again I want to tell Members I think it is important to keep their eye on the goal here and on the facts. Senator Dodd went through part of the chronology of the approval of the device that Senator Kennedy was talking about. I say to my colleagues, the system is working the way it is supposed to work. FDA has the authority. The company submitted the application, FDA cleared the device, then questions came up about it, and the FDA responded and asked for some additional material, and then they acknowledge that, yes, we had the material, you sent it to us, but we didn't get a chance to review it. We have now reviewed it.
Dan Coats: “again I want to tell Members I think it is important to keep their eye on the goal here and on the facts. Senator Dodd…”
Editor's note · Context
Discussing the FDA's approval process for a medical device.
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