Revisiting User Fees

Originally Published MX January/February 2005

INDUSTRY ASSOCIATIONS

In light of current failings, careful collaboration will be required to preserve the future of medical device user fees.

Mark Leahey

When Congress passed the Medical Device User Fee and Modernization Act of 2002 (MDUFMA, or the user-fee act), the goal of the user-fee program it created was to provide FDA with the resources it needed to review fully and in a timelier manner the safety and effectiveness of new medical devices. More than two years have passed since the inception of the program, time enough for many in the medical technology industry to evaluate seriously whether it is working as originally intended.