US small businesses await MDUFMA "trigger" fix, see user fee relief ahead:
This article was originally published in Clinica
Executive Summary
A proposal to change the definition of a small business is circulating on Capitol Hill as one way of alleviating escalating device user fees. Under the Medical Device User Fee and Modernization Act (MDUFMA), only companies with sales of less than $50m currently qualify for the FDA's substantial small business user fee discount.