ARTICLE SUMMARY:
The US agency published its annual notice announcing fees it will charge device companies next fiscal year. Included in the report, an extra rise in facility registration fees stemming from performance gains FDA made prior to recent staffing cuts at the device center. FDA also issued an updated guide on small business discount and waiver requests.
FDA’s device user fee rates are on the rise but it’s unclear whether the extra funds will translate to performance improvements amid staff reductions at the device center.
It’s standard for the fees paid by device companies to increase annually. That’s part of the structure of the five-year MDUFA agreements, where fees go up in conjunction with the agency’s commitments to hire more reviewers and improve performance, on top of inflationary adjustments mandated by law. That framework explains the 7.1% increase in fees for all premarket submissions, including PMAs, De Novos, and 510(k)s, starting October 1, which FDA announced in its July 29 FY 2026 user fee rate notice (see Figure 1).
In addition to those standard elements, however, the current MDUFA V program includes new carrot-and-stick adjustments, where extra fee increases can result from FDA meeting certain performance thresholds and fees can be reduced if the agency lapses on certain commitments. For the second year in a row, FDA has qualified for a positive “performance improvement adjustment” to the fee that every company must pay annually to register each of its device facilities with the agency.
