Medical Device User Fees 2009

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Medical Device User Fee Rates for Fiscal Year 2009

https://www.federalregister.gov/documents/2008/08/01/E8-17739/medical-device-user-fee-rates-for-fiscal-year-2009

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)), and the act sets the Start Printed Page 45015 standard fee for a premarket application, including a biologic licensing application (BLA) and a premarket report, … 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

Apr 1, 2004

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 Amendments of 2017

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

medical device user fee collections, expenditures, and carryover, as well as ... spent from appropriations exclusive of user fees on the medical device review process in FY 2009 …

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 …

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 …

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 Rates for Fiscal Year 2020

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

For an annual fee for periodic reporting concerning a class III device, 3.5 percent of the standard fee; For a 510 (k) premarket notification, 3.4 percent of the …

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