Unique Device Identification (UDI) Timeline

As noted in the UDI final rule, upcoming UDI compliance dates are:

1. Class I, class II and unclassified implantable, life-sustaining or life-supporting devices have a UDI labeling and GUDID submission compliance date of September 24, 2015.

2. All life-sustaining or life-supporting devices have a UDI direct mark compliance date of September 24, 2015. Please note: Implants are not required to be directly marked.

For more information about the Unique Device Identification (UDI) System, please visit the FDA UDI webpage.


A draft guide for:

Unique Device Identification: Direct Marking of Devices
Draft Guidance for Industry and Food and Drug Administration Staff

was issued June 26, 2015 by the FDA.