President Signs Device User Fee Renewal Bill

A bill reauthorizing the FDA’s drug and medical device user fees for the next five years became law Aug.18 when President Trump signed it.

The bill, given near-unanimous approval by Congress, was the culmination of two years of work and negotiations with industry.

The FDA Reauthorization Act of 2017 (FDARA) is expected to bring in $1.42 billion in fees — about a quarter of the agency’s budget, over the next fiscal year — including a 45.2 percent increase in medical device fees over the $126 million anticipated from MDUFA this fiscal year.

The newly authorized user fees will apply to applications received by the FDA on or after Oct. 1.