Dan Coats: “Section 404, the section under debate, preserves a very key premarket statutory authority to the agency. It is important…”

“Section 404, the section under debate, preserves a very key premarket statutory authority to the agency. It is important for Members to understand that the agency can call, still call for a premarket action requiring full data on the safety and effectiveness whenever there is a technological difference arising, and I quote from the statute, ``that raises different questions of safety and effectiveness in the earlier approved device.'' This authority is premarket. In other words, the product is never cleared for marketing. It is never distributed before the agency has an opportunity to act. The authority is extremely broad. As soon as a product raises a question about safety and effectiveness, the agency can require the filing of a premarket authority, PMA. The agency retains full discretion to control the showing of safety and effectiveness. There are no words of limitation on that statutory authority. I point out that that authority has never been challenged successfully by a company in court.”