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.
Official resources
Full compliance as of 2020
Devices already in commercial distribution before their respective compliance date were subject to a transition period; however, any device repackaged or relabelled after the compliance date must comply with UDI requirements regardless of the original clearance/approval date.