U.S. FDA Medical Devices Establishment Registration & Device Listing

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Who must Register with the FDA?

According to the U.S. FDA, all medical device establishments that develop, manufacture, pack, assemble, label, export, or import medical devices into the United States are required to register with the FDA and pay an annual user fee of $11,423 (FY 2026). Additionally, registered establishments must list each of their medical devices individually through the FDA Device Listing process before distributing them commercially in the U.S. market. Without a valid establishment registration and device listing number, medical devices cannot be legally marketed in the United States.

Furthermore, third-party trading companies that purchase medical devices from foreign suppliers—commonly referred to as foreign exporters—are also required to register with the FDA and pay the annual fee. However, this registration does not exempt the original manufacturer from registering and listing its devices with the FDA. Similarly, companies that import medical devices into the U.S., known as initial importers, must complete FDA registration and pay the applicable annual fee. It is essential to note that FDA medical device establishment registration and device listing must be renewed annually to remain valid.

Role of U.S. FDA Agent & Official Correspondent

In addition to device establishment registration and listing, all medical device firms outside the U.S. must appoint a U.S. agent as the FDA’s primary point of contact. The owner or operator of a medical device establishment, whether domestic or foreign, must also appoint an official correspondent for the company. These contacts serve as the FDA’s primary contacts for communications regarding inspections, registration renewals, or the publication of any requirements affecting the facility.

Related Blog Article: Who Must Register and Pay the FDA Fee

What is FDA Device Classification?

Companies must classify medical devices for proper listing as part of device establishment registration. The FDA categorizes medical devices into three classes: Class I, Class II, and Class III, based on the associated risks, with Class III representing the highest risk. The FDA Device Classification Database contains device names, technical descriptions, and related product codes that identify a device’s generic category for the FDA.

Upon registration, medical device establishment registration information becomes available on the FDA Device Establishment Database, yet a specific part of information known as the device listing number will remain private. This is because the FDA aims to honor medical device establishments’ sovereignty and exclusivity rights over the import and marketing of their products.

What Information is Required for Device Registration?

When applying for a medical device registration number, the following information is required:

● DUNS number and Tax ID/EIN (only for US firms)
● Establishment name, address, and official correspondent
● Information on the owner, operator, or agent in charge
● Device classification and types of activities conducted
● List of trade names (brand names)
●U.S. Agent who has accepted the designation

What are the FDA Medical Device Registration Steps?

1- Obtaining a DUNS number via the D&B portal or partner office
2- Verification of facility information and device classification codes
3- FDA submission, obtaining Owner/Operator and device listing numbers
4- Issuing the Certificate of registration by a third-party agent

The FDA registration is generally completed within 4-5 days if all information, including the facility DUNS number, is adequately provided.

As of September 2022, manufacturers and labelers of all device classes I, II, and III sold in the U.S. must submit their device information to the FDA’s Global Unique Device Identification Database (GUDID) and obtain the UDI to be printed on their device labels.

What happens after FDA Device Registration ?

After FDA registration, there is a waiting period before your device establishment is assigned an FEI (FDA Establishment Identifier) number. During this period, the Owner/Operator Number (O/O Number) will be used for shipment clearance and other compliance purposes. Post-FDA registration, companies are also required to immediately update FDA records if there are any changes to their establishment or product information.

What is the Role of U.S. FDA Agent ?

Foreign companies must designate a U.S. agent to register with the FDA. This agent acts as the main liaison between the FDA and the company, ensuring regulatory requirements are properly handled. Even minor errors during online registration can cause delays or compliance issues at U.S. ports of entry. Therefore, it is essential that the agent is knowledgeable about FDA regulations and can guide the company on medical device establishment registration and device listing. Using an independent FDA agent also helps avoid conflicts of interest that could arise if a trade partner serves in this role.

It is essential to note that the FDA neither approves nor endorses U.S. agent firms. During initial registration, renewals, or updates, the FDA verifies that the designated U.S. agent for the foreign establishment has agreed to serve in this role.

FDA Registration Certificate

Although the FDA does not issue certificates, FDA Listing Inc. provides a registration certificate for the current year upon completion of the registration process. This certificate serves as proof of registration and can be shared with U.S. Customs, importers, distributors, and other commercial partners.

How can FDA Listing Inc Assist?

Compliance with FDA medical device establishment registration requirements can be complex and time-consuming, and often requires expert knowledge. FDA Listing Inc. simplifies compliance with FDA regulations, helping your firm meet registration and listing obligations in the following ways:

Assistance with medical device establishment registration
Assistance with medical device listing and data submission
Serving as a U.S. Agent for foreign establishments
Guidance on official correspondent designation

Please email or call us if you need assistance with establishment registration, device listing, U.S. agent services, or any FDA medical device compliance matter.

Service Details & Fees

545 USD

3-5 Days

_______ Related Services _______

Frequently Asked Questions (FAQ)

Do I need to keep the FDA Food Facility registration number in all communications and invoice?

U.S. FDA requires ﬁlling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After ﬁlling the Prior Notice, you will be assigned with a conﬁrmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be ﬁled by your own compnay or international transit ﬁrms as well as shipment companies (DHL, FedEx, TNT, etc).

Do I need to keep the FDA Food Facility registration number in all communications and invoice?

Frequently Asked Questions (FAQ)

Service Details & Fees

Device Establishment Registration

545 USD

Time Required

3-5 Days

U.S. Agent

Device Listing (5 Classes)

FDA Registration Certificate

_______ Related Services _______

U.S. FDA Registration

& Labeling Compliance Assistance

U.S. FDA Medical Devices Establishment Registration & Device Listing

Who must Register with the FDA?

Role of U.S. FDA Agent & Official Correspondent

What is FDA Device Classification?

What Information is Required for Device Registration?

What are the FDA Medical Device Registration Steps?

What happens after FDA Device Registration ?

What is the Role of U.S. FDA Agent ?

FDA Registration Certificate

How can FDA Listing Inc Assist?