Medical Device User Fee

Medical Device User Fees | FDA

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

Send a printed copy of the Medical Device User Fee Cover Sheet (Form FDA-3601) with the payment. This must include the Payment Identification Number (beginning with MD) and the FDA P.O. Box on the ...

Medical Device User Fee Amendments (MDUFA) | FDA

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

2022, with the Medical Device User Fee Amendments (MDUFA V) to the Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023. MDUFA V will be in …

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

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 Rates for Fiscal Year 2023

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

Because the estimated end-of-year FY 2022 MDUFA operating reserves of carryover user fees amount totaling $40,290,467 does not exceed the FY 2023 …

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 …

Medical Device User Fee Small Business Qualification …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-user-fee-small-business-qualification-and-certification

The Medical Device User Fee Amendments (MDUFA) require the payment of a user fee for most types of medical device applications. A business that is qualified and certified as a …

MDUFA Cover Sheets | FDA

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

FDA Center for Devices and Radiological Health. 1-800-638-2041 or 301-796-7100. Contact: Office of Communication, Training and Manufacturers Assistance FDA Center for Biologic …

MDUFA Guidance Documents | FDA

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

User Fee Guidance Documents. FY 2016 Medical Device User Fee Small Business Qualification and Certification - Guidance for Industry, Food and Drug …

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 …