Medical Device User Fee Legislation

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

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 …

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

House Passes FDA Package Reauthorizing Drug, Device User Fees

https://news.bloomberglaw.com/health-law-and-business/house-passes-fda-package-reauthorizing-drug-device-user-fees

The vote marks a pivotal step in reauthorizing the user fees the Food and Drug Administration gets from the drug and medical device industries for fiscal years …

Medical Device User Fee Amendments; Public Meeting; …

https://www.federalregister.gov/documents/2022/04/07/2022-07451/medical-device-user-fee-amendments-public-meeting-request-for-comments

The Food and Drug Administration (FDA, the Agency, or we) is announcing a virtual public meeting entitled “Medical Device User Fee Amendments.”. The purpose of …

Overview of Device Regulation | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation

On October 26, 2002 the Medical Device User Fee and Modernization Act of 2002 became law. It authorizes FDA to charge a fee for medical device Premarket …

House Passes FDA User Fee Package, Awaits Senate …

https://www.aamc.org/advocacy-policy/washington-highlights/house-passes-fda-user-fee-package-awaits-senate-action

The House of Representatives passed the Food and Drug Amendments of 2022 (FDA22, H.R. 7667) on June 8 by a bipartisan vote of 392-28.The bill was approved …

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 …

Eshoo’s FDA User Fees Legislation Passes House in …

https://eshoo.house.gov/media/press-releases/eshoo-s-fda-user-fees-legislation-passes-house-bipartisan-vote

WASHINGTON, D.C. – Today Congresswoman Anna G. Eshoo (CA-18), Chairwoman of the Energy and Commerce Health Subcommittee, hailed House passage …

Eshoo’s FDA User Fees Legislation Passes House in …

http://eshoo.house.gov/media/press-releases/eshoo-s-fda-user-fees-legislation-passes-house-bipartisan-vote

WASHINGTON, D.C. – Today Congresswoman Anna G. Eshoo (CA-18), Chairwoman of the Energy and Commerce Health Subcommittee, hailed House passage …