The US Food and Drug Administration (FDA) has published a draft commitment letter for the sixth authorisation of the Medical Device User Fee Amendments (MDUFA VI), outlining how the agency intends to fund and operate device reviews for fiscal years 2028–2032. The letter, posted on 7 July, sets measurable targets for review times and sketches changes that could affect the regulation of artificial intelligence and other digital health technologies.
Targets for review times and the role of user fees
Under MDUFA, industry pays user fees that support the FDA's device review activities in return for commitments on review performance. The draft commitment letter proposes concrete averages for how long the FDA and industry should take to reach regulatory decisions. For the highest-risk Premarket Approval (PMA) pathway, the agency has set an average decision goal of 285 calendar days. For the most common clearance route, the 510(k) pathway, the letter proposes an initial average review timeline of 128 calendar days, with a plan to reduce this average to 112 calendar days by fiscal year 2032.
These timelines are expressed as shared outcome goals that account for both agency review activity and industry response times. The emphasis on averages reflects a continued focus on predictability and efficiency in the device-authorisation process.
What this means for AI and digital health devices
Many AI-enabled devices to date have entered the US market via the 510(k) route, which establishes "substantial equivalence" to an already marketed device. Maintaining and shortening 510(k) timelines is therefore likely to be particularly consequential for developers of algorithmic and software-driven products.
The draft letter also proposes programmatic changes to the FDA's Pre-Submission process. Among the additions is a "Focused Follow-Up" Pre-Submission option intended to streamline interactions between sponsors and the FDA, potentially accelerating time to decision for certain submissions.
- MDUFA VI period: FY 2028–2032
- PMA decision goal: 285 calendar days (average)
- 510(k) decision goal: 128 calendar days initially, reducing to 112 by FY2032
- New option: Focused Follow-Up Pre-Submission pathway
Context of negotiations and regulatory constraints
Negotiations for MDUFA VI began in October 2025, with the FDA's Centre for Devices and Radiological Health (CDRH) meeting industry representatives including AdvaMed and the Medical Device Manufacturers Association (MDMA). The draft letter memorialises those discussions, but notably does not propose new guidance documents — a departure from previous reauthorisations.
One likely reason for that omission is Executive Order 14192, which requires agencies to repeal at least ten existing regulations or guidance documents for every new one they issue. That constraint may push the FDA to focus on performance targets and process options rather than issuing fresh written guidance during this cycle.
Comment period and next steps
The FDA has opened a comment period on the draft commitment letter, which closes on 7 August. Responses from industry, patient groups and other stakeholders will inform the final terms before Congress reauthorises the user-fee legislation that underpins MDUFA.
| Item | Draft commitment |
|---|---|
| MDUFA term | Fiscal years 2028–2032 |
| PMA average decision goal | 285 calendar days |
| 510(k) average decision goal | 128 days → 112 days by FY2032 |
The draft letter's approach suggests the FDA intends to balance faster, more predictable reviews with continued oversight of higher-risk products. For AI and digital health firms, the emphasis on 510(k) throughput and a streamlined Pre-Submission path may lower time-to-market uncertainty. At the same time, firms should expect ongoing scrutiny from CDRH as the agency adapts review processes to novel algorithmic features and software modifications.
Stakeholders with an interest in device regulation should consider engaging with the public comment process before the 7 August deadline. The final MDUFA VI agreement will shape how quickly and under what standards medical devices — including software-driven and algorithmic tools — can reach patients and clinicians in the United States over the next five years.
