In agree that the FDA may be more interested in insuring that the design controls for a specific device is within the FDA standards. For example, when a company send in a new IND to the FDA for a new drug. They are now just going to investigate to make sure that the design controls around the development and safety of the drug is within standards. I believe that If that drug is being manufactured and going through clinical trials that the equipment, operator/scientist and Protocols behind how this drug is developed is of great importance as well.