Any FDA UDI Experts out there?
We manufacture dental restoratives and lasers. Both have disposable 'one patient' use tips so there is no sterilization or high level disinfection required. Our Class II products require UDI numbers and labels. Now that UDI direct marking is here I want to verify my findings.
Here is the FDA requirements:
if a UDI is required on a device label, that device is also required to have a UDI permanently affixed to the device itself if the device is intended to be used more than once and intended to be reprocessed before each use
We meet the first requirement of "intended to be used more than once" however we do not meet the second requirement of "intended to be reprocessed before each use".
FDA definition of "intended to be reprocessed":
we consider a device intended to be reprocessed if it is intended to undergo high-level disinfection and/or sterilization before each use or between uses
Simple cleaning and low-level disinfection as we perform on our products do not reach the FDA definition of "intended to be reprocessed".
Based on these requirements our Class II products do not require direct marking.
Question: Am I missing something or does this sound correct?
Thank You,
Charles