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:
- Our latest UDI white paper prepared by Kodit, Motorola and Zebra
- Getting Ahead of the Game white paper on UDI by Prisym ID
- Read the US FDA regulation in more detail
- Find out more about the UDI database and how to use it with the User guide for US FDA UDI database
- Watch the US FDA presentation on the new regulation which provides a straight forward introduction
- Press release - GS1 accredited by US regulator as official issuing agency for medical device identifiers