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
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
your U.S.
Agent
Simple & Fast
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 |
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.