It's clear to all of us, including the FDA, that regulation does affect cost. It adds cost on top of the development of products, it adds cost on top of the use of products, and, therefore, it has an impact on the cost of health care and health care delivery in this country. This paper quickly runs through where those costs are, and, honestly, to balance them a bit with benefits. I am constantly asked, particularly this year, to re-examine the way we regulate medical devices, and look at a safety only model. My answer to that is I don't know how to look at safety only without looking at some effectiveness. I also don't know how to do risk only and not look at risk benefit. That is the type of work we at FDA do.