The Unique Device Identification: Direct Marking of Devices draft guidance has been released by the FDA.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:

• UDI: Direct Marking of Devices draft guidance
• Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling 
• FDA’s UDI Webpage
• FDA UDI Help Desk
• UDI Final Rule