Medical Device User Fees

Medical Device User Fees | FDA

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/medical-device-user-fees

Oct 5, 2022

Medical Device User Fee Rates for Fiscal Year 2022

https://www.federalregister.gov/documents/2021/08/02/2021-16408/medical-device-user-fee-rates-for-fiscal-year-2022

Medical Device User Fee Amendments (MDUFA) | FDA

https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa

Annual Establishment Registration Fee: $6,493. All establishments must pay the establishment ...

Medical Device User Fee Rates for Fiscal Year 2023

https://www.federalregister.gov/documents/2022/10/07/2022-21967/medical-device-user-fee-rates-for-fiscal-year-2023

Using the inflation-adjusted fees and the 3-year averages of fee-paying submissions, collections are projected to total $330,787,011, which is $6,010,011 higher …

FDA: User Fees Explained | FDA

https://www.fda.gov/industry/fda-user-fee-programs/fda-user-fees-explained

The medical device user fees were renewed in 2007 with the Medical Device User Fee Amendments (MDUFA II), 2012 (MDUFA III), and 2017 (MDUFA IV). …

Medical Device User Fee Amendments 2022 (MDUFA V) …

https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/medical-device-user-fee-amendments-2022-mdufa-v

Virtual Public Meeting October 27, 2020 - Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027 MDUFA V Federal Register Notice …

Reduced Medical Device User Fees: SBD Program

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/reduced-medical-device-user-fees-small-business-determination-sbd-program

Login to the User Fee System MDUFA screen and enter a valid user name and password to sign into the Medical Device User Fee Website. Click the "Go" button …

FDA Announces New Medical Device User Fees for FY 2023

https://www.registrarcorp.com/fda-announces-new-medical-device-user-fees-for-fy-2023/

The U.S. Food and Drug Administration (FDA) has announced the Fiscal Year (FY) 2023 fees under the Medical Device User Fee Amendments (MDUFA). The fiscal …

FDA User Fee Programs | FDA - U.S. Food and Drug …

https://www.fda.gov/industry/fda-user-fee-programs

Complete Form FDA 3914 (User Fee Payment Transfer Request) to request a transfer of user fees paid to the FDA as directed by the Food, Drug, and Cosmetic Act …

Medical Device User Fee Amendments of 2017

https://www.fda.gov/media/165069/download

The Medical Device User Fee and Modernization Act (MDUFMA) was a law passed by the United States Congress in 2002 that allowed FDA to collect fees from medical device …