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Understanding UDI Series
Gain answers to your questions about Unique Device Identification (UDI). Book time with a UDI expert for in-depth Q&A plus access to a library of tutorials and reference materials
US FDA & UDI FUNDAMENTALS
The United States established its Unique Device Identification (UDI) framework under the US Food and Drug Administration (FDA) to strengthen device traceability, public health protection, and supply chain transparency. The system is supported by the Global Unique Device Identification Database (GUDID), which requires manufacturers marketing devices in the US to submit and maintain standardized product data.
Implementation has progressed across Class I, unclassified, Class II, and Class III devices in accordance with FDA final guidance and regulatory timelines. Manufacturers placing devices on the US market must ensure accurate UDI labeling and ongoing GUDID data submissions to remain compliant with FDA requirements.
As part of the Understanding UDI Series, we examine FDA regulations, GUDID submission scenarios, and the data elements required to maintain ongoing US FDA UDI compliance.
LexisNexis Life Sciences simplifies that complexity. We support manufacturers across the entire product lifecycle — from initial market entry and UDI data preparation to ongoing updates, change management, and post-market compliance. Our global regulatory expertise and technology-driven solutions help ensure your device data stays accurate, synchronized, and inspection-ready, so you can focus on innovation while we help safeguard compliance.
Slides and PDF
Video Tutorials
Related Resources
The State of Global Regulatory Compliance 2026
Global authorities are accelerating UDI expansion and modernizing submission frameworks worldwide. Life sciences organizations must strengthen data governance while adapting to evolving regulatory expectations. Explore the key trends shaping compliance in 2026.
2026 Is a Global UDI Turning Point
Major UDI requirements are taking effect across the EU, Australia, and Switzerland. Ensure your compliance strategy is aligned before deadlines arrive.
FDA Updates Guidance on GUDID and GMDN Codes: What You Need to Know
The FDA has introduced significant updates impacting the medical device industry, specifically targeting Global Medical Device Nomenclature (GMDN) Codes compliance in the Global Unique Device Identification Database (GUDID).
Understanding UDI
Unique Device Identification (UDI) requirements vary by country and regulatory authority. Select a health authority below to access jurisdiction-specific guidance and resources.
USA
EUROPEAN UNION
CHINA
SOUTH KOREA
AUSTRALIA
SWITZERLAND
Need Guidance on UDI Compliance?
Understanding UDI obligations across global health authorities can be complex. Whether you are preparing for initial submission, managing product data updates, or aligning compliance across multiple markets, our regulatory experts provide practical guidance tailored to your organization’s needs.
