Medical Device User Fees Act

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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 place from Oct. 1, 2022 until ...

Medical Device User Fees | FDA

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

Federal law authorizes FDA to charge a fee for medical device product review. These fees apply to Premarket Notifications (510 (k)s), Premarket Approval …

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 Rates for Fiscal Year 2023

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

The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2023. The Federal …

H.R.3580 - Medical Device User Fee and Modernization …

https://www.congress.gov/bill/107th-congress/house-bill/3580

Shown Here: Passed House amended (10/09/2002) Medical Device User Fee and Modernization Act of 2002 - Title I: Fees Related to Medical Devices - (Sec. …

DEPARTMENT OF HEALTH AND HUMAN …

https://public-inspection.federalregister.gov/2022-21967.pdf

Drug, and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee Amendments of 2022 (MDUFA V), authorizes FDA to collect user fees for certain …

What is MDUFA V? - FDA - Medical Device Academy

https://medicaldeviceacademy.com/mdufa-v/

The Medical Device User Fee and Modernization Act (MDUFMA or MDUFA) is a set of agreements between the Food and Drug Administration (FDA) and the medical device industry to provide funds …

Summary of the Medical Devices Technical Corrections …

https://cacmap.fda.gov/industry/medical-device-user-fee-amendments-mdufa/summary-medical-devices-technical-corrections-act-mdtca

Designates the act as the Medical Devices Technical Corrections Act. Changes Relating to Medical Device User Fees: 2(a)(1)(A) Narrows the definition of …

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