The Unique Device Identification (UDI) System is intended to assign a unique identifier to medical devices in all geographies. A national UDI system creates a common vocabulary for reporting and enhance electronic tracking abilities. Without a common vocabulary for medical devices, meaningful analysis based on data from existing voluntary systems is problematic. Reliable and consistent identification of medical devices enables safety surveillance so that the regulatory authorities and manufacturers can identify potential problems or device defects and improve patient care.

The Food and Drug Administration (FDA) requires most medical devices distributed in the United States to carry a unique device identifier. The Unique Device Identification (UDI) module allows users to comply with this rule.

The regulatory agencies in new geographies requires the medical devices distributed in different areas to have a unique device identifier and a common location to store the UDI Super Set data.

To create unique device identifiers and submit them to the FDA, see Working with Unique Device Identification.