Political Quotes

“let me say briefly to my colleagues that what I believe is false and misleading is to suggest what we are trying to do in any way is something injurious to the American consumer. What we are doing is saying that we shouldn't create roadblocks in a process that has been in place for more than 20 years and that has worked well for lower risk devices. To prove a device is substantially equivalent to a product that has already been in the marketplace there are tests which must be complied with, but you don't force the product to prove itself all over again. That negates the process that was set up to be quicker and more efficient and makes patients wait too long to get access to devices which can change their lives, even save their lives. If you want to scrap the process altogether and require that every new variation of the predicate product begin this process all over, then let's do that. I don't hear anyone calling for that. What the law says is that if it's substantially the same product and if the intended purpose as stated is the same, you don't ask the company to try to guess how someone may use that product for some purpose that the company has not supported. To suggest that a company is going to have to guess as to what other ideas someone may have for the use of that product, and develop data to support those uses--that would make this process null and void. We might as well scrap the entire section and 25 years of effort here.”