James M. Jeffords: “I now return to the Durbin amendment. Section 605, is also the subject of bipartisan agreement, with FDA's concurrence.…”

“I now return to the Durbin amendment. Section 605, is also the subject of bipartisan agreement, with FDA's concurrence. By way of brief explanation, device tracking is intended to facilitate a product recall. Current law requires tracking for certain product types and also gives FDA discretion to require tracking for other products. It simply is not necessary for every device in the mandatory category to be subject to the tracking requirement. This provision allows FDA to affirmatively 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. This provision is needed because today, FDA will often indicate to a manufacturer that a product need not be tracked, even if it is in the mandatory category. While this many be good policy in the specific case, it puts both the FDA and the manufacturer in an undesirable legal situation. This provision allows FDA to exercise proper discretion and removes any potential cloud of legal liability which exists today. It is inconceivable that FDA would not require tracking in the tragic cases identified by the Senator. The provision in the bill is logical, safe, and necessary. Further, the GAO report cited by the Senator refers to areas of FDA control totally unrelated to device tracking and surveillance.”