Hello Anon,
Without seeing the full kit configuration, in most likelihood the standards and controls would need a different Unique Device Identification (UDI). Always remember the UDI number is from the user perspective in order for them to have identification and traceability. Therefore, if the standards and controls are sold separately, if there is any issue with these components, then they would have their own identification and traceability for the user (say to report as a complaint). While it does not address this situation specifically, the US FDA guidance documents speak about packaging configurations, components, and how would be placed at different levels of packaging.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 07-Apr-2023 09:28
From: Anonymous Member
Subject: UDI requirement for IVD components
This message was posted by a user wishing to remain anonymous
Hi All,
We have an IVD finished kit that is a class II device in the US.
The kit comes with standards and controls. If we have to ship these separate from the IVD finished kit, what are the labeling requirements? Do they need their own UDIs on the labels, one for standards and one for controls?
Thank you!