FDA annual establishment registration renewal for 2027: requirements and updated fees

The US Food and Drug Administration (FDA) has opened the annual establishment registration renewal period for medical device companies marketing their devices in the United States. In this context, the FDA has also published the updated user fees for Fiscal Year (FY) 2027, effective from 1 October 2026 through 30 September 2027. 

What is FDA annual establishment registration? 

Under Part 807 of Title 21 of the US Code of Federal Regulations owners and operators of establishments involved in the manufacture and distribution of medical devices intended to be placed on the US market must register their establishment and list their devices with the FDA.  

This process is an administrative and regulatory obligation designed to ensure the identification of medical device establishments and their activities on the US market, supporting related FDA oversight. This obligation applies to both US-based and foreign establishments.

Annual renewal requirements and updates fees for FY 2027 

Establishment registration is not a one-time obligation. The FDA requires medical device establishments to renew their registration and device listing information annually for each fiscal year. The renewal window runs from 1 October to 31 December each year, regardless of whether any changes have occurred to the establishment or listed devices.  

An annual registration fee must be paid before the registration renewal can be completed. For FY 2027, the annual establishment registration fee has been set at USD 13.785.

Impact on medical device establishments

Failure to pay the annual registration fee and complete the annual renewal process results in the establishment’s registration no longer being maintained as active in the FDA database. This can lead to significant regulatory and commercial challenges, including difficulties associated with importing, marketing, or distributing medical devices in the US. 

Medical device establishments should therefore review their registration and listing information in a timely manner and ensure that their annual renewal is completed before 31 December 2026. 

Contact MDlaw for assistance with FDA establishment registrations: here or at mdlaw@obelis.net.

References:

FDA. (2026). Medical Device User Fee Amendments (MDUFA): Fees. Retrieved on 19 October 2026.

eCFR.(2026). 21 CFR Part 807 – Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices. Retrieved on 19 October 2026.