Medical Gadgets Get Pricier: FDA's 2026 Fee Update
Published Date: 7/30/2025
Notice
Summary
The FDA is setting new fees for medical device companies for the year starting October 1, 2025. These fees cover things like device submissions and annual registrations, with some discounts for small businesses. If you’re in the medical device world, get ready to pay updated fees and follow new payment rules in FY 2026.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Updated Medical Device User Fees
The FDA set new user fee rates for medical device submissions and annual establishment registrations that apply from October 1, 2025, through September 30, 2026. If you run or work for a medical device company, you will need to pay these updated fees during fiscal year 2026.
Small Business Fee Reductions Available
The notice says some companies may qualify for reduced small business fees for FY2026. The FDA provides information on how to qualify for reduced small business fees that apply during October 1, 2025, through September 30, 2026.
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