mdi Consultants, Inc
For foreign medical device firms, FDA establishment registration and U.S. Agent designation are not optional—they are mandatory requirements for accessing the U.S. market. Errors in either process can lead to shipment delays, import holds, or FDA Import Alerts that disrupt business operations and market access.
Drawing on nearly 50 years of regulatory experience and supporting manufacturers worldwide, MDI Consultants regularly encounters five critical mistakes that can be easily avoided with proper planning and regulatory guidance.
FDA Establishment Registration: A Compliance Requirement That Can Make or Break U.S. Market Access
FDA establishment registration is not a one-time administrative task. It is an ongoing compliance obligation that requires annual renewal, a qualified U.S. Agent, and accurate device listings that must be updated as products and company information change.
Many foreign manufacturers treat registration as a formality and overlook these requirements. As a result, they may face FDA enforcement actions, including import alerts that can lead to shipment detentions, supply chain disruptions, and lost revenue.
After nearly 50 years of assisting medical device manufacturers worldwide, MDI Consultants continues to see the same registration mistakes repeated time and again. Fortunately, these issues are entirely preventable with proper oversight and compliance management.
Below are the five most common FDA establishment registration mistakes—and how to avoid them.
Mistake 1: Registering the Establishment but Failing to Maintain Accurate Device Listings
FDA establishment registration and device listing are two separate and distinct requirements. Registering your facility gives your establishment an FDA Registration Number. Listing your devices is a separate process that notifies the FDA of every device manufactured, repackaged, relabeled or contract manufactured at that facility — including the device name, FDA product code, device classification, and premarket submission number (510(k), PMA, or exempt status).
A common mistake among foreign manufacturers is assuming that establishment registration alone is sufficient. Many firms register their facility but fail to list all devices intended for U.S. distribution or neglect to update listings when products are added, modified, or discontinued.
The consequences can be significant. An unlisted device may be considered improperly marketed in the United States, even if the establishment itself is properly registered. During import reviews, FDA routinely verifies that devices entering the country are accurately listed. Any discrepancies can result in shipment delays, detention, or other enforcement actions.
What to do: To avoid these issues, firms should maintain a complete inventory of all devices marketed in the United States and ensure that each device is properly listed with the FDA. Device listings should be updated promptly whenever products are introduced, discontinued, or otherwise changed—rather than waiting for the annual registration renewal period.
Mistake 2: Failing to Designate a Qualified and Responsive U.S. Agent
The FDA requires all foreign medical device establishments to designate a US Agent under 21 CFR Part 807.40. This is a mandatory legal requirement that cannot be waived, regardless of company size or status. It is not satisfied by simply listing a U.S. distributor’s address without their formal designation and explicit agreement to act as the U.S. Agent.
A valid U.S. Agent must meet all FDA expectations for availability, reliability, and physical presence in the United States. Specifically, the U.S. Agent must:
- Maintain a physical place of business in the United States — a verifiable street address is required; a P.O. box is not acceptable
- Be available to the FDA during U.S. business hours, without significant delays caused by time zone differences
- Accept FDA communications on behalf of the foreign establishment, including inspection notices, correspondence, and import-related inquiries
- Coordinate and facilitate FDA inspections of the foreign establishment when required
MDI regularly encounters foreign firms who have listed a US firm as their US Agent without the firm’s knowledge or formal consent. If the FDA contacts that address and cannot reach the representative of the foreign establishment, the US Agent is not considered official and the firm is considered not in compliance with FDA requirements.
We also see firms who list their own US office as the US Agent — while this is permissible, it is only acceptable if the office is formally appointed, includes a clearly identified individual, is consistently available during FDA business hours, and fully understands the regulatory responsibilities associated with the role..
What to do: Designate a dedicated, qualified, properly authorized US Agent — either a specialized regulatory consulting firm like MDI Consultants Inc., or a named individual within your U.S. operations who has been formally trained and assigned this responsibility. The designation must be properly documented and maintained within your FDA FURLS account.
Mistake 3: Missing the Annual FDA Establishment Registration Renewal Window
FDA establishment registrations must be renewed annually between October 1 and December 31. This is a fixed window and does not vary based on the original registration date or duration of prior registration..
