Is this the reason BIEL has not been approved? "But FDA still hasn’t arrived at a deal with companies on user fees for medical devices—the FDA made a proposal, but industry rejected it, so the negotiations continue." The user fees should be eliminated,the FDA is a Gov. agency so let them get their funds from the Gov. The Gov. should tax the drug companies more and give the FDA what it needs to operate.Maybe that would get rid of all the dangerous drugs that are on the market. JMO