Medical Device User Fees 2010

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Medical Device User Fee Rates for Fiscal Year 2010

https://www.federalregister.gov/documents/2009/08/03/E9-18456/medical-device-user-fee-rates-for-fiscal-year-2010

The Food and Drug Administration (FDA) is announcing the Start Printed Page 38445 fee rates and payment procedures for medical device user fees for fiscal year (FY) 2010. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device User Fee and Modernization Act of 2002 … See more

Medical Device User Fees | FDA

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

Complete the Medical Device User Fee Cover Sheet (Form FDA-3601) online. The Medical Device User Fee Cover Sheet and instructions are available online. …

Summary of the Medical Device User Fee and …

https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/summary-medical-device-user-fee-and-modernization-act-2002

The user fees authorized by MDUFMA are intended to add $25.1 million to FDA's medical device budget authority during FY 2003, rising each year until fees …

Fact Sheet: Medical Device User Fee Amendments of 2012

https://www.fda.gov/regulatory-information/food-and-drug-administration-safety-and-innovation-act-fdasia/fact-sheet-medical-device-user-fee-amendments-2012

Under MDUFA III, the FDA is authorized to collect user fees that will total approximately $595 million (plus adjustments for inflation) over five years. With this additional funding, …

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 (MDUFA) | FDA

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

Medical Device User Fee Amendments (MDUFA) | FDA Medical Device User Fee Amendments (MDUFA) User Fees for FY2023 Annual Establishment Registration Fee: …

Medical Device User Fee Rates for Fiscal Year 2011

https://www.federalregister.gov/documents/2010/08/03/2010-19038/medical-device-user-fee-rates-for-fiscal-year-2011

Under the act, all submission fees and the periodic reporting fee are set as a percent of the standard (full) fee for a premarket application (see 21 U.S.C. 379j(a)(2)(A)), …

FDA Regulation of Medical Devices

https://crsreports.congress.gov/product/pdf/R/R42130

appropriations and user fees collected from device manufacturers, which together comprise the program level budget. User fees account for 43% of FDA’s total FY2016 program …

Medical Device User Fee Rates for Fiscal Year 2020

https://www.federalregister.gov/documents/2019/07/31/2019-16270/medical-device-user-fee-rates-for-fiscal-year-2020

The annual fee for establishment registration, after adjustment, is set at $5,236 for FY 2020. There is no small business rate for the annual 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 …

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