Submission for a cross-labelled combination product

[VirginiaA]

I am working on a cross-labelled combination product (the device and drug parts are manufactured and packaged separately but are both required to achieve the intended use). Doe anybody have experience with preparing a submission for a cross-labeled device? Do you prepare a DHF for the device and the NDA required information for the drug in two separate dossiers? Are there any device design controls that may apply to the drug part?

Thanks!!