Key information for medical device manufacturers
The US Food and Drug Administration (FDA) has opened the annual establishment registration renewal period for medical device companies marketing devices in the United States.
In this context, the FDA has also published updated medical device user fees for Fiscal Year (FY) 2027, effective from 1 October 2026 through 30 September 2027. The newly released schedule includes updates to the annual establishment registration fee and to the applicable fees for premarket application submissions, including 510(k)s, De Novo requests, and the Premarket Approval (PMA) pathway.
FDA establishment registration and device listing: annual renewal obligation
FDA establishment registration and device listing are fundamental regulatory requirements for companies involved in the manufacture and distribution of medical devices intended for the US market. These obligations apply to both US-based and foreign establishments.
Maintaining accurate registration and listing information is a fundamental element of compliance and market access in the US. Specifically, medical device establishment registration must be renewed annually for each fiscal year. The FDA renewal period runs from 1 October through 31 December each year, including establishments whose registration details have not changed.
The applicable annual registration fee must be paid before the renewal process can be completed. For FY 2027, the annual establishment registration fee has been set at USD 13.785 (thirteen thousand seven hundred and eighty-five US dollars).
Why timely renewal matters
Failure to complete annual renewal requirements and pay the applicable registration fee results in the establishment’s registration no longer being maintained as active in the FDA database. This can create significant regulatory and commercial challenges, including difficulties associated with importing, marketing, or distributing medical devices in the US.
Early preparation allows manufacturers to review their device listings, verify registration information, address potential compliance issues, and avoid last-minute delays before the 31 December renewal deadline.
How Obelis can help
Obelis USA LLC, appointed as US Agent and Official Correspondent, supports medical device manufacturers with FDA compliance requirements, including establishment registration and device listing, annual renewals, classification assessments, and pre-market submission preparation.
Whether you are entering the US market for the first time or looking for support in maintaining existing registrations, our team can help you navigate FDA requirements.
Giorgia Peotta
Regulatory Intelligence and Innovation Department
19/10/2026
References:
FDA. (2026). Medical Device User Fee Amendments (MDUFA): Fees. Retrieved on 19 October 2026.
FDA. (2025). Device Registration and Listing. Retrieved on 19 October 2026.
Obelis USA LLC. (2025). US Market Entry: Understand FDA Registration & Device Listing. Retrieved on 19 October 2026.
Obelis USA LLC. (2025). US Medical Device Market: FDA Classification & Premarket Pathways. Retrieved on 19 October 2026.
Obelis USA LLC. (2025). US FDA Agent & Official Correspondent. Retrieved on 19 October 2026.
The information contained on obelis.net is presented for general information purposes only, without obligation and it has been compiled with the utmost care to ensure it remains up to date. Nevertheless, Obelis Group cannot be held liable for the accuracy and completeness of the information published. Any reliance placed on such information is therefore strictly at the User’s risk.