21 CFR 807.40

FDA U.S. Agent for medical device establishments in Italy

A medical device establishment in Italy that exports to the United States must register with FDA and name a U.S. Agent located in the U.S. (21 CFR 807.40). In the 12 months from 2025-10 to 2026-09, FDA refused 273 import lines from Italy, and 38 FDA import alerts list firms from Italy.

FDA data for Italy

Figures from FDA public data, retrieved 2026-10-21. Recall counts are by the recalling firm's country.

Import refusals, 2025-10 to 2026-09

Refused import lines	273
Refusals citing registration or listing problems	NOT LISTED-118 · 76 FRNMFGREG-3280 · 61

Most refused product industries

Code		Count
79	General & Plastic Surgery	27
86	Ophthalmic	15

Most common refusal charges

Code	Count
NOT LISTED-118 The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. Based on the information…	76
UNSAFE COL-11 The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).	74
FRNMFGREG-3280 The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. Based on information available to FDA, i…	61
UNAPPROVED-75 The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).	44
NO 510(K)-508 The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantial…	20

Import alerts listing Italy firms

Import alerts that list at least one firm in Italy: 38. Recently updated:

Import Alert 89-04: Detention Without Physical Examination of Devices from Firms that Have not met Device Quality System Requirements

Recalls by Italy firms, last 5 years

29 (Class II: 29)

Recent recall reasons:

2026-10 Due to blood-to-glycol leak in the heat exchanger.
2026-08 Due to a software issue within the WebApp that potentially prevents the user to overwrite the results.
2026-06 Natus has become aware of two complaints related to the SD LTM 64 PLUS where the EEG traces acquired from two or four different amplifiers used in a multiple a…

What the rule requires

Every foreign establishment that manufactures, prepares, propagates, compounds or processes a medical device imported into the United States must register with FDA, list its devices, and designate a single U.S. Agent. Registration is renewed every year between October 1 and December 31, and FDA's annual establishment fee must be paid first.

Foreign manufacturers, contract manufacturers, contract sterilizers, specification developers, repackagers, relabelers and some kit assemblers of devices exported to the U.S.
Initial importers in the U.S. register separately; they do not need a U.S. Agent

Deadlines

Register within 30 days of beginning an operation that requires registration
Renew annually between October 1 and December 31 (21 CFR 807.22)
Pay the annual establishment registration user fee before submitting

Steps

Pay FDA's annual establishment registration fee through the Device Facility User Fee website and get a Payment Identification Number
Create an account in FDA's FURLS Device Registration and Listing Module (DRLM)
Your official correspondent enters the establishment, owner/operator, U.S. Agent and device listings
FDA emails the U.S. Agent to confirm the designation
Keep your FEI and owner/operator number on file

Common mistakes

Paying the user fee but never completing the registration in DRLM
Naming a U.S. Agent who has not agreed. The agent must confirm in FDA's system
Forgetting to list each device under the correct product code
Believing that registration means FDA has cleared or approved the device. It does not

How US Agent Desk helps

We serve as your U.S. Agent, prepare the registration data in your language for your company's officer to submit, confirm the designation when FDA asks, and check FDA's public records for your company every morning. Prices start at $990 per year.

Check if you need a U.S. Agent See prices

Sources

Independent private service. Not affiliated with the U.S. FDA. Not legal advice.