FDA’s final rule on combination products (21 C.F.R. Part 4) set forth current good manufacturing practice requirements that must be met for the entire product (drug/device or biologic/device), regardless if the device design occurs internally or externally to the Marketing Authorization Holder (MAH).  Although many elements of CP cGMPs are well understood, it appears many are focused on understanding design control and supplier evaluation in the context of the new regulation and guidance.