(As Prepared for Delivery)

Dr. Hamburg, I think we would all agree that patient safety is the priority of Congress and the priority of the Food and Drug Administration. And it is my job and the job of the HELP Committee to help you to protect patient safety to the best of our ability.

When I talk to patients in Minnesota, they also tell me that they want to be able to access medical devices that have been developed, and their doctors want to provide them with the best devices for their conditions. But too often, these devices haven't been approved by the FDA.

When I talk with medical device manufacturers in Minnesota, from the big companies like Medtronic, to smaller companies like Neurovasx ("Neuro-vase-ex"), they tell me how frustrated they are that they're developing innovative and potentially life-saving devices but they can't get them to patients-because the FDA hasn't approved them yet.

You and I both know that it takes time and effort for the FDA to thoroughly review devices for safety and effectiveness. But I believe that we can make the FDA processes more efficient, more predictable, and better support and reward biomedical innovation.