Jack Reed: “What we have done in the overall FDA law is create an incentive for companies, under section 510(k) to get approval of…”

“What we have done in the overall FDA law is create an incentive for companies, under section 510(k) to get approval of class I and II devices, to go out and pick out existing devices and say the new device is substantially equivalent. This, I think, provides pressure for companies to go out and simply say we are going to do exactly what these other devices do, even though their new design might have many more capabilities. This is not an academic problem. Take, for example, the issue of a biopsy needle. Typically these needles are very small. They remove a very small amount of tissue, about the size of a pencil tip. If the FDA was presented with a new biopsy needle that was claimed to be simply for biopsy of tissue but in fact removed 50 times that amount of tissue, a much, much larger bit of tissue, the suspicion would be that this is not just for biopsies, it's actually to remove the lesion. Yet under this law, today, as we speak, they could not look behind that claim on the label. They could not look behind it and say, give us some data about the removal of lesions. This is a serious public health problem. That is what we are addressing today.”