In September 2013, FDA (through a Congressional mandate) 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. (In some cases, a direct mark is required on certain implantable devices).
Deadlines for UDI bar codes on the device or the packaging:
- September 2014 for Class III devices
- September 2016 for Class II devices
- September 2020 for Class I devices
As you navigate the UDI guidelines and implementation requirements, DTA provides some informative articles about UDI that may answer some questions your company may have:
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.