UDI requirements for pre-filled combination devices - Box containing a pre-filled device


I have a product that has an outer box that contain 2 inner boxes (these 2 inner boxes contain each a prefilled device with the same amount of a drug).
The item sold to customers is the outer box.

For now, the outer box artwork displays (among other things) the Serial number and not the UDI since my colleague says that a box containing a pre-filled device doesn’t need UDI.

Is my colleague correct? Can the UDI be omitted because the device is pre-filled?


Ronen E

Problem Solver
Staff member
Super Moderator
Does this help?
§801.30 General exceptions from the requirement for the label of a device to bear a unique device identifier.

(b) National Drug Code (NDC) Numbers. If a combination product properly bears an NDC number on its label—
(1) The combination product is not subject to the requirements of §801.20.

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