FDA is looking to make sure that all required elements of a design control system are in place, but more importantly, they are looking to see if the products that companies are developing are following the design control procedures. I believe that an important element of having a complete design control system is how well the company adheres to it design controls. I don’t think that FDA issues many findings for an incomplete design control system, because every medical device company knows exactly what design controls need to be in place, so in order to develop a medical device to be cleared by FDA they would have to have a design control system conforming to FDA requirements. However, where companies most often get into trouble is by deviating from their design controls, so I would say FDA is especially focused on looking to see if you are following your own design control procedures.