The FDA UDI mandate calls for the placement of Device Identifiers (DI) and Production Identifiers (PI) on a UDI label. The former is a static portion of a UDI label that identifies the labeler and the specific device version or model, while the latter represents the conditional variable portion of a UDI label that can be used to ID one of a number of attributes specific to a device such as:
- a manufacturing lot or batch number;
- a unique serial number;
- the date manufactured;
- the expiration date;
- for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device, the distinct identification code required by §1271.290(c).
The FDA UDI mandate further stipulates that the actual “labeler” is ultimately responsible for meeting labeling and Global UDI Database (GUDID) data submission requirements (as well as the direct marking and date format requirements where applicable). Finally, FDA UDI requirements call for UDI labels be durable enough to last throughout the life-cycle of a given medical device. The label must not only remain affixed to the device, but the information displayed on the label must be human-readable as well as in an AIDC format throughout the product’s life.
Sample UDI Label of a Fictitious Medical Device