H.R. 9791: Nullifying Overbearing Federal Expenditures and Exorbitant Spending Act of 2026

This bill would change the Food and Drug Administration’s annual establishment registration fees for certain medical device companies.

What it would do

• It would expand and clarify the small business fee waiver for annual device establishment registration fees.
• For this purpose, a small business would mean an entity with fewer than 20 full-time equivalent employees, including employees of its affiliates.
• The FDA would be required to waive the annual registration fee for a business that qualifies as a small business, rather than treating the waiver as discretionary.
• The FDA could not deny the waiver simply because the business had paid the fee in prior years.
• To prove it qualifies, the business would have to submit a recent federal income tax return or payroll register at least 60 days before the fee is due.
• The bill would require the FDA to apply Small Business Administration rules on size and affiliation when deciding whether a business qualifies.
• Foreign-owned or foreign-organized entities would be barred from getting this small business waiver, and they could not create a U.S. entity just to try to qualify for it.
• If a business gets the waiver, it would cover the fee for 100% of the amount for the first 3 years, then 50% for the next 2 years.
• The waiver would stop sooner if the FDA determines the business is no longer a small business.
• The bill also changes the law to make the waiver decision non-reviewable, meaning the FDA’s waiver determination would not be subject to the same type of review process described in the prior text of the statute.

Foreign company fee increase

• The bill would make registration fees much higher for establishments owned or operated by entities organized under foreign government laws.
• For those foreign entities, the initial or annual registration fee would be set at eight times the normal fee.

When it would take effect

• The changes would start 90 days after the bill becomes law.

Relevant Companies

None found