21 CFR 807.40

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

A medical device establishment in Israel 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 65 import lines from Israel, and 21 FDA import alerts list firms from Israel.

FDA data for Israel

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	65
Refusals citing registration or listing problems	NOT LISTED-118 · 13 FRNMFGREG-3280 · 12 REGISTERED-341 · 8

Most refused product industries

Code		Count
76	Dental	5
95	Light Emitting Non-Device Products	5
79	General & Plastic Surgery	4

Most common refusal charges

Code	Count
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).	18
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…	13
COLOR LBLG-198 The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.	12
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…	12
REGISTERED-341 The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that it appears the device is subject to listing under 510(j) and the initial distributor has not regis…	8

Import alerts listing Israel firms

Import alerts that list at least one firm in Israel: 21. Recently updated:

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

Recalls by Israel firms, last 5 years

90 (Class II: 76, Class I: 9, Class III: 5)

Recent recall reasons:

2026-09 Transfemoral catheter, positing arm may detached due to weld issue.
2026-09 Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalation, perforation of esophagus, obstruct…
2026-08 Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.

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.