Combination products have been controversial topic since the introduction of 21 CFR part 4 in 2013. Combination products can consist of Drug & Device, Biologic & Device, or drug/Biologic. Most Drug and Biologic products requires Clinical trials that are divided into phase I, Phase IIa, Phase IIb and Phase III. During phase I clinical studies, the device may not be fully designed and it may not have full functionality. The main question is What Design controls and Design transfer activities are required for phase I clinical studies.