Medical Device User Fees 2011

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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)), and the act sets the standard fee for a premarket application, including a BLA, a premarket report, and an efficacy supplement, at $236,298 for … 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. …

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: …

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

The Food and Drug Administration Safety and Innovation Act (Public Law 112-144) includes the Medical Device User Fee Amendments of 2012, or MDUFA III. MDUFA III will take …

User Fees and Beyond — The FDA Safety …

https://www.nejm.org/doi/full/10.1056/NEJMp1207800

The driving force behind the legislation was the need to reauthorize statutorily defined user fees that …

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

The annual fee for establishment registration, after adjustment, is set at $5,672 for FY 2022. There is no small business rate for the annual establishment …

Medical Device User Fee Amendments 2012 (MDUFA …

https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/medical-device-user-fee-amendments-2012-mdufa-iii

Medical Device User Fee Amendments 2012 (MDUFA III) Information about MDUFA III MDUFA III Commitment Letter Fact Sheet: Medical Device User Fee Amendments of …

Medical Device User Fee Amendments 2007 (MDUFA II) …

https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/medical-device-user-fee-amendments-2007-mdufa-ii

Fact Sheet: Medical Device User Fee Amendments of 2007 Comparison of Quantitative Decision Goals in MDUFMA I and II Food and Drug Administration Amendments Act …

Medical Device User Fee Rates for Fiscal Year 2012

https://www.federalregister.gov/documents/2011/08/01/2011-19335/medical-device-user-fee-rates-for-fiscal-year-2012

The FD&C Act specifies the annual fee for establishment registration for each year from FY 2008 through FY 2012; the registration fee for FY 2012 is $2,364, which is …

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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