Importing medical devices into the US: FDA registration, listing and 510(k)

Medical devices imported into the US are reviewed by FDA as part of the customs entry. The foreign manufacturer must register its establishment, list its devices, name a US agent and, unless the device is exempt, have a 510(k) clearance or PMA approval. The initial importer also registers, and the entry must carry codes that match FDA's records, or the shipment may be detained.

Checked against official sources: 2026-10

At a glance

Who registersForeign manufacturers and foreign exporters register and list devices; initial importers register but do not list devices

Annual registrationEvery year between 1 October and 31 December; new establishments within 30 days of beginning an activity

Registration feeUSD 13,785 for FY 2027 (1 October 2026 to 30 September 2027), paid before registration is completed

US agentRequired for foreign establishments; must live or have a place of business in the US (no post office box or answering service only)

Premarket routeMost Class I devices are exempt from 510(k); most Class II need a 510(k); most Class III need PMA

510(k) fee (FY 2027)USD 28,653 standard, USD 7,163 for a qualified small business

Quality systemQuality Management System Regulation (QMSR), effective 2 February 2026

Entry codesDEV or DFE registration, LST listing number and PM# premarket number, sent with the entry through ACE

How FDA reviews a device import

Entries filed with US Customs and Border Protection (CBP) are also sent electronically to FDA through ACE. For devices the entry gives the country of origin, FDA product code, importer's product description, manufacturer, shipper, affirmation of compliance codes and HTS code. FDA compares these with its registration and listing records, and products that do not meet FDA requirements may be detained on entry.

The basic requirements for a foreign manufacturer are establishment registration, device listing, a quality management system, a 510(k) or PMA unless exempt, labeling, and medical device reporting (MDR). The initial importer, who furthers the marketing of a device without repackaging or relabeling it, registers its establishment, reports adverse events under 21 CFR 803, reports corrections and removals under 21 CFR 806 and follows device tracking under 21 CFR 821 where it applies.

Affirmation of compliance codes for devices

DEV: registration number of the foreign device manufacturer
DFE: registration number of the foreign device exporter, if different from the manufacturer
LST: device listing number of the manufacturer or foreign exporter
PM#: 510(k) or PMA number, when the FDA product code requires one
DDM: domestic device manufacturer, for some US goods returned, import for export, reprocessing and device kits
The FDA product code, manufacturer, shipper and premarket number must match what is on the listing

Registration, fees and the US agent

Registration is done in FDA's Unified Registration and Listing System (FURLS) and renewed every year between 1 October and 31 December. All establishments that must register pay the annual registration fee before the registration is completed: USD 13,785 for FY 2027. FDA may waive the annual fee, but not the initial one, for some qualified small businesses that show financial hardship.

A foreign establishment names one US agent in its registration. The agent must live or have a place of business in the US, cannot use only a post office box or an answering service, and confirms by email; if it does not confirm within 10 business days, the establishment must name another. The agent helps FDA communicate with the establishment and schedule inspections, but is not responsible for MDR reports or 510(k) submissions. Importers of radiation-emitting products under a performance standard also file Form FDA 2877.

Step by step

Find the device's FDA product code and class, and whether it needs a 510(k), a PMA or is exempt.
Get the 510(k) clearance or PMA approval before shipping, if one is required.
Pay the annual registration fee, register the establishment in FURLS, list the devices and name a US agent.
Make sure the initial importer has registered and identifies the manufacturers it imports from.
Give the customs broker the DEV or DFE, LST and PM# numbers, product code and HTS code for the ACE entry.

Documents you usually need

Establishment registration number (DEV for the manufacturer, DFE for a foreign exporter)
Device listing number (LST)
510(k) or PMA number (PM#), unless the device is exempt
FDA product code and HTS code on the commercial invoice
Form FDA 2877, for radiation-emitting products subject to a performance standard

Common problems and how to avoid them

FDA reports "LST not transmitted" or cannot find the listing number.

What to do: Send the manufacturer's or foreign exporter's listing number with the entry and check it is correct and current.

The DEV or DFE does not match the manufacturer and shipper on the entry line.

What to do: Use the registration numbers of the firms actually named as manufacturer and shipper on that line.

The product code needs a premarket number but no PM# was sent.

What to do: Add the 510(k) or PMA number; if the device is exempt, check that the product code is the right one.

The product code or premarket number does not match the device listing.

What to do: Declare the product code and premarket number exactly as they appear on the listing, or update the listing in FURLS.

Sources

Importing Medical Devices and Radiation-Emitting Electronic Products into the U.S. U.S. Food and Drug Administration (FDA)
Who Must Register, List and Pay the Fee U.S. Food and Drug Administration (FDA)
When to Register and List U.S. Food and Drug Administration (FDA)
U.S. Agents U.S. Food and Drug Administration (FDA)
Medical Device User Fee Amendments (MDUFA): Fees U.S. Food and Drug Administration (FDA)
Overview of Device Regulation U.S. Food and Drug Administration (FDA)
Medical Device Common Entry Errors U.S. Food and Drug Administration (FDA)

Rules change often. This note is practical guidance based on the sources above, not legal advice. Confirm current requirements with the authority, your importer or a licensed customs broker before you ship.

Port codes by country

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Trade notes

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Common questions

Does a foreign company need FDA registration to export medical devices to the US?

Yes. Foreign manufacturers and foreign exporters register their establishment, list their devices and name a US agent; the initial importer also registers.

How much is the FDA medical device registration fee?

USD 13,785 for FY 2027, which runs from 1 October 2026 to 30 September 2027. It is paid before the registration is completed.

When must device registration be renewed?

Every year between 1 October and 31 December. A new establishment registers within 30 days of beginning an activity.

Do all medical devices need a 510(k)?

No. Most Class I devices are exempt, most Class II devices need a 510(k), and most Class III devices need a PMA.

What does the US agent do?

It helps FDA communicate with the foreign establishment, answers questions about its imported devices and helps schedule inspections. It is not responsible for MDR reports or 510(k) submissions.

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