Frequently Asked Questions:
Do I Need To Register With The US FDA?
This is not a simple yes or no question. Please see our table for more complete information.
ANSWERED ON THIS PAGE:
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.
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.
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:
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.
Do I Need To Register With The US FDA?
This is not a simple yes or no question. Please see our table for more complete information.