How Can GS1 Standards Help Your Company Meet FDA UDI Requirements?
FDA Unique Device Identification Rule
The FDA UDI rule on the establishment of a Unique Device Identification System requires most medical devices distributed in the U.S. to carry a Unique Device Identifier (UDI). This system, comprised of the UDI code, application of the UDI to device labeling and packaging, and a related database, is designed to provide a standardized way to identify devices across all information sources and systems, including electronic health records and devices registries.
Components of the FDA UDI System
The proposed effective dates for UDI requirements are based on risk class after publication of final rule:
Are you a healthcare manufacturer that is new to GS1 Standards? Learn how GS1 Standards can enable you to uniquely identify your products.
Are you already using GS1 Standards for production identification and marking? Access UDI tools and resources.
GS1 US on UDI
Why Should You Use GS1 Standards for FDA UDI?