US Agent for Foreign Medical Device Establishments (12 Months)
Phoenix Safety Consultants LLC acts as the FDA US agent for your foreign device establishment for 12 months.
- Signed by a qualified safety assessor
- Regulator-ready, or we revise it free
- Delivered in 24, 48 or 72 hours
Trusted by brands including
Service details
Everything included, explained
Quick answer
Foreign medical device establishments must name a US agent who lives or has a place of business in the US, under 21 CFR 807.40. Phoenix Safety Consultants LLC acts as your US agent for 12 months, receives FDA communications and helps FDA arrange inspections. FDA fees, testing and labs are excluded. £565 per year.
What's included in your US agent service
| Document | What it is |
|---|---|
| US agent designation | Phoenix Safety Consultants LLC named in your registration |
| FDA communications | Received and forwarded promptly |
| Inspection scheduling | Assist FDA in arranging inspections |
| Agreement | Written duties and term |
Who this service is for
- UK, EU and other non-US device manufacturers
- Makers of menstrual and beauty devices exporting to the US
- Establishments whose US agent is changing
What this service does not include
- FDA fees. FDA's annual device establishment registration fee ($13,785 for FY2027, 1 Oct 2026 to 30 Sep 2027) is extra and paid by you.
- Testing. Laboratory testing, lab fees and test reports are not included.
- Registration and listing. Available separately.
- Importer or distributor duties.
How it works
- Agreement You sign the US agent agreement.
- Designate You or we name Phoenix Safety Consultants LLC in FURLS.
- Confirm FDA contacts the US agent to confirm.
- Cover 12 months of US agent service.
What is a US agent for medical devices?
21 CFR 807.40 requires every foreign establishment that registers with FDA to name a US agent who resides or keeps a place of business in the US. FDA contacts the US agent to confirm the designation, sends communications through them, and may ask them to help arrange inspections. Phoenix Safety Consultants LLC acts as your US agent.
US agent duties
Under 21 CFR 807.40(b):
- Assist FDA with communications about the establishment.
- Respond to questions about devices imported or offered for import.
- Help schedule inspections.
- Receive FDA information on behalf of the establishment.
What you receive
- Signed US agent agreement
- US agent details for FURLS
- 12 months of cover and a renewal date
Legal framework
- 21 CFR 807.40 — foreign establishments and US agent
- FD&C Act section 510(i) — foreign establishment registration
Official sources:
Why brands choose Phoenix
- Phoenix Safety Consultants LLC (USA), our sister company.
- Fast forwarding of FDA messages.
- Reviewed by Syed Muhammad Shamuel Shees, US Regulatory Lead.
Name a US agent you can reach. Order above, or message us on WhatsApp on +44 7346 009332.
Frequently asked questions
Do foreign device manufacturers need a US agent?
Yes. 21 CFR 807.40 requires every foreign establishment registering with FDA to name a US agent.
What does a US agent do?
Receives FDA communications, answers FDA questions about imported devices and helps FDA schedule inspections.
Is the US agent the importer?
No. Importer and distributor duties are separate.
Are FDA fees included?
No. FDA's annual device establishment registration fee ($13,785 for FY2027, 1 Oct 2026 to 30 Sep 2027) is extra and paid by you.
Is testing included?
No. Laboratory testing, lab fees and test reports are not included.
How much does the service cost?
£565 for 12 months.