FDA’s unique device identification system includes unique device identifier (UDI) labeling (21 CFR 801.20) and data submission requirements (21 CFR 830.300). The unique device identification system regulations require that the label and device package of a device must bear a UDI, unless an exception or alternative applies. An exception is provided at 21 CFR 801.30(a)(11) for devices packaged within the immediate container of a convenience kit, if the label of the convenience kit bears a UDI.

This guidance describes FDA’s interpretation of the definition of “convenience kit” at 21 CFR 801.3 and as used in 21 CFR 801.30(a)(11). This guidance does not apply to in vitro diagnostic (IVD) devices that are subject to the IVD labeling requirements under 21 CFR part 809, nor does it apply to combination products as defined in 21 CFR 3.2(e).

Terms clarified within this guidance apply only for purposes of this guidance document and the UDI regulations, and are not intended to be applied beyond the regulations and policies pertaining to the unique device identification system. This guidance does not define the term “convenience kit” for other regulatory purposes. Further, this guidance does not suggest that compliance with the UDI regulations eliminates the need to comply with any other applicable requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act or its implementing regulations.