UDI Compliance Dates by Device Class
UDI phase-in timeline
FDA implemented UDI requirements in phases based on device class:
| Device class | UDI label compliance | Direct marking (reusable devices) | GUDID submission |
|---|---|---|---|
| Class III | September 24, 2014 | September 24, 2015 | September 24, 2014 |
| Class II | September 24, 2016 | September 24, 2018 | September 24, 2016 |
| Class I and unclassified | September 24, 2018 | September 24, 2020 | September 24, 2018 |
| Implantable, life-supporting, life-sustaining | September 24, 2015 | September 24, 2015 | September 24, 2015 |
Full compliance as of 2020
As of September 24, 2020, all device classes are required to comply with UDI labelling requirements. New devices entering the market after this date must comply from the date of commercial distribution.