In September 2013, FDA announced a new series of regulations designed to make it easier to track medical devices as they move through the supply channel chain. The Unique Device Identification (UDI) system requires manufacturers (and distributor’s private label products) to carry a unique bar code (similar to bar codes on grocery store products) on the package or the device itself.
Deadlines for UDI bar codes on the device or the packaging:
- September 2014 for Class III devices
- September 2016 for Class II devices
- September 2018 for Class I devices
As you navigate the UDI guidelines and implementation requirements, Medical Device Online provides some informative articles about UDI that may answer some questions your company may have:
A five part UDI article series, by Dan O'Leary
FDA's New UDI Rule: What Device Makers Need To Know, by Jim Pomager
Permission to link to articles granted by http://www.meddeviceonline.com/.
If you have further questions about UDI, please contact us for regulatory guidance and consulting.