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News: Device Registration and Listing

Article Date(s):04/17/2020

Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (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 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". The establishment registration fee is not eligible for a reduced small business fee.

The annual registration user fee for fiscal year 2020 follows:

Year FY 2020
Fee $5,236

Most establishments that are required to register with 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 premarket approval or notification before being marketed in the U.S., then the owner/operator should also provide the FDA premarket submission number (510(k), PMA, PDP, HDE, De Novo).

All registration and listing information must be submitted electronically, unless a waiver has been granted.

Registration and listing provides 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.

The FDA has contracted the services of Dun & Bradstreet to conduct onsite verification of medical device facility information provided to the agency by registered and listed medical device manufacturers. As part of these services, Dun & Bradstreet may look to verify information such as a facility’s Data Universal Numbering System (DUNS)External Link Disclaimer disclaimer icon, various addresses, establishment type, and products.

Dun & Bradstreet may also contact firms not registered with the FDA that the agency has learned may be involved in the manufacture of medical devices.

Participation is voluntary—if Dun & Bradstreet contacts your facility, we ask for your full cooperation so that we can verify your facility’s information is accurate. By cooperating with these efforts, you help us save you time and expense.

If you are contacted and you want to confirm the legitimacy of the verification request, please ask to see the requestor’s Dun & Bradstreet identification.