FDA says MDUFA VI will prioritize review consistency and domestic focus over faster timelines

FDA officials explained that the next Medical Device User Fee Amendments, known as MDUFA VI, will aim to improve consistency in the review process.

The agency said the new framework will emphasize domestic priorities, supporting U.S. manufacturers and patients.

Unlike the previous MDUFA V, the focus will not be on shortening review timelines but on delivering more predictable outcomes.