Sponsor
Scott Perry
Representative · R-PA
Representative · R-PA
The bill increases clarity for tiny U.S. firms and shifts more registration costs onto establishments tied to foreign governments to encourage compliance and reduce taxpayer burden, but it narrows waiver eligibility and sharply raises fees for some foreign-linked businesses—raising costs for affected firms and consumers and adding administrative complexity for FDA.
Small U.S.-based businesses with fewer than 20 full-time employees get a clear, statutory definition of “small business,” making eligibility for FDA fee waivers more predictable and reducing uncertainty when applying for relief.
Consumers may face lower safety risk from certain low-cost foreign food or drug establishments because the bill raises registration fees for establishments organized under foreign governments, creating a financial incentive for higher compliance.
U.S. taxpayers could see a modest reduction in FDA subsidy burden because more registration costs are shifted onto covered foreign-government-organized establishments.
Imported-product businesses organized or owned by foreign governments will face much higher registration fees (about 8×), likely driving up costs, reducing market entry, and leading to higher prices for consumers of imported foods and drugs.
Small manufacturers and patients could face higher costs and slower access to new products because narrower waiver authority and added expiration constraints may reduce the number of FDA fee waivers granted for approvals.
Entities organized under foreign law are explicitly barred from waiver eligibility, preventing some startups or subsidiaries incorporated abroad from receiving fee relief and complicating financing or market-entry strategies for those firms.
Based on analysis of 4 sections of legislative text.
Raises FDA registration fees for establishments owned/operated by foreign‑law entities to 8× the base fee and narrows small‑business waiver eligibility to firms with <20 FTEs (affiliates counted).
Official title: To amend the Federal Food, Drug, and Cosmetic Act with respect to the requirements for the small business waiver from device fees related to annual establishment registration, and for other purposes.
Introduced July 20, 2026 by Scott Perry · Last progress July 20, 2026
Changes to the Federal Food, Drug, and Cosmetic Act raise registration fees for establishments owned or operated by entities organized under foreign law to eight times the base annual FDA registration fee and narrow who qualifies for a small-business fee waiver. The bill defines "small business" as fewer than 20 full‑time equivalent employees (including affiliates) and expressly excludes foreign‑organized entities from waiver eligibility. The revisions take effect 90 days after enactment and also update waiver and non‑reviewability language in the statute. The immediate practical effects are higher mandatory registration costs for foreign‑organized owners/operators of FDA‑regulated establishments and reduced waiver relief for many small firms and affiliates.