U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Device Advice: Comprehensive Regulatory Assistance
  4. How to Study and Market Your Device
  5. Device Registration and Listing
  1. How to Study and Market Your Device

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." 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

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 has been granted.

Registration and listing provide 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:


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.

* indicates required field

*Is this an initial registration or are you updating an existing registration or listing?
*Please enter a brief summary of the issue you encountered. If you are seeing an error message while in the registration website, please identify what the error message said and the action you were attempting at the time.

Sub-Topic Paragraphs

Paragraph Header
Contact Us

Subscribe to CDRH Industry

Receive email updates for new or updated content that is specifically related to industry.

Back to Top