Starting in September, class II medical devices will be required to be equipped with a unique device identifier to be in compliance with UDI regulations.
The U.S. Food and Drug Administration passed the final rule establishing a UDI system in September 2013. The rule requires many medical device labels and packages to have a unique number so every product can be adequately tracked.
In September 2014, the first compliance deadline for UDIs took effect, requiring class III medical devices to be labeled with a UDI and for device data to be submitted to the Global Unique Device Identification Database, which contains information on these devices and facilitates their identification. Now, the compliance deadline for class II medical devices to bear a UDI is Sept. 24.
The FDA is taking a phased approach to UDI compliance. Following class III and class II medical devices, class I devices will need to have UDIs by September 2018.
Click here for a compliance timeline table.
More articles on UDIs:
Geisinger, Kaiser applaud unique device identifier requirements in MU
FDA launches website opening database of UDIs to public
Implementing UDIs into EHRs: A guide to patient safety