On September 24, 2013, the U.S. Food and Drug Administration (FDA) released a final rule requiring that most medical devices distributed in the United States carry a unique device identifier (UDI). The UDI system facilitates medical device identification, traceability and tracking through distribution and use.
The UDI system consists of three core segments. The first is the UDI, which is a unique number assigned to the version or model of a device that is required on all packaging labeling of finished goods. The UDI must include a device identifier (DI) and may contain a production identifier (PI). UDIs appear on labels in both plain text format and a format readable by automatic identification data capture (AIDC) technology (e.g., a barcode). This identifier also includes production-specific information such as the product's lot or batch number, expiration date and manufacturing date when that information appears on the label. Additionally, the date format must read as "YYYY-MM-DD" on all human-readable text (which does not include barcode text).
The second component is Direct Part Marking, which is a permanent UDI marking on the device. If a device will be used more than once and be reprocessed before each use, it must also be directly marked with a UDI, allowing accurate identification even when the device is no longer accompanied by its label or package.
The third component is the Global Unique Device Identification Database (GUDID), which is a publicly searchable database administered by the FDA that serves as a reference catalog for every device with an identifier.
UDI compliance timeline
The FDA defined a phased approach to compliance depending on the device's risk classification (reference the FDA UDI timeline chart).
BD requires that all of our suppliers implement and adhere to the FDA UDI timeline, promptly responding to queries and regular communication on UDI efforts.
Visit Unique Device Identifier (UDI) or AccessGUDID on the FDA website, or contact your BD representative for more information on the UDI system.