Medical 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

FDA: User Fees Explained | FDA

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

FDA: User Fees Explained | FDA FDA: User Fees Explained What are user fees? The FDA collects fees from companies that produce certain products, such as …

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 …

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 ...

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 …

Medical Device User Fee Amendments (MDUFA) | FDA

https://cacmap.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 registration fee. There are no waivers or reductions for small …

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 FY2022 user fee table | RAPS

https://www.raps.org/news-and-articles/news-articles/2021/8/fda-fy2022-user-fee-table

For FY2022, FDA’s fee for new drug applications (NDAs) and biologics license applications (BLAs) requiring clinical data will surpass $3 million for the first time, …

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

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

Email the completed Form FDA 3913 or Form FDA 3914 to [email protected] or to your FDA Program Manager. For questions, please contact the User Fee Helpdesk …