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U.S. FDA Registration
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U.S. FDA Medical Devices Establishment Registration & Device Listing
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Who must Register with the FDA?
Medical device companies involved in manufacturing, packaging, labeling, assembling, importing, exporting, or distributing devices for the U.S. market are required to complete FDA medical device establishment registration and device listing. These requirements apply to both U.S. and foreign establishments, depending on the activities they perform. In addition, the registered establishments are required to pay an Annual FDA Establishment Registration Fee of 13,785 USD for FY 20267.
Third-party trading companies that export medical devices to the United States as ‘foreign exporters’ must register with FDA, list applicable devices, and pay the annual registration fee. Regardless of whether a foreign exporter is registered, all applicable parties—including the foreign manufacturer and the U.S. initial importer—must also register, list applicable devices, and pay the annual fee. FDA establishment registration and device listing must be renewed annually between October 1 and December 31 to remain current.
An FDA device listing number is a unique identifier generated in FDA’s Device Registration and Listing Module for a successfully created device listing. It identifies the listed device record associated with a specific establishment, but it does not mean the device is FDA-approved.
Related Blog Article: Who Must Register and Pay the FDA Fee
Role of U.S. FDA Agent & Official Correspondent
In addition to FDA establishment registration and device listing, all foreign medical device establishments must appoint a U.S. Agent as the FDA’s primary point of contact. The owner or operator of each medical device establishment, whether domestic or foreign, must also designate an official correspondent. These contacts serve as the FDA’s primary points of contact for communications regarding inspections, registration renewals, and regulatory requirements affecting the establishment.
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?
FDA registration is generally completed within 4–5 business days, provided all required information is complete and accurate, including the facility’s DUNS number. Delays may occur if required information is missing, inconsistent, or requires additional verification.
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
Important Note: 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 ?
Following FDA registration, there is typically a waiting period before the establishment is assigned an FEI (FDA Establishment Identifier) number. During this period, the Owner/Operator Number (O/O Number) may be used for shipment clearance and other FDA compliance purposes. Companies must also promptly update their FDA records whenever there are changes to their establishment or product information.
What is the Role of U.S. FDA Agent ?
Foreign companies must designate a U.S. Agent when registering with FDA. The U.S. Agent serves as the primary liaison between FDA and the company and helps ensure regulatory requirements are properly addressed. Errors or inconsistencies in the registration can lead to delays or compliance issues, including at U.S. ports of entry.
Therefore, the U.S. Agent should have a strong understanding of FDA requirements and be able to guide the company through medical device establishment registration and device listing. Using an independent FDA U.S. Agent can also help avoid potential conflicts of interest when a trade partner or distributor serves in this role.
It is important to note that the FDA does not approve or endorse U.S. Agent firms. During initial registration, renewals, or updates, the FDA verifies that the designated U.S. Agent has agreed to represent the foreign establishment.
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
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)
Who must register a medical device facility with the FDA?
Any domestic or foreign company that manufactures, processes, package-labels, contract-manufactures, or imports medical devices for U.S. distribution must complete annual establishment registration.
What is the difference between device establishment registration and device listing?
Establishment Registration: Identifies the physical manufacturing, processing, or importing facility.
Device Listing: Identifies the specific medical devices, proprietary brand names, product codes, and premarket submission numbers tied to that facility.
Does having an FDA registration or listing number mean a medical device is "FDA Approved"?
No, establishment registration and device listing simply notify the FDA of your facility and product line. It does not imply FDA approval, clearance, or safety endorsement.
Do foreign medical device establishments need a U.S. Agent?
Yes, foreign device manufacturers and exporters must designate a U.S. Agent located physically in the United States to handle official FDA communications, emergency inquiries, and inspection schedules.
Is premarket clearance required before listing a medical device?
If your device requires premarket notification, such as in most Class II devices, you must obtain a clearance number via 510K approval before submitting your device listing. Exempt Class I and Class II devices only require the assigned FDA product code.
When must FDA medical device establishment registrations be renewed?
Facility registrations and device listings must be renewed annually between October 1 and December 31, alongside payment of the mandatory annual establishment user fee.
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 _______