Definition of Convenience Kit for a Combination Product

S

Samuel

In the document released by FDA it defines convenience kit for a combination product as;

If the kit includes only products that are 1) legally marketed independently and 2) packaged in the kit as they are when independently marketed (including any labeling used for independent marketing), it is a “convenience kit” and the only manufacturing steps for the combination product would be the assembly, packaging, labeling, any sterilization, and further processing of the kit itself.

Our kit will be composed of two drug products each ANDA approved and a 510(k) cleared device. These drug and device components will be assembled into a single unit and put it in a kit for convenience of users. In this context, the question arises: Does this additional assembly process hurt the definition of convenience kit for a combination product? I want to hear your thoughts.

Regards,
Sam
 
Top Bottom