Jeff Merkley actually said...

"It does seem like using a flawed design as a foundation for approving another device under 510(k) is something that we need to wrestle with."

"I am really hoping we can try to solve this problem because when patients are told, 'Well, we are partway through your cancer treatment, and we cannot get the drugs.'"

"I am working with some other folks to develop a bill, if necessary, to basically put a deadline on getting this rule accomplished."

"I believe that the UDI rule is currently stalled at OMB. Any insights on how we can get that rule accomplished in order to have these benefits?"