The Unique Device Identification: Direct Marking of Devices draft guidance has been released by the FDA. A UDI is required to be directly marked onto a device if it is “intended to be used more than once and reprocessed before each use.” (FDA) Directly marking a UDI on reprocessed devices helps to maintain accurate information and keeps the UDI in contact with the device when it is separated from packaging. The reprocessing of reusable devices typically involves processing, cleaning, and disinfection/sterilization.
Upcoming UDI compliance dates:
- September 24, 2015 – UDI labeling and GUDID submission for Class I, Class II and unclassified implantable, life-sustaining or life-supporting devices
- September 24, 2015 – All life-sustaining or life-supporting devices have a UDI direct mark