Medical Device User Fee Amendments (MDUFA VI)
The Medical Device User Fee Amendments (MDUFA) authorise FDA to collect user fees from medical device manufacturers in exchange for commitments to meet defined review performance goals. MDUFA must be reauthorised by Congress every five years.
MDUFA history
| Version | Period | Key changes |
|---|---|---|
| MDUFMA (I) | FY2003–2007 | First device user fee legislation |
| MDUFA II | FY2008–2012 | Expanded fee types, increased accountability |
| MDUFA III (FDASIA) | FY2013–2017 | Enhanced transparency, De Novo fees added |
| MDUFA IV | FY2018–2022 | SaMD guidance commitments, Q-Sub programme |
| MDUFA VI | FY2023–2027 | Current |
MDUFA VI — current cycle (FY2023–2027)
Performance goals
| Submission type | Total Time to Decision goal |
|---|---|
| 510(k) — standard | 90 calendar days |
| 510(k) — Special | 30 calendar days |
| De Novo request | 150 calendar days |
| Original PMA | 180 calendar days |
| PMA Panel Track Supplement | 180 calendar days |
| PMA Real-Time Supplement | 90 calendar days |
| HDE original | 180 calendar days |
FY2026 fee schedule (approximate)
| Fee type | Standard | Small business |
|---|---|---|
| 510(k) premarket notification | ~$23,170 | ~$5,793 |
| De Novo request | ~$23,170 | ~$5,793 |
| Original PMA | ~$432,235 | ~$108,059 |
| PMA supplement (180-day) | ~$324,176 | ~$81,044 |
| Establishment registration | ~$7,653 | ~$1,913 |
Fees are updated annually each October. Check FDA's user fee website for current amounts.
Small business qualifications
A small business for MDUFA purposes has annual gross receipts or sales of ≤ $100 million, including affiliates. Small businesses pay approximately 25% of standard fees for most submission types.
How MDUFA shapes FDA review
MDUFA created a performance-based accountability system:
- FDA publishes quarterly MDUFA performance reports measuring actual TTD against goals
- If FDA misses goals, it must explain why in its annual report to Congress
- The fee agreement is negotiated every five years between FDA, industry (AdvaMed, MITA), and Congress