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Unique Device Identification (UDI)

Complying with the US Food and Drug Administration (US FDA)

Being able to identify, track and trace medical devices at a global level is important for patient safety.

For this reason, the US Food and Drug Administration (US FDA) now requires all medical devices sold in the US to carry a bar coded Unique Device Identifier (UDI), and all  information about each device be held in an US FDA managed database.

The rule applied to some products as early as September 2014 with other products being phased in over the next few years. This means that any UK medical device manufacturer wanting to trade with the US healthcare market must comply with this regulation. Similar regulations are expected to follow globally, but adapting to these changes is easy through GS1 Standards.

GS1 has been accredited by the FDA as an issuing agency for UDIs and our standards for identification and barcoding conform to all FDA UDI requirements, including:

  • Product identification at each level of the packaging hierarchy
  • The barcode symbols to use
  • The product data to be included in barcodes
  • The data that must be stored within the Global UDI Database specified by the US FDA

The following resources are available to help you learn more:

Need more help?

We have a range of services that can help you comply with UDI regulations. Or contact us to discuss your requirements with one of our experts.