FDA 510(k) Consulting, FDA 510(k) Consultant

MEDICAL DEVICE ESTABLISHMENT REGISTRATION AND DEVICE LISTING

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) and pay an annual licensing fee. This is called "Establishment Registration" and it is a separate process from obtaining 510(k) clearance or PMA approval.In addition, the company must list all medical devices to be marketed in the United States. We can help you register your establishment with FDA and list all your devices on FDA’s FURLS database for a fee or handle this service at no charge after clearing your 510(k) from FDA.

WHO NEEDS TO REGISTER WITH THE FDA?

The medical device company must register with the FDA 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 are not required to list the devices.

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. If you need assistance FDA Establishment Registration process, we can certainly help you complete the process correctly, as we have done for several 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.