NO FEES Act of 2026
- Sponsor
- Rep. Perry, Scott [R-PA-10]
- Committees
- Energy and Commerce Committee (primary)
- Last action
- Jul 20, 2026
Bottom line
The NO FEES Act of 2026 aims to reduce regulatory financial burdens on very small domestic medical device businesses while substantially increasing fees for foreign-owned establishments.
What it actually does
This bill significantly revises the small business waiver program for medical device annual establishment registration fees under the Federal Food, Drug, and Cosmetic Act. It redefines "small business" to include entities with fewer than 20 full-time equivalent employees, mandates waivers for qualifying businesses for up to five years, and prohibits the FDA from considering past payment history. Crucially, it excludes foreign companies from these waivers and imposes an annual registration fee on them that is eight times the standard amount.
Proponents argue
Proponents argue that the bill protects nascent domestic medical device innovators and small businesses from burdensome FDA fees, fostering growth and competition within the U.S. market. They contend that the current fee structure disproportionately impacts small entities, hindering their ability to bring new, potentially life-saving devices to market. The increased fees on foreign companies are presented as a way to level the playing field and ensure foreign entities contribute more significantly to the regulatory costs they impose.
Opponents contend
Opponents might argue that drastically reducing the definition of a "small business" to fewer than 20 employees could exclude many genuinely small and medium-sized enterprises that still struggle with fees. They may also contend that the eight-fold increase in fees for foreign companies could be seen as protectionist, potentially leading to retaliatory measures from other countries or reducing the availability of foreign-made medical devices in the U.S. market, which could impact patient access or increase costs.
The bill is short and relatively straightforward, making it accessible for a quick read to understand its core changes.
Section 2(a)(1), amending 21 U.S.C. 379j(a)(3)(B)(ii)(I)
Revised Small Business Definition for Fee Waivers
This provision changes the definition of a "small business" eligible for medical device establishment fee waivers. It narrows the definition significantly to an entity employing less than 20 full-time equivalent employees, including those of all its affiliates. This is a substantial reduction from previous definitions, which often used a 500-employee threshold for medical device user fees.
Supporters argue
Proponents argue this precise definition targets the smallest, most vulnerable startups and innovators, ensuring they receive the necessary financial relief to grow without being burdened by federal fees.
Critics contend
Critics might argue that this definition is too narrow, excluding many small and medium-sized medical device companies (e.g., those with 50-200 employees) that still face significant financial pressures and could benefit from fee waivers.
Tradeoffs
The tension lies between providing targeted relief to the smallest businesses and potentially excluding a broader range of small and medium-sized enterprises that also face regulatory costs.
Section 2(a)(2), amending 21 U.S.C. 379j(a)(3)(B)(ii)(II)
Mandatory Waiver Grant and Payment History Exclusion
This provision mandates that the Secretary of the FDA shall grant a fee waiver to any establishment found to be a small business under the new definition. It also explicitly prohibits the Secretary from considering an establishment's prior payment history when determining waiver eligibility, ensuring that past compliance or non-compliance with fees does not disqualify a currently eligible small business.
Section 2(a)(2), amending 21 U.S.C. 379j(a)(3)(B)(ii)(II)
Application of SBA Standards and Documentation for Waivers
This provision directs the FDA to use the Small Business Administration's (SBA) standards for size eligibility and affiliation (13 CFR 121.103 and 121.106) when determining if an establishment qualifies as a small business. It also specifies that establishments seeking a waiver must submit a copy of their most recent Federal income tax return or payroll register to the Secretary at least 60 days before the fee is due.
Section 2(a)(3), amending 21 U.S.C. 379j(a)(3)(B)(ii)(III)
Exclusion of Foreign Companies from Waivers
This provision explicitly states that entities organized under the laws of a foreign government cannot apply for a small business waiver. It also prohibits foreign entities from forming a U.S. entity solely for the purpose of applying for such a waiver, aiming to prevent circumvention of the exclusion.
Section 2(a)(4), amending 21 U.S.C. 379j(a)(3)(B)(ii)
Tiered Waiver Coverage and 5-Year Limit
This provision establishes a tiered waiver system: 100% of the fee is waived for the first three years an establishment qualifies, followed by a 50% waiver for the subsequent two years. After this five-year period, or if the establishment is no longer deemed a small business, eligibility for the waiver expires.
Section 3, adding 21 U.S.C. 379j(a)(3)(D)
Eight-Fold Fee Increase for Foreign Companies
This provision imposes a significantly higher annual registration fee on establishments owned or operated by entities organized under foreign government laws. Their fee will be eight times the standard fee required for domestic establishments.
The bill strikes the previous text of subclause (V) which detailed the process for requesting a waiver and inserted only "Non-reviewability.--". This could mean that the Secretary's decision on a waiver is not subject to judicial or administrative review, and it also removes the explicit 30-day deadline for requesting a waiver.
Section 2(a)(5), amending 21 U.S.C. 379j(a)(3)(B)(ii)(V)
Why it matters:This could be standard legislative shorthand, but the removal of the explicit deadline for waiver requests and the stark "Non-reviewability" statement could be seen as an attempt to streamline the process by limiting avenues for appeal or extending the application window indefinitely, which could be either beneficial or problematic depending on interpretation.
Case for: Supporters might argue that making waiver decisions non-reviewable streamlines the process, reduces litigation, and allows the FDA to efficiently implement the fee structure without undue delays. Removing the strict deadline could also provide more flexibility for small businesses.
Case against: Critics might argue that removing reviewability could lead to arbitrary decisions by the FDA without recourse for small businesses, undermining due process. The removal of a clear deadline could also create ambiguity for applicants.
Estimated impact: This provision could significantly impact the administrative process for waiver applications and the legal recourse available to businesses denied waivers.