Americans deserve an efficient, effective government that works for them.

Americans have a right to know that the money Washington takes from them is well spent.

My concern, to allude to what Mr. Lynch talked about, we may be having many hearings on this unless there seems to be some indication that there is going to be resolution of this problem.

Our solemn responsibility is to hold government accountable to taxpayers.

You should do that, shouldn't you?

I think that's critical.

Moreover, the agency may not ask for scientific evidence, greater than the 'least burdensome,' to answer the question.

I really remain concerned about their force protection, the individuals that are remaining in Iraq.

Iraqi counterterrorism forces in partnership with the U.S. special operations personnel have significantly degraded al Qaeda in Iraq's ability to conduct these spectacular attacks.

Do you acknowledge that an increase in the user fee is eventually passed on to the consumer?

One complaint that I continue to hear from constituent companies is that the FDA's medical device review process is unpredictable and inconsistent.

In North Carolina, we employ over 8,000 people in the medical technology industry, and it's an industry that really does create thousands of jobs.

I'm concerned that duplicative regulation could slow innovation, impeding improvements to patient care as well as the job growth.

I'm wondering if and how FDA can speed this up now?

I commend the FDA on their decision on the 510(k) because I think that it does embrace what it set out to.

I think you've got to weigh in this equation. How much are we increasing the cost of devices?

If I reference the IOM report again here, in the United States, use of clinical data in the regulatory review process is defined by the enabling legislation, regulations and FDA's implementation of the legislation and regulations.

Thank you, Mr. Chairman.