U.S. FDA UDI Requirements & Compliance Resources

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.