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 abili...
Americans have a right to know that the money Washington takes from them is well spent.
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 enab...
Thank you, Mr. Chairman.
I think that's critical.
Moreover, the agency may not ask for scientific evidence, greater than the 'least burdensome,' to answer the question.
One complaint that I continue to hear from constituent companies is that the FDA's medical device review process is unpredictable and incons...
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...
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?
Do you acknowledge that an increase in the user fee is eventually passed on to the consumer?
Have you recognized any suppliers lower down the chain of parts that have repeatedly been found to have counterfeit parts being used?
I guess the question is how comfortable do you feel now with these protocols that you have put in place.
I have a strong sense of making sure that we can serve those lands.
I think we have gotten good information. And I also think what we have discussed speaks volumes about the need for financial literacy educat...
