Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (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 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". The establishment registration fee is not eligible for a reduced small business fee.
The annual registration user fee for fiscal year 2020 follows:
| Year | FY 2020 |
|---|---|
| Fee |
$5,236 
|
Most establishments that are required to register with 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 premarket approval or notification before being marketed in the U.S., then the owner/operator should also provide the FDA premarket submission number (510(k), PMA, PDP, HDE, De Novo).
All registration and listing information must be submitted electronically, unless a waiverhas been granted.
Registration and listing provides 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 Registration and Listing Office 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)
Feedback Form
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.