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Device Registration and Listing | FDA

    https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing
    Fee. FY 2023. $6,493. Generally, establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those...

Medical Device User Fee Amendments (MDUFA) | FDA

    https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa
    Annual Establishment Registration Fee: $6,493. All establishments must pay the establishment ...

Medical Device User Fees | FDA

    https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/medical-device-user-fees
    The Medical Device User Fee Cover Sheet and instructions are available online. Applicants must register to create a Medical Device User Fee Cover Sheet. To …

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
    MDUFA specifies that the base fees of $329,000 (premarket application) and $4,978 (establishment registration) are to be adjusted for FY 2022 using the same …

Payment Process | FDA - U.S. Food and Drug …

    https://www.fda.gov/medical-devices/device-registration-and-listing/payment-process
    Payment Process | FDA Payment Process All establishments required to register must first visit the Device Facility User Fee website to pay the user fee. Once you make payment …

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 …

How Much Is the FDA Medical Device …

    https://www.qualio.com/blog/fda-medical-device-registration-fee
    How Much Is the FDA Medical Device Registration Fee in 2022? The FDA medical device user fee for 2022 is $5,672. However, there are other application fees medical device …



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