FDA, device manufacturers make deal on user fees

Editor's Note

The Food and Drug Administration and medical device manufacturers have made a deal on user fees companies pay to have the FDA review their products, the August 23 Mass Device reports.

The Medical Device User Fee & Modernization Act IV will allow the FDA to collect nearly $1 billion in user fees over 5 years, beginning in October 2017.

Device industry lobbying groups say the new agreement is the first to include metrics aimed at reducing review times, increased interaction with FDA staff before and during reviews, and independent analyses of how the FDA manages the approval process.

The FDA and the medical device industry hammered out the principles for the user fees medtech companies pay to have the federal safety watchdog review their products. The 4th iteration of the Medical Device User Fee & Modernization Act would allow the FDA to collect nearly $1 billion in user fees over 5 years, beginning [...]