Compliance: The Food and Drug Administration passed a law in 2007 that requires a Unique Device Identification (UDI) to be implemented on medical devices and packaging with a specifically formatted machine-readable code.
Directly applied UDI marks should meet many criteria:
- Not affect the surface finish of the device negatively
- Must not corrode or fade
- Ensure counterfeit protection
- Marked in high contrast
- Legible and readable
- Remain stable through multiple high alkaline sterilization and cleaning procedures