The Medical Device User Fees (MDUFA) have been announced for FY 2026! The Federal Register (FR) Notice can be found here. See the Lachman blog for additional posts regarding user fees: GDUFA, BSUFA, PDUFA, and ADUFA. Across the board, for both standard and small businesses, fees increased by 7.1% with the exception of establishment fees, which increased […]
Today, the Federal Register announced the 2022 MDUFA fees (here). As the FDA notes, “This notice establishes the fee rates for FY 2022, which apply from October 1, 2021 through September 30, 2022, and provides information on how the fees for FY 2022 were determined, the payment procedures you should follow, and how you may […]
Today, the announcement of the User Fees for three FDA programs today were published in the Federal Register notice prepublication. PDUFA, animal and generic drug fees and medical device fees for FY 2021 start October 1, 2020 and are provided below. We await the GDUFA fee announcement, which we should see in a day or […]
