Device manufacturers take note: Changes in regulations accompanying the Unique Device Identifier (UDI) regulation took effect on December 23, 2013. The new UDI regulations reach far and wide. In addition to creating a new regulation at 21 CFR 830, changes also permeate the device regulations for:
- labeling – all device labels will bear a UDI, according to specific requirements and exemptions
- medical device reporting – adverse event reporting will include a UDI
- corrections and removals, recalls, device tracking, and postmarket surveillance – FDA will identify devices involved by their UDIs
- Quality System Regulations – firms must include UDI processes in their QSRs
Manufacturers must apply these changes to all of their applicable standard operating procedures. There is no doubt that FDA investigators will bring this up in future inspections and eventually FDA could bring adulteration or misbranding charges.
You might have one, two, or even three years to begin using a UDI, but the deadline for implementing the required changes in your SOPs was December 23. FDA inspectors will start asking about how you have implemented the SOP provision, so it is the time to get help if you need it.
