ANSWERED ON THIS PAGE:
- What is the medical device US FDA Establishment Registration?
- Are we required to obtain an Establishment Registration with the FDA?
- How do we complete our Establishment Registration?
Any establishment involved in the production, importation, reprocessing/relabeling, or developing specifications 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 explaining who must register and pay fees to the FDA. As a general rule, if you manufacture all or part of a medical device sold in the US, or perform processing (e.g., sterilization) on the device, you must register.
With the exception of Initial Importer, FDA also requires registered establishments to list the devices. An initial importer who is responsible for furthering the marketing of a device entering the US from a foreign manufacturer to the final distributor for sale of the device to the ultimate consumer or user must register their establishment, but is not required to list the devices. Again, please refer to the table we have prepared.
FDA Establishment Registration of your company in the FURLS database
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 help you complete 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 details about your facility with the information you provide.
- List your device using the FDA Device Registration and Listing Module (DRLM)
If needed, we can also 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, which contains the product code and other regulatory information before proceeding with FURLS registration.