April 13, 2023

UDI for IVD Devices Used In-House: Part 2

Once the reagent kit components (i.e., essential parts of the finished IVD device) of an IVD are sent to the healthcare facility for clinical use, then the finished IVD is in commercial distribution (thus triggering the UDI requirements) as I understand it.  Also, the UDI requirements are generally aimed at finished devices rather than components or shipping containers. So the UDI regulations don’t generally provide for parsing the finished device up into pieces for the purposes of UDI.

Moreover, in light of the key intent of the UDI traceability requirements, the healthcare facility still has a critical interest in the proper functioning of the manufacturer’s in-house assay/test.  For example, in the event of false positives/negatives that adversely affect clinical decision making/treatment, then the fundamental intent of the UDI requirements is that all parties, including the healthcare facility, be able to link the issue back to the suspect assay/test.  Lack of assay/test UDI could prevent this fundamental intent from being met, and thus in the eyes of the UDI regulations, would represent insufficient protection of public health.

Another aspect is that if the IVD’s cleared/approved labeling, premarket authorization data [e.g., in the 510(k), PMA, EU Technical Documentation, etc.] don’t clearly restrict the assay/test to use only at the IVD manufacturer’s in-house lab (e.g., if they don’t contraindicate against use outside the manufacturer’s in-house test environment), then that also works against the notion of a UDI exemption, as such premarket authorization is contingent on UDI compliance.

Accordingly, my understanding is that the UDI requirements definitely still apply to a finished device IVD consisting of the assay/test and its reagents. If one’s strategy was to try and exempt part(s) of the commercialized finished device from the UDI requirements, then that could definitely translate to compliance risk, public health risk, and legal/liability risk.  I would at least look to assure agency authorization for such an approach before implementing it.