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 In this section:

        How to Study and Market Your Device

Device Registration and Listing

                        
                Important Reminders about Registration and Listing
          Access Electronic Registration
          Who Must Register, List and Pay the Fee
          When to Register and List
          How to Register and List
          Payment Process
          U.S. Agents
          FDA Onsite Registration and Listing Verifications
          Frequently Asked Questions about the New Device Registration and Listing Requirements
          Search Registration and Listing Home
          Medical Devices
          Device Advice: Comprehensive Regulatory Assistance
          How to Study and Market Your Device
          Device Registration and ListingHow to Study and Market Your Device Device Registration and Listing
  	
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    PrintOwners 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:

Phone: 301-796-7400
	Email: reglist@cdrh.fda.govFor assistance with policy or detention issues, please contact the Registration and Listing Staff at:

Phone: 301-796-7400
	Email: device.reg@fda.hhs.govTutorials

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.

** indicates required field*

*Name:

Business Name:

*Email Address:

Phone Number:

Best Time to Reach You (please include your time zone):

Establishment Registration Number (unless one is not assigned):
***Is this an initial registration or are you updating an existing registration or listing?**

Initial Registration

Updating Existing

*Business Name of Your Establishment:

Address of Establishment: Address

Owner/Operator Number for the Establishment:

Payment Identification Number (PIN):

Payment Confirmation Number (PCN):

DUNS Number:

***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.** Summary
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                                                                                  Content current as of:
      11/29/2023
                  
                   
Regulated Product(s)
		 Medical Devices
			  			     			  			     Radiation-Emitting ProductsDevice Registration and Listing                
                          

                        Important Reminders about Registration and Listing
          Access Electronic Registration
          Who Must Register, List and Pay the Fee
          When to Register and List
          How to Register and List
          Payment Process
          U.S. Agents
          FDA Onsite Registration and Listing Verifications
          Frequently Asked Questions about the New Device Registration and Listing Requirements
          Search Registration and Listing
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