Adding a UDI Compliant Label to previously manufactured devices



From what I understand of the FDA UDI final rule, Class II implantable devices are excepted from the final rule for 3 years. For our class II orthopedic devices, that 3 year deadline is September, 2018. We have started the process of removing devices from inventory and distribution to relabel with a UDI compliant label.

I keep reading from various industry sources that this removal effort is not reportable to FDA. Does anyone know of an FDA document that states this? Unless my eyes are failing me, I have not been able to find a reference document.

Thanks in advance.
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