedtech.com/hs-fs/hubfs/USA-UDI-Consulting-2.png?width=750&height=750&name=USA-UDI-Consulting-2.png) **USA + UDI Fundamentals** ](https://go.reedtech.com/understanding-udi-usa) - [![European Union UDI](https://go.reedtech.com/hs-fs/hubfs/EUDAMED-UDI-Consulting-1.png?width=750&height=750&name=EUDAMED-UDI-Consulting-1.png) **EUROPEAN UNION** ](https://go.reedtech.com/understanding-udi-europeanunion) - [![China UDI](https://go.reedtech.com/hs-fs/hubfs/China-UDI-Consulting-2.png?width=750&height=750&name=China-UDI-Consulting-2.png) **CHINA** ](https://go.reedtech.com/understanding-udi-china) - [![South Korea UDI](https://go.reedtech.com/hs-fs/hubfs/Korea-UDI-Consulting-2.png?width=750&height=750&name=Korea-UDI-Consulting-2.png) **SOUTH KOREA** ](https://go.reedtech.com/understanding-udi-southkorea) - [![Australia UDI](https://go.reedtech.com/hs-fs/hubfs/Australia%20-%20UDI-3.png?width=750&height=750&name=Australia%20-%20UDI-3.png) **AUSTRALIA** ](https://go.reedtech.com/understanding-udi-australia) ---   [![RT - LS - 20201208 - General - Branding - Logo Color 961x233 - IMG](https://go.reedtech.com/hs-fs/hubfs/~RT%20-%20LS%20-%20Life%20Sciences%20Files/RT%20-%20LS%20-%20General/RT%20-%20LS%20-%20General%20-%20Branding/RT%20-%20LS%20-%20Branding%20-%20Logos/RT%20-%20LS%20-%2020201208%20-%20General%20-%20Branding%20-%20Logo%20Color%20961x233%20-%20IMG.png?width=961&height=233&name=RT%20-%20LS%20-%2020201208%20-%20General%20-%20Branding%20-%20Logo%20Color%20961x233%20-%20IMG.png "RT - LS - 20201208 - General - Branding - Logo Color 961x233 - IMG")](https://www.reedtech.com/) Copyright © 2024 LexisNexis. 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