Regulatory
Medical Device User Fee Amendments(MDUFA)
In one line
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.
Why it matters
MDUFA negotiations heavily shape FDA hiring, IT modernization, and review predictability - the biggest practical driver of CDRH responsiveness.
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- •Overlooking the continuous evolution of MDUFA commitments can lead to outdated regulatory planning.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.
Sources
- FDA MDUFA · FDA
- European Commission - Medical Devices · European Commission
- IMDRF Documents · IMDRF