FDA Raises MDUFA Users Fees for Fiscal 2021

The FDA is increasing its user fees 7.2 percent for fiscal 2021 under the Medical Device User Fee Act (MDUFA) IV.

The standard fee for 510(k) applications will increase to $12,432 from $11,594 from Oct. 1, 2020, through Sept. 30, 2021. Fees for premarket approvals will increase to $365,657 from $340,995.

The fees help the agency meet its commitments under MDUFA IV to reduce the time it takes to bring medical devices to the market.