Medical Device User Fee Amendments
Statutory framework setting FDA device user fees and corresponding performance commitments, reauthorized every five years.
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. MDUFA is reauthorized every five years; MDUFA V covers fiscal years 2023 to 2027. Each agreement sets user fees for submissions and annual establishment registration, along with FDA performance goals such as review times for 510(k)s, De Novos and PMAs and targets for Pre-Sub feedback. Small businesses with qualifying revenue can apply for reduced fees.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.
- •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- •Overlooking the continuous evolution of MDUFA commitments can lead to outdated regulatory planning.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
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsFDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
FDA's most stringent device marketing application, required for high-risk Class III devices.
Voluntary mechanism to obtain FDA feedback before a formal premarket submission.
More in Regulatory
· Same categoryTwo alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
FDA voluntary program in which accredited testing labs perform standards-based testing accepted with reduced FDA scrutiny.
Where this term appears across MedTech Terms.
Sources
3 sourcesSources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 1FDA MDUFATier 2 VerifiedFDAfda.gov
- 2European Commission - Medical DevicesTier 2 VerifiedEuropean Commissionhealth.ec.europa.eu
- 3IMDRF DocumentsTier 2 VerifiedIMDRFimdrf.org
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