119th (2025–2027)
H.R. 9791
The NO FEES Act of 2026 modifies federal requirements for medical device registration fees, particularly benefiting small domestic manufacturers. The bill redefines a small business as any company with fewer than 20 full-time equivalent employees across all affiliates and guarantees fee waivers for these small businesses for the first three years, followed by 50 percent fee reductions for the next two years. The legislation prohibits the FDA from considering payment history when deciding whether to grant waivers and explicitly bars foreign companies from claiming small business status or forming U.S. entities to access the waiver program. Additionally, the bill imposes an eightfold fee increase on foreign companies registering medical device establishments in the United States. The changes take effect 90 days after the bill is signed into law.