Unique Device Identification
Safety and effectiveness of medical devices
All UDIs are to be issued under a system operated by an FDA-accredited issuing agency opens in a new tab. The UDI system will go into effect in stages opens in a new tab, 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.The Global Unique Device Identification Database (GUDID) opens in a new tab is a database administered by the FDA that will serve as a reference catalog for every device with a unique device identifier (UDI). GUDID contains ONLY the device identifier (DI) portion of the UDI, which serves as the key to obtain device information in the database.
- 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