AdvaMed: MDUFA Agreement Could Be ‘Game Changer’ for FDA, Industry

A compromise reached by the FDA and device industry on medical device user fee reauthorization should benefit both parties and speed patient access to innovative technologies, AdvaMed President Stephen Ubl said. “We believe this agreement is a potential game changer,” he told reporters in a Feb. 1 conference call. The agreement in principle on reauthorization of the Medical Device User Fee Act (MDUFA) — reached late Jan. 31 — came after a year of tough negotiations.
Devices & Diagnostics Letter