Political Quotes

“This device is being used to try and improve biopsy and diagnostic purposes and reduce, hopefully, the need for unnecessary surgery--something most people applaud. And the label clearly limits the product to that purpose. The Senator from Massachusetts suggests that this is somehow a rationale for us to reduce or change the language of this bill that deals with the approval process for less riskier medical devices. He cites a lot of examples that has nothing to do with this issue. Fen/ phen has nothing to do with this amendment. The Dalkon shield has nothing to do with this amendment; that was a failure of technology that had nothing to do with the intended purpose of the device. The examples cited, one after another, do not address the issue at hand. The issue at hand is how the FDA interprets intended use in making a substantial equivalence determination --the first test a lower risk device undergoes. That is what we are dealing with here. If you have to say to a company that it must try and imagine what a device conceivably could be used for by some surgeon out there, and on that basis FDA can hold up its 510(k), you might as well scrap 510(k) and make every new device, even low-risk ones, go through the PMA process. You can make a case for that, I suppose. But I don't hear anyone advocating that. But if you really believe that we ought to so change this process, then get rid of 510(k) altogether--that is the safest way to go.”