On 5 October, FDA published the Medical Device User Fee Amendments (MDUFA), a document containing updates on the registration fees for marketing Medical Devices in the United States.

With regard to the Establishment Registration, the annual registration fee for 2023 is $6,493 – $821 more than in 2022, an increase of 14%. There are no exemptions or reductions for smaller companies.

Establishment Registration applies to all establishments of organisations involved in the manufacture and marketing of devices that are based in the US or outside the US in order to still be able to market in the territory.

See below the fees to be paid to FDA from 1 October 2022 to 30 September 2023 for different applications:











* Small Business: companies recognised by the Center for Devices and Radiological Health (CDRH) as small businesses, therefore characterised by $100 million or less in revenue or gross sales/year.

** Pre-market Notification (PMN) or 510(k) procedure: the fee applies to all types of 510(k) (traditional, abbreviated and special).

>> How can we help you to market your devices in the U.S.?

With strategic-regulatory consulting and registration support services in the U.S., including the 510(k) Procedure, Thema can support you in complying with all pre- and post-market requirements of 21 CFR and federal regulations, allowing for smooth and efficient device entry and distribution.

In addition, with our Local Representative, U.S. Agent and U.S. Initial Importer services, which are mandatory for Establishment Registration, you can market your devices with total independence and autonomy.

Contact our Customer Service for information!