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US FDA Establishment Registration for Medical Device Companies (FURLS)

Any establishment involved in the production, importation, or distribution of a medical device or IVD for commercial sale in the United States must register annually with the US Food and Drug Administration (FDA). This is called "Establishment Registration" and it is a separate process from obtaining 510(k) clearance or PMA approval.

Who needs to register with the FDA?

To determine if you need to register with the FDA, see our table that explains who must register and pay fees to the FDA. In short, if you manufacture a finished device, you must register.

Depending on the type(s) of activities you perform, FDA establishment registration also requires you to list the devices as well as activities performed related to each device at your firm. You must also register with the FDA if you are an initial importer and/or initial distributor with a US address taking first title to a device imported into the country. Again, please refer to the table we have prepared.

FDA Registration of your Company Using the FURLS System

Although you can complete the registration yourself using the FDA online FURLS system, some companies ask us to complete this for them as the process can be somewhat confusing. We encourage you to read about FDA Establishment Registration process on the FDA website here. If you read this page and still need assistance, we can certainly aid you in completing the process correctly as we have done for hundreds of medical device companies. We will:

  • Set up an account for you in the FURLS system, if your company is new to the US market
  • Facilitate payment of appropriate fees, which is necessary BEFORE the FDA registration process may proceed.
  • Complete the necessary information about your facility.
  • Register your device using the FDA Device Registration and Listing Module (DRLM)

If needed, we are also able to assist with assessing the classification and choosing the appropriate Product Code for your medical device, if you are registering a Class I product for the first time. In other cases, you should already have your 510(k) clearance letter before proceeding with FURLS registration.

Please contact us for more information on having Emergo complete your US FDA Establishment Registration.

Ask us for detailed information about USA FDA establishment registration services.

Learn about the process, costs and timelines.

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Frequently Asked Question:

Do I Need To Register With The US FDA?
This is not a simple yes or now question. Please see our table for more complete information.