ARTICLE SUMMARY:
In this week’s Pathways Picks: FDA’s FY 2026 budget proposal would increase device funding but cut staff, including user fee-supported employees; Small Business Determination backlog; the agency launches an AI tool to improve efficiency; FDA accepts court’s ruling on LDTs; 510(k) ownership transfer guide; EU updates; Mexico cuts burdens for devices; inaugural African Medicines Agency chief; and more from the US, South Korea, and Singapore.
FDA Picks
Budget request, AI tool, 510(k) guide, and more:
FDA requests user fee staff cut. FDA’s device program would see an increase of more than $41 million next fiscal year under the Trump administration’s FY 2026 budget request (up 5% to $883 million), including $8 million in extra money appropriated from Congress and $33 million more in industry user fees. But the program (including CDRH and field activities) would still be slated to lose more than 400 full-time equivalents (FTEs), including cutting 201 employees funded by industry fees. The cut in user fee staff is notable considering the influx in planned fee dollars and that CDRH committed to hiring more reviewers and scientists in FY 2026 under the MDUFA V agreement with industry. The details were provided in budget tables FDA posted online May 30. The request reflects priorities under President Trump and HHS Secretary Robert F. Kennedy Jr., but it is Congress that ultimately sets and approves the appropriations to federal agencies.
