Navigating FDA Compliance? Your Trusted US Agent is Your Gateway to the US Market.
U.S. Agent Services Medical Devices
Foreign medical device manufacturers must designate a U.S. Agent with the FDA as a condition of registration. We serve as your official U.S. representative managing FDA communications, coordinating inspections, and supporting your annual renewal requirements.
⏱ We respond to all inquiries within 24 business hours
Your U.S. Agent relationship can stay connected to establishment registration, device listing, FURLS support, UDI/GUDID submissions, label review, and annual renewal tracking through one accountable team.
U.S. Agent Services Medical Devices
Official Communication Hub
As your designated U.S. Agent, all official FDA CDRH correspondence, regulatory notices, and inquiries are directed to us nothing is missed.
- Primary FDA CDRH point of contact
- All official notices received & forwarded
- No missed communications due to time zones
- Regulatory inquiry handling
Inspection Coordination
We facilitate FDA Quality Management System Regulation (QMSR) inspections of your medical device facility coordinating logistics and ensuring you are fully prepared.
- FDA device inspection scheduling
- Pre-inspection readiness guidance
- QMSR documentation review support
- Post-inspection corrective action planning
Emergency Contact
For medical device recalls, MDR (Medical Device Reports), or safety alerts, the FDA contacts us immediately ensuring rapid response from your team.
- 24/7 emergency availability
- Device recall response coordination
- MDR reporting support
- Safety alert escalation
Registration & Annual Support
We assist with device establishment registration via FURLS, device listing, DUNS number maintenance, and annual renewal coordination.
- Device establishment registration (FURLS)
- Annual renewal coordination
- DUNS number maintenance
- Device listing support
Your Dedicated FDA Partner for Medical Devices
From Class I to Class III devices, our team understands the complexity of FDA device regulations. Choosing the right U.S. Agent means partnering with experts who provide the personal attention your compliance demands.
Getting FDA compliant has never been easier
Step 1: Register & Designate
Complete our short form and designate FDA Entry Point as your U.S. Agent.
Step 2: We Confirm
We confirm and submit your FDA registration update within 1 business day.
Step 3: Active Coverage
We receive all FDA communications on your behalf immediately.
Step 4: Ongoing Renewal
We track and file your registration renewal on schedule, so there’s never a lapse in coverage.
becoming
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Medical Device Services At a Glance
| Service | Who Needs It | Frequency | Timeframe | Pricing Starting at |
|---|---|---|---|---|
| U.S. Agent Services | Foreign facilities only | Annual | Before FDA registration; renew each year | $295/yr |
| Device Establishment Registration | Domestic & foreign | Annual | October-December each year | $349/yr |
| Medical Device Listing | All device companies | Annual | At registration; updated annually October-December | $50/device |
| Structured Product Labeling (SPL) | Device establishments | Per submission | At listing & with each labeling update | $249/submission |
| Device Label Review | All manufacturers | Per product/change | Before market entry or label revision | $449/product |
How to Change Your U.S. Agent
Already working with an agent? Here is how to switch to a new one without a gap in coverage.
Step 1: Select Your New U.S. Agent
Confirm the new agent agrees to the designation and provides a signed acceptance letter listing their U.S. address, phone number, and email address.
Step 2: Update Your Registration on FURLS
Log in to FURLS (the FDA Unified Registration and Listing System) and update the U.S. Agent fields on your facility registration with your new agent’s contact information.
Step 3: Submit the Update
The change takes effect immediately upon successful submission. The FDA does not charge a fee for this update.
Step 4: Confirm With Your New Agent
Verify that your new U.S. Agent has received the registration confirmation and is ready to act on your behalf.
Step 5: Notify Your Former Agent
Let your outgoing agent know the change is complete so there is no confusion if the FDA reaches out to them during the transition.
Important Timing Note
Federal regulations require you to update your U.S. Agent information within 60 days of any change. Do not leave a gap in U.S. Agent coverage: if the FDA attempts to contact your facility through an outdated or non-functional agent, it can trigger enforcement action, including import refusal and registration cancellation.
Medical Device U.S. Agent FAQs
Yes, if you manufacture medical devices outside the U.S. and want to register your facility with the FDA, you’re required to designate a U.S. Agent. This applies to Class I, II, and III devices alike.
We’re your official point of contact for FDA’s Center for Devices and Radiological Health (CDRH). That means we receive regulatory notices, coordinate inspection logistics, and escalate anything urgent, like a Medical Device Report (MDR) or recall notice, immediately.
Annually. FDA’s device establishment registration renewal window runs October 1 through December 31 each year. We track this and file on your behalf so there’s no lapse.
Establishment registration covers your facility. Device listing covers each specific product you market in the U.S. Both need to be kept current, and both renew on the same annual cycle.
Your registration can be considered invalid, which puts your ability to legally market devices in the U.S. at risk. This is exactly why ongoing U.S. Agent support matters beyond the initial registration.