Avoid FDA Device Detention.
Secure Your U.S. Agent in 12 Minutes.
21 CFR 807.40 demands a physical U.S. presence for all foreign medical device manufacturers. We guarantee instant CDRH acceptance and full MDUFA liability protection for a flat $399/year.
Facility
CDRH Node
Import Alert DWPE is triggered instantly.
If your medical device establishment registration lapses, or if your U.S. Agent fails to respond to an FDA inquiry, your facility is automatically placed on FDA Import Alert. Every shipment you send to the U.S. will be halted at the port. Demurrage fees start immediately, ruining distribution contracts.
Entry Refused
HOLD: DWPE PROTOCOL
The "Hidden Fee" Trap.
Legacy regulatory firms lure you in with a high base fee, then charge you for every standard compliance task (like UDI syncs or 510(k) representation). We believe in one flat rate.
"Each foreign establishment required to register... must designate a United States agent... The U.S. agent must reside or maintain a place of business in the United States. A post office box is not permitted."
P.O. Box / Virtual
Assurentry HQ
The Physical Presence Mandate.
You cannot use a virtual office, a P.O. Box, or an answering machine. The law is absolute.
- Geographic Reality: Must reside in the US.
- 24/7 Availability: FDA emergency contact.
- Legal Proxy: Representations are legally binding.
Direct FURLS/DRLM Navigation.
Medical device establishments must pay a massive annual MDUFA user fee directly to the FDA (FY2026: $11,423). We ensure you pay the U.S. Treasury directly, without legacy firm markups.
The $12,523+
User Fee Reality.
Medical device establishments must pay a massive annual MDUFA user fee directly to the FDA (FY2026: $11,423 + processing). Legacy U.S. Agents often process this payment on your behalf, taking a hidden cut or delaying your registration.
Direct FURLS Routing
We don't touch your FDA user fee. You pay the FDA directly via the FURLS DRLM portal. We just execute the legal handshake.
Translating CDRH Legalese.
When the FDA sends a Form 483 or Warning Letter regarding QSR/ISO 13485 violations, misinterpreting it can lead to facility suspension. We translate the risk into an actionable CAPA plan.
During an inspection of your firm located at the above address on [DATE], an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures medical devices.
We found significant violations of the Quality System regulation, Title 21, Code of Federal Regulations, Part 820 (21 CFR part 820).
Failure to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).
Specifically, your firm failed to analyze processes, work operations, concessions, quality audit reports, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems.
The FDA Re-inspection Liability Trap.
Under MDUFA, the U.S. Agent is financially liable for FDA re-inspection costs (often exceeding $15,000). Competitors refuse to act as agents or charge massive retainers. Assurentry absorbs this risk.
FDA Re-inspection Bill
Under MDUFA, the FDA bills the U.S. Agent directly for medical device facility re-inspection costs. If the agent defaults, your device registration is suspended.
Assurentry Shield
Because of this massive financial liability, legacy competitors force foreign device manufacturers to deposit $15,000+ into an escrow account just to act as your agent.
Our corporate liability insurance completely absorbs the MDUFA risk, meaning you keep your capital while maintaining perfect FDA compliance.
Your Hub for 510(k), PMA & UDI.
Your U.S. Agent acts as the central regulatory proxy, fielding inquiries from the FDA regarding your premarket clearance submissions and GUDID entries.
510(k) & PMA
Market ClearanceUDI / GUDID
Database Sync"Your U.S. Agent acts as the central regulatory hub, fielding inquiries from the FDA regarding your 510(k) clearance letters, PMA submissions, and Global Unique Device Identification Database (GUDID) entries."
The Notice of Inspection (NOI) Interceptor.
When the FDA decides to inspect your foreign device facility, they call your U.S. Agent first to schedule it. A missed call flags you as non-cooperative. We intercept, negotiate dates, and prep your ISO 13485 team.
U.S. Agent
FDA"We are scheduling a Level 2 Medical Device inspection of your client's facility. Confirm receipt."
Without an agent answering, the FDA flags the facility for non-cooperation immediately, putting all 510(k) and PMA market access at risk.
Triage
The Annual Renewal Trap.
Unlike food facilities (biennial), medical device establishment registrations must be affirmatively renewed every single year between October 1 and December 31. Assurentry guides you through the process via DRLM for free. You will never wake up on January 1st to a cancelled registration.
Annual Registration Renewal
Unlike food facilities, medical device registrations expire every single year.
Auto-Renewal
Our system automatically initiates the annual renewal via the FDA FURLS portal, guiding you through MDUFA fee payment and U.S. Agent verification.
FDA Emergencies Wait For No One.
The FDA operates on EST. If an MDR or Class I Recall notice is sent at 4:00 PM EST, it might be 4:00 AM in your country. We provide 24/7/365 coverage for over 160+ countries.
CDRH emergencies wait for no one.
The FDA operates on U.S. Eastern Standard Time (EST). If an emergency communication regarding an MDR (Medical Device Report) or Class I Recall is sent at 4:00 PM EST, it might be 4:00 AM in your country. The FDA expects the U.S. Agent to answer immediately.
24/7/365 Coverage
We support over 160+ countries. When the FDA calls, we answer on the first ring.
The Secure Audit Vault.
Every CDRH interaction, establishment registration, and 510(k) clearance letter is cryptographically stored and instantly accessible for your buyers or inspectors.
Regulatory Document Vault
Every CDRH interaction, Establishment Registration, 510(k) clearance letter, and Establishment Inspection Report (EIR) is cryptographically stored.
U.S. Agent Designation Cert
Establishment Registration
510(k) Clearance Letter
Radical Transparency.
We answer the hard questions our competitors won't.
One flat fee. Complete peace of mind.
Stop paying hourly retainers for mandatory compliance.
U.S. Agent Designation
The complete compliance representation package for medical devices.
Secure SSL Checkout. No setup fees. Cancel anytime.
What's Included:
- Official 21 CFR 807.40 Designation
- Liability Shield (Re-inspection fees)
- Free Annual Renewal Guidance
- 510(k) / PMA Agent Proxy
- UDI / GUDID Support
- Unlimited FDA Comm Handling
- Digital Compliance Certificate
Certificate of Designation
U.S. AGENT FOR MEDICAL DEVICES
Secure Your Supply Chain.
Don't let a clerical error stop your shipment at the border. Join 2,800+ food companies who trust Assurentry for automated compliance.