Missing the December 31 deadline results in immediate expiration of the registration, with no warning or grace period. Once expired, FDA systems may automatically flag and detain incoming shipments from the affected establishment. In many cases, manufacturers first learn of the lapse when a U.S. customs broker reports a shipment hold at the port.
To reinstate, the establishment must re-register, pay the annual FDA user fee again, and resolve any resulting import holds. Clearance typically takes two to four weeks or longer, depending on the circumstances.
What to do: Set reminders in September for the October 1 opening of the renewal window and complete renewal well before December 31—do not wait until the last week.
If using a consultant, ensure they are formally authorized to handle your annual renewal and that this responsibility is clearly included in the engagement scope.
Mistake 4: Confusing 510(k) Clearance with Establishment Registration
This is a common misunderstanding, especially among startup device companies going through FDA clearance for the first time.
FDA 510(k) clearance and FDA establishment registration are separate requirements with different purposes. A 510(k) allows a specific device to be marketed in the U.S., while establishment registration authorizes a facility to manufacture or distribute devices for the U.S. market.
Both are required. A cleared device cannot be legally distributed if it is manufactured at an unregistered establishment.
In practice, companies often either begin shipping before completing registration or allow registration to lapse during periods of inactivity, assuming clearance alone is sufficient.
What to do: Treat FDA establishment registration as an ongoing annual requirement, separate from product-specific approvals. Even if you are not actively shipping to the U.S., keeping your registration current preserves compliance and avoids delays, costs, and disruption from re-registration when you re-enter the market.
Mistake 5: Outdated Device Listings Create Compliance Risk
Device listings must be updated whenever there is a change to your product portfolio or regulatory status, including:
- Introduction of a new device for U.S. distribution
- Discontinuation of a listed device
- Changes to the device’s 510(k) or PMA status (including new submissions after significant modifications)
- Updates to FDA product code or classification
- Changes to the device’s trade name or intended use
Many foreign manufacturers only update device listings during the annual renewal period (October–December) and fail to maintain them throughout the year as changes occur.
FDA allows device listings to be updated at any time, and in some cases—such as introducing a new device—updates must be completed before U.S. distribution begins. Keeping listings current on a rolling basis is essential for compliance.
What to do: Build FDA device listing updates into your change control process. Any design change, new product launch, or discontinuation should trigger a listing review before the product is shipped to the U.S.
The FDA registration fee — FY2026
The FDA establishment registration user fee for fiscal year 2026 is $11,423, which is valid till September 30, 2026. There is no small business discount for establishment registration (unlike the 510(k) submission fee, which has a small business rate). The fee is due at the time of initial registration and at each annual renewal.
This fee covers registration only. It is separate from MDI’s fixed consulting fee for managing the registration process, and separate from any 510(k) or other premarket submission fees your device may require.
FDA Registration Done Right: Full-Service Management by MDI
MDI Consultants manages FDA establishment registration for foreign firms worldwide on a fixed-price basis. Our goal is to ensure full FDA compliance while minimizing administrative burden and regulatory risk.
Our registration service includes:
- FDA establishment registration and account setup through FDA FURLS
- Complete device listing for all products manufactured, relabeled, repackaged, or contract manufactured at the establishment
- S. Agent designation, with MDI serving as the official U.S. Agent (providing a U.S. physical address, FDA-hours availability, and full management of all FDA communications, including inspection notices and import-related correspondence)
- Annual renewal management, with proactive initiation with reminder emails starting from August and renewal process between October 1 and December 31 to ensure continuous compliance and prevent registration lapse
- Ongoing monitoring and updates to maintain accurate establishment and device listing records as products change
- Assistance with import alert resolution and reactivation of registrations in cases where prior compliance gaps have resulted in shipment delays or detention
For a no-obligation consultation and fixed-price quote, contact MDI at info@mdiconsultants.com or 516-482-9001.
Related resources:
- US Agent Services for FDA Compliance
- FDA Registrations
- Do foreign medical device manufacturers need a US Agent?
- FDA Regulatory Consulting — FAQ
