ARTICLE SUMMARY:
In this week’s Pathways Picks: FDA announces FY 2026 user fee increases, MDUFA VI meeting agenda, and digital health resources; Australia TGA details AI device reform plans; UK NICE supports mental health chatbots; notified bodies propose new EU device governance body; China addresses classifications; and Japan and South Korea renew pact.
[Editor’s note: Pathways Picks will not be published on August 6 and August 13. We will resume our Wednesday releases on August 20.]
FDA Picks
User fee hike, meeting agenda, digital resources:
Registration fee up 23%. Every device firm will pay $11,423 to register each of its facilities with FDA next fiscal year, up 23% from the current $9,280 annual establishment registration fee. The FY 2026 increase, announced July 29, is tied to inflation plus a MDUFA V “performance improvement adjustment” that FDA qualified for because it met its FY 2024 timing goals for providing Pre-Submission written feedback and De Novo decisions. Fees for premarket submissions including PMAs and 510(k)s will go up by about 7% in FY 2026 due to inflation and other financial adjustments. FDA also said in the notice this week that it met its FY 2024 hiring threshold, so it won’t be subject to a negative fee adjustment next year. The fee calculations do not take into account anything from FY 2025, the ongoing period that has included an extended hiring freeze, staff attrition from enhanced retirement incentives, and large-scale layoffs of, primarily, non-user fee staff (See “From MAHA to MDUFA? Walking a Tightrope in Trump-Era User Fee Talks,” Market Pathways, June 2, 2025). The Trump administration’s FY 2026 FDA budget request proposes to cut more than 400 device jobs, including about 200 user fee positions, which would flout FDA’s MDUFA V hiring commitments going forward.
