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    Medical Device User Fee Amendments

    Statutory framework setting FDA device user fees and corresponding performance commitments, reauthorized every five years.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    MDUFA (currently MDUFA V, FY2023–2027) ties industry-paid user fees to FDA performance goals on review timelines, total time to decision, and program improvements such as the Q-Sub program and Total Product Lifecycle Advisory Program.
    What the regulation says
    The Medical Device User Fee Amendments (MDUFA) program, authorized by Congress and renewed periodically, allows the FDA to collect fees from medical device companies. In exchange for these fees, the FDA commits to meeting specific performance goals related to the review of medical device submissions, as outlined in the commitment letter negotiated with industry, for example, MDUFA V for fiscal years 2023-2027.

    What this means in practice

    MDUFA negotiations heavily shape FDA hiring, IT modernization, and review predictability - the biggest practical driver of CDRH responsiveness.

    Examples

    • A manufacturer planning a novel device submission considers the established MDUFA V review targets for Premarket Approval (PMA) applications when setting their project timeline.
    • During MDUFA negotiations, industry representatives advocate for clearer performance metrics for 510(k) reviews to improve predictability for new medical devices.
    • An emerging MedTech company budgets for MDUFA user fees as a mandatory expense before submitting its device for FDA clearance or approval.
    Common pitfalls
    • •Failing to account for MDUFA-driven FDA priorities can lead to misaligned submission strategies.
    • •Assuming MDUFA performance goals guarantee individual submission timelines is a common but incorrect expectation.
    • •Ignoring the impact of MDUFA negotiations on FDA resource allocation can result in an incomplete understanding of review processes.
    • •Overlooking the continuous evolution of MDUFA commitments can lead to outdated regulatory planning.
    • •Misinterpreting MDUFA as solely a funding mechanism, rather than a performance agreement, undervalues its regulatory impact.

    Frequently asked questions

    The primary purpose of MDUFA is to provide the FDA with additional resources for the review of medical device applications, in exchange for which the agency commits to specific performance goals and review timelines.
    Grouped by theme

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    FDA·1European Commission·1IMDRF·1
    1. 1
      FDA MDUFA
      Verified
      FDAfda.gov
    2. 2
      European Commission - Medical Devices
      Verified
      European Commissionhealth.ec.europa.eu
    3. 3
      IMDRF Documents
      Verified
      IMDRFimdrf.org

    Inline markers like [1] jump to the matching reference above.