On July 31, 2024, the U.S. Food and Drug Administration (FDA) officially announced in the Federal Register the new medical device and annual establishment registration fees for Fiscal Year 2025 (FY 2025), effective from October 1, 2024 to September 30, 2025.

Significant Increases by 2025

All fees show a significant increase compared to 2024.

In particular, the establishment registration fee rose to $9,280, up from $7,653 the previous year. As far as establishment registration is concerned, there are no exemptions or reductions for small enterprises or establishments.

Who Is Obliged to the Establishment Registration?

Owners and operators of establishments that manufacture and distribute Medical Devices for marketing in the United States are required to register annually with the FDA through a process known as ‘establishment registration’. Manufacturers and Initial Importers, in most cases, must also list the devices and the activities carried out on those devices at their facilities (“device listing“), as indicated in 21 CFR Part 807.

Further Fees

In addition to the establishment registration fee, FDA communicated the fees for other relevant applications, such as 510(k), 513(g), PMA, PDP, PMR, BLA and De Novo Classification Request, which are required to enter the US market. It is important to note that all 510(k) types are subject to payment, except those submitted through accredited third-party reviewers.

For these applications, small businesses benefit from reduced fees through CDRH’s Small Business Determination Programme, subject to certification.

>>> Thema and Thema Corp (US-based) provide strategic regulatory consultancy and assistance at every stage of the registration renewal and US market access process, ensuring efficiency and compliance.

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To consult all fees: FDA website

For information on the categories of devices obliged to register and how to proceed, you can consult this article on the FDA website.