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U.S. FDA Medical Devices Establishment Registration & Device Listing
Click the button below to see the service steps in an easy-to-follow graphic format.
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 US must register with the agency and pay an annual user fee of 9,280 USD (2025). Registered medical device establishments must also list all their medical devices individually through the Device Listing process before starting commercial distribution in the U.S. market. Medical devices cannot be cleared to enter the US market without a valid device listing number.
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. Device establishment registration must be renewed every year.
Third-party trading companies that purchase medical devices from foreign suppliers, referred to as foreign exporters, must register with the FDA and pay an annual fee. The foreign exporter registration will not exempt the original manufacturer of the medical device from registering and listing their products with the FDA. Additionally, companies that import medical devices into the U.S., known as initial importers, must register and pay the annual FDA fee.
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.
Information required & registration steps
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
The FDA Medical Device Establishment Registration Steps are:
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.
U.S. FDA Agent
Foreign companies must appoint a U.S. agent to be able to register with the FDA. The agent can serve as the primary contact with the FDA on behalf of a registered company. Simple mistakes during online registration can create critical adverse situations when the devices are at the U.S. port of entry. Therefore, it is crucial that the U.S. agent understands FDA regulations and can advise the company on FDA compliance requirements. Additionally, an independent FDA agent can prevent potential conflicts of interest when using a trade partner as an agent.
To clarify, the FDA neither approves nor disapproves US agent firms. During initial registrations, renewals, and updates to information about U.S. agents, the FDA will verify that the person or company identified as the U.S. agent for the foreign establishment has agreed to serve as the agent.
FDA Registration Certificate
Although the FDA does not issue certificates, upon completion of registration, FDA Listing Inc. will provide a valid registration certificate for the current year that can be used as proof of registration. A copy of the certificate can also be used to confirm registration with U.S. customs, importers, distributors, and other commercial outlets. Please call or email us if you need medical device establishment registration assistance.
Service Details & Fees
Device Establishment Registration
Time Required
U.S. Agent
Device Listing (5 Classes)
FDA Registration Certificate
545 USD
3-5 Days
_______ Related Services _______
Frequently Asked Questions (FAQ)
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).
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).
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).
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).
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).
Frequently Asked Questions (FAQ)
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).
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).
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).
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 _______