Device Registration and Listing
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.”
Generally, for FY 2025, there are no MDUFA Establishment Registration Fee waivers or reductions for small businesses.
For FY 2026, the FDA may grant a waiver of the annual establishment registration fee (excluding the initial registration) to certain small businesses certified through the Small Business Determination (SBD) Program who demonstrate paying the fee represents financial hardship as determined by the FDA. For more information, see the section Small Businesses below.
The annual registration user fee for fiscal years 2025 and 2026 follows:
| Year | Fee |
|---|---|
| FY 2025 (October 1, 2024-September 30, 2025) | $9,280 |
| FY 2026 (October 1, 2025-September 30, 2026) | $11,423 |
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).
All registration and listing information must be submitted electronically, unless a waiver from submitting electronically has been granted.
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:
- Phone: 301-796-7400
- Email: reglist@cdrh.fda.gov
For assistance with policy or detention issues, please contact the Registration and Listing Staff at:
- Phone: 301-796-7400
- Email: device.reg@fda.hhs.gov
Tutorials
- CDRH Learn with Device Registration and Listing
- CDRH Learn Course: Paying the Annual Registration User Fee via the Device Facility User Fee (DFUF) Website
- CDRH Learn Course: FURLS Device Registration and Listing Module for Initial Registration
- CDRH Learn Course: FURLS Device Registration and Listing Module for Annual Registration (PDF - 811KB)
Small Businesses
Certain small businesses certified through the SBD program may qualify for a waiver for the registration fee if the business and its affiliates have gross receipts and sales of no more than $1 million, can demonstrate paying the registration fee would represent a financial hardship (for example, proof the business is in active bankruptcy), and has proof of a prior year’s payment of the registration fee.
For program qualification and details on submitting a Small Business Request, see Reduced Medical Device User Fees: Small Business Determination (SBD) Program.
Feedback
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