ARTICLE SUMMARY:
FDA’s FY 2026 budget proposal would increase device funding but cut staff, including user fee-supported employees; Excerpted from Pathways’ Picks June 4: FDA Cuts, AI Tool, 510(k) Guide, Mexico Streamlines, and More.
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.
Notably, devices are the only FDA medical products program tapped in the budget request for more money next year. In comparison, FDA’s larger drug program would be subject to a $60 million budget cut and lose more than 1,000 FTEs (including more than 800 user fee FTEs). The apparent reason devices were targeted for an increase was to reach the statutorily required amount of congressional money needed to allow FDA to continue to collect user fees (from provisions designed to ensure industry doesn’t need to foot the full bill). This suggests that the device budget has significantly less wiggle room in meeting the user fee minimum thresholds compared to other FDA programs, which have similar statutory triggers in place. In total, FDA funding would drop by $271.5 million (down 3.9% to $6.8 billion) in FY 2026, including a $137 million increase in user fees counterbalanced by a $400 million-plus reduction in requested congressional appropriations. Congress typically passes a much different budget compared to what is requested by presidential administrations. However, it is worth noting that significant elements of the FDA request reflect consolidations and cuts that HHS has already carried out in its April 1 reductions in force (RIFs) and restructuring (courts have blocked HHS from finalizing the RIFs, but most impacted CDRH staff remain on administrative leave).