Owners or operators of establishments that are involved in the production and distribution of medical devices intended for use in the U.S. are required to register annually with the FDA. This process is known as establishment registration (Title 21 CFR Part 807).
Congress has authorized the FDA to collect an annual establishment registration fee for device establishments. A detailed list of the types of device establishments that are required to register and pay the fee can be found at “Who Must Register, List and Pay the Fee.” There are no waivers or reductions for small establishments, businesses, or groups.
The annual registration user fee for fiscal year 2024 follows:
| Year | Fee |
|---|---|
| FY 2024 (October 1, 2023-September 30, 2024) | $7,653 |
The annual registration user fee for fiscal year 2025 follows:
| Year | Fee |
|---|---|
| FY 2025 (October 1, 2024-September 30, 2025) | $9,280 |
Generally, establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. If a device requires a premarket submission before being marketed in the U.S., then the owner/operator should also provide the FDA premarket submission number (510(k), De Novo, PMA, PDP, HDE).
Registration and listing provides the FDA with the location of medical device establishments and the devices manufactured at those establishments. Knowing where devices are made increases the nation's ability to prepare for and respond to public health emergencies.
For assistance with registration and listing status, please contact the CDRH Registration and Listing Help Desk at:
For assistance with policy or detention issues, please contact the Registration and Listing Staff at:
If you encounter an issue during the registration and listing process and need to contact us, please fill out as much of the information below as possible.
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