In 2013, the Food and Drug Administration (FDA) released a final rule establishing a unique device identification (UDI) system designed to adequately identify devices through distribution and use. UDI will improve patient safety, modernize device postmarket surveillance, and facilitate medical device innovation.
The final rule requires device labelers to include a unique device identifier (UDI) on device labels and packages, except where the rule provides for an exception or alternative. Each UDI must be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI on the label of devices will be in human and machine-readable form.The UDI will also be required to be directly marked on a device that is intended for more than one use, and intended to be reprocessed before each use. Dates on device labels and packages are to be presented in a standard format that is consistent with international standards and international practice.
All UDIs are to be issued under a system operated by an FDA-accredited issuing agency. The UDI system will go into effect in stages, over a period of seven years, to ensure a smooth implementation and to spread the costs and burdens of implementation over time, rather than having to be absorbed all at once.
As part of the system, the device labelers are required to submit information to the FDA-administered Global Unique Device Identification Database (GUDID). The GUDID will include a standard set of basic identifying elements for each device and most of this information will be made available to the public so that users of medical devices can easily look up information about the device. Neither the UDI nor the GUDID database will contain any information about who uses a device, including personal privacy information.
- FDA Final Rule – Unique Device Identification System: September 24, 2013
- Implementation – Unique Device Identification-Implementation Guide– from Premier Research Institute, 2015
- Resources on UDI and GUDID on FDA UDI Resources website