James M. Jeffords: “I disagree entirely with the statement made by the Senator from Illinois. The Senator's amendment strikes the agreement…”

“I disagree entirely with the statement made by the Senator from Illinois. The Senator's amendment strikes the agreement reached on these provisions among the bill's sponsors, the FDA, and Senator Kennedy. The FDA should have the discretion to decide when it makes sense to require device tracking or surveillance for a product. Current law requires tracking for certain product types and gives the FDA discretion to require tracking for other products. It is simply not necessary for every current and future device in the mandatory category to be subject to the tracking requirement. This provision allows FDA affirmatively to indicate which products in the mandatory category should be subject to tracking. FDA may use its discretion to add new products to the list of products which must be tracked, or put a product back on the list for tracking if evidence indicates the need. The FDA is overburdened. We want to free them up to do the things that need to be done. The FDA has publicly stated that it is unnecessary for all devices in the mandatory category--postmark and surveillance category--to be subject to its postapproval evaluation. I urge defeat of the amendment.”