The FDA has established a unique device identification (UDI) system to identify and trace medical devices throughout their distribution and use. The UDI Final Rule was published 24th September 2013.

UDI is expected to improve greatly upon patient safety and healthcare industry processes by implementing a global system of standards which is fundamental to enabling traceability of medical devices across all healthcare stakeholders worldwide.

As part of this mandate, labels on medical devices must contain a unique device identifier (UDI) code in human- and machine-readable form. The machine-readable form must be able to be interpreted by automatic identification and data capture (AIDC) technology; that is, a barcode symbol or machine-readable text (OCR) that can be decoded by a barcode reader or machine vision system.