The legal authority behind every FDA device user fee expires on 30 September 2027. That single date is why the FDA convened a public meeting on 5 August 2026.
The meeting was the FDA’s public session on reauthorising the Medical Device User Fee Amendments, covering fiscal years 2028 through 2032. It ran from 10:00 to 15:00 Eastern, in hybrid format, and it is not a formality. If Congress does not pass new legislation before that September 2027 date, the agency loses the authority to collect device user fees at all.
MDUFA pays for a large share of the people who review 510(k)s, De Novos and PMAs. The fee schedule is the part manufacturers notice on an invoice. The performance goals negotiated alongside it are the part that decides how long a submission actually sits.
The statute sets out the order of play, and the agency is working through it in the open:
- negotiate with industry, and consult public stakeholders periodically
- publish the recommendations in the Federal Register
- hold a public meeting on those recommendations, which is what 5 August was
- leave 30 days for written comment afterwards
- revise the recommendations in light of what comes back
That 30 day window is the part still worth acting on. It runs after the meeting rather than instead of it, so missing the session costs nothing if a written submission goes in. Anyone with a view on review timelines has a narrow, real opportunity here, and most companies will let it pass.
The fee numbers will get the coverage. The goals deserve more of it. A modest rise in the establishment registration fee is an annoyance; a change to how many rounds of additional information a submission can absorb before the clock resets changes the plan for a 2029 launch. Worth watching which of the two moves further from the published recommendations by the time this reaches Congress.
Full details of the meeting are on the FDA’s announcement page.