FDA today made recommendations to Congress for reauthorizing the Medical Device User Fee and Modernization Act. The agency says the reauthorized program, called MDUFMA II, would give companies predictable fees and speedier review times. And small device makers stand to gain additional benefits, the agency said in its announcement. Under the current program, companies with $100 million or less in annual sales pay 80 percent of the full fee. With MDUFMA II, those companies would pay just 50 percent for 510(k) applications, and 25 percent for pre-market approvals and related supplement fees (now they pay 38 percent). FDA would continue to waive the fee for all first-time pre-market approval applications for businesses with $30 million or less in sales. MDUFMA II also would allow a mechanism for foreign businesses to qualify as small businesses. FDA is accepting public comments on the proposal for the next 30 days and is holding a public meeting on April 30.