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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 this means in practice

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

    Primary references

    3 sources
    Link health: 2 verified 1 bot-blocked· last checked 2026-05-09
    FDA·1European Commission·1IMDRF·1
    1. 1
      FDA MDUFA
      Bot-blocked
      FDAfda.gov
    2. 2
      European Commission - Medical Devices
      Verified
      European Commissionhealth.ec.europa.eu
    3. 3
      IMDRF Documents
      Verified
      IMDRFimdrf.org

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