FDA · U.S. Agent · Device Registration & Listing
U.S. Agent Service for Foreign Medical Device Manufacturers
For foreign device manufacturers, a U.S. Agent is a regulatory requirement—not a formality. Sobel acts as your U.S.-based point of contact so FDA has a reliable channel to reach you, ask questions about devices offered for import, and coordinate inspections. We structure the association in FDA’s Device Registration and Listing Module (DRLM), track communications, and keep contact details updated within required timelines.
U.S.-based point of contact
FDA communications routed and tracked
Inspection scheduling support
What This Service Is — and Is Not
We keep the U.S. Agent role precise, aligned with FDA expectations, and clearly separated from importer or legal services.
What It Is
- U.S.-based point-of-contact service for your foreign establishment.
- Facilitation of FDA communications related to your devices imported or offered for import into the U.S.
- Responding to FDA questions about your products and serving as the first contact to route issues internally.
- Assistance with scheduling FDA inspections of your foreign establishment.
- Optional: acting as Official Correspondent for registration and listing communications, if you choose to designate us.
What It Is Not
- Not a legal representative or provider of legal advice.
- Not your initial importer or commercial distributor in the U.S.
- Not a customs broker or logistics provider.
- Not a substitute for internal regulatory responsibility—your establishment remains responsible for compliance.
Why a Compliant U.S. Agent Matters
U.S. regulations require that foreign establishments identify a single U.S. Agent, with clear duties in communications and inspection coordination.
- Foreign device establishments that import or offer devices for import into the U.S. must designate one U.S. Agent and may also designate that agent as Official Correspondent.
- The U.S. Agent must reside in the U.S. or maintain a place of business in the U.S. and assist FDA by facilitating communications, answering questions about devices, and helping with inspection scheduling.
- Changes to U.S. Agent contact details (name, address, phone) must be reported to FDA within 10 business days.
- The association between your establishment and the U.S. Agent is maintained in FDA’s Device Registration and Listing Module (DRLM) and must be kept accurate.
What You Will Receive
The service is built around four concrete outputs that make the U.S. Agent role visible, traceable, and easy to audit.
Agent Appointment Package
- Draft appointment letter confirming Sobel as your U.S. Agent for FDA device purposes.
- Step-by-step guidance for associating Sobel as U.S. Agent in FDA’s DRLM (within FURLS).
- Optional language to designate Sobel as Official Correspondent for registration and listing, if you choose that add-on.
FDA Communications Handling
- Central email and process for receiving FDA notices and information requests.
- Tracked routing of questions to your internal contacts with agreed response windows.
- Status log summarizing each FDA interaction and how it was closed.
Inspection Coordination Support
- Assistance in responding to FDA inspection scheduling notices for your foreign establishment.
- Basic preparation checklist aligned to the notice type (e.g., on-site inspection vs. records requests).
- Coordination of timing and contacts so both FDA and your local team know who will handle what.
Annual Verification & Contact Updates
- Annual check-in to verify that establishment and agent contact details in DRLM remain correct.
- Prompts and guidance to update FDA within 10 business days of any change to U.S. Agent contact details.
- Documentation of updates for internal audit and inspection readiness.
How Our U.S. Agent Service Works (4 Steps)
A simple structure so you know exactly how the U.S. Agent role will be set up and operated.
Appoint & link
Set up communications
Operate the U.S. Agent role
Maintain & update
What We Need From You
- Foreign establishment details, including legal name, address, and registration/listing identifiers.
- Access to your FDA DRLM account (or a clear internal process) so Sobel can be associated as U.S. Agent.
- Escalation contacts and expected response windows for different notice types (information requests, inspection scheduling, urgent safety issues).
- Current registration and listing status, plus any known upcoming FDA milestones (renewals, new listings, corrections).
Why Foreign Manufacturers Work With Sobel as U.S. Agent
We focus on being a precise, responsive regulatory contact—not an importer or legal surrogate—so your interactions with FDA are organized and defensible.
- U.S.-based presence dedicated to facilitating FDA communications for foreign device establishments.
- Clear separation between U.S. Agent duties, Official Correspondent tasks, and importer or customs responsibilities.
- Structured tracking of communications and inspection scheduling activity, so nothing depends on a single inbox or individual.
- Practical documentation (letters, logs, checklists) you can present in inspections or internal audits.
- A critical, pragmatic approach: we route questions efficiently while keeping responsibility where it belongs—within your establishment.
FREQUENTLY ASKED QUESTIONS
If you are a foreign establishment that imports or offers devices for import into the United States, you must designate one U.S. Agent so FDA has a reliable point of contact.
Yes. You may designate your U.S. Agent to act as Official Correspondent for registration and listing communications. This is optional and can be added to the service.
The association is managed in FDA’s Device Registration and Listing Module (DRLM), accessed through the FURLS system.
Changes to the agent’s name, address, or phone number must be reported to FDA within 10 business days
No. We act as your U.S. Agent for FDA communications. We do not act as importer of record, customs broker, or legal representative.
No. The foreign establishment remains responsible for device safety, effectiveness, and regulatory compliance. The U.S. Agent provides a structured communication channel and support for FDA interactions.
Appoint a U.S. Agent That Keeps FDA Communications Under Control
If you are a foreign manufacturer offering devices for import into the U.S., you must have a U.S. Agent. Sobel provides a precise, well-documented U.S. Agent service—covering communications, questions about your imported devices, inspection scheduling support, and annual verification—without blurring the lines with importer or legal roles.
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