Why Your FDA US Agent Matters More in 2025: What Foreign Manufacturers Are Learning the Hard Way
Disclaimer. This article differentiates regulatory law from observed practice. The legal requirements for foreign manufacturers to designate a US agent are set in 21 CFR 807.40. EU Authorized Representative obligations (including availability) are in MDR Article 11. Insights below include practitioner observations from 2023–2025 and are not legal advice.
You’ve performed well in your home market—MDR certificate in the EU, NMPA authorization in China, PMDA pathways in Japan, MFDS in Korea. Documentation is solid. Then the first US shipment reaches customs and the focus shifts to operations: who is your FDA US agent, are they available now, and can they coordinate quickly?
Law vs. practice. The regulations didn’t change in 2025. What many teams report is steadier follow-through on existing requirements. When the agent channel is slow or unclear, import queries linger—regardless of your CE mark.
What Actually Changed: Enforcement Energy, Not New Rules
To avoid ambiguity: the points below reflect industry experience (brokers, consultants, client cases). They are not FDA-published statistics.
- Import screening feels stricter. Agent detail mismatches (contact names, phone/email, establishment linkage) appear to trigger holds more readily than several years ago.
- Inspections resumed at pace. Post-COVID resumption means investigators often initiate contact via the listed US agent; same-day routing minimizes friction.
- Cross-checks on basics. Who represents you, whether they respond, and whether they understand your devices. Thin agent setups invite deeper questions.
Observation notice. These are practitioner observations and broker feedback (2023–2025). If you require verified data, review FDA’s public records (import refusals, warning letters, inspection classification reports). Where official statistics are unavailable, treat this as industry experience, not agency position.
MDSAP: Helpful Coordination, Separate from the US Agent Channel
MDSAP drives cross-jurisdictional QMS oversight. Useful. But the US agent’s core function—being reachable by FDA and routing communications—sits outside the MDSAP audit cycle. A clean MDSAP history won’t resolve an import query if the agent doesn’t respond promptly. Treat the agent process as a distinct operational control.
US Agent ≠ EU AR (and differs from Asia models)
| Dimension | EU Authorized Representative (MDR) | FDA US Agent | China (NMPA) Local Agent | Japan (PMDA) MAH | Korea Importer of Record |
|---|---|---|---|---|---|
| Core purpose | Official EU contact; vigilance interface; access to technical documentation. | Domestic point of contact so FDA can reach the foreign establishment; facilitates communications and inspection scheduling (21 CFR 807.40). | Domestic liaison for submissions and post-market activities per Chinese regulations (NMPA agents). | Authorization holder responsible for market compliance in Japan (MAH construct under PMD Act). | Commercial entity responsible for importing goods into Korea; customs and taxation focus, not regulatory liaison. |
| Holds your tech file? | Often yes (or guaranteed access). | No by default; emphasis on availability and accurate routing. | Typically maintains filing set per local requirements. | Holds/controls authorization dossiers. | No; customs documentation, not technical files. |
| Availability expectation | “Permanently and continuously” at disposal in the EU context (MDR Art.11). | Reachable during US business hours; rapid escalation. Industry practice targets 24–72 hours; this is not an FDA-published SLA. | Domestic accessibility to authority (per NMPA practice). | Continuous oversight aligned to authorization duties. | Availability driven by customs and logistics schedules. |
| Common failure mode | Named but weakly integrated with PMS/PRRC workflow. | Registered but non-responsive; unfamiliar with product scope and contacts. | Lag between factory and local agent responses. | Role fragmentation across MAH and manufacturer. | Assuming IoR equals a regulatory agent (it doesn’t). |
Citations. EU: MDR Article 11 (Authorized Representative obligations). US: 21 CFR 807.40 (US agent designation by foreign establishments). Response-time expectations are industry practice, not a regulatory requirement.
Should Your Distributor Be Your US Agent?
Common, but high-risk due to conflicting incentives and control over communications. Keep sales and regulatory routing separate. Independence improves clarity and response quality during FDA interactions.
Import Detention When the Agent Fumbles (Hypothetical Scenario)
A European Class IIa manufacturer appoints a “mailbox” agent. First US shipment: a basic verification request goes to the agent. Two days pass (holiday overlap). The agent forwards the email without escalation. The entry stalls; costs escalate; subsequent questions multiply. The pattern is avoidable with tested escalation and live coverage.
Evidence transparency. The scenario above is illustrative—based on common patterns found in public correspondence and practitioner experience. Where you need formal evidence, consult FDA’s public warning letters and import data. If no data address your specific concern, treat this as professional judgement rather than agency position.
Why Home-Market Success Doesn’t Protect You in the US
Strong MDR/NMPA/PMDA histories are valuable. The US also measures operational reachability through the US agent channel. PRRC responsibilities, MAH structures, or an importer of record cannot substitute for a responsive US agent aligned to your team and broker.
Beyond Europe: Notes for Asian Manufacturers
Time zones. A 2 p.m. ET email is 3 a.m. in Beijing and 4 a.m. in Tokyo. Establish a “US agent watch” rotation during shipments and inspection windows to avoid day-long delays.
Language and tone. FDA uses direct, plain English. Your agent should clarify intent and timelines in every thread (e.g., “acknowledged—response by EOD ET”).
China (NMPA). The NMPA agent model does not map to FDA; treat the US agent role as distinct with responsiveness expectations.
Japan (PMDA/MAH). Expect less formality; concise answers and named escalation owners work well.
Korea/Taiwan. Distributor-as-agent is common and often problematic. Separate roles to avoid conflicts and delays.
India. With historically frequent FDA inspections, assign who confirms inspection dates within hours, not days. “Lowest-cost agent” arrangements often cost more when shipments stall.
US Agent Due Diligence Checklist
- Responsiveness drill. Live-call during US hours. Confirm pickup time, backup coverage, and escalation path.
- Device literacy. Can the agent state intended use and risk class for each family?
- Escalation map. Named primary + backup with direct lines; coverage for US and your local holidays.
- Broker alignment. Customs broker maintains a verified, tested agent contact.
- Metrics & cost. Track response time, count of agent-mediated holds, time-to-release. Budget for capability—not just an address.
Operational and Financial Impact
Delays accrue demurrage, rescheduling fees, and reputational cost with customers. A capable agent reduces variance in release times and preserves margin. Model the total cost of delay against agent service levels to justify investment.
What to Do Next
- Quick audit + live test. Verify phones, backups, and escalation within your internal 24–72 hour target (industry practice).
- Data hygiene. Align agent details across FDA registration/listings, broker files, and SOPs.
- Micro-SOP. “FDA email → agent alerts named people → receipt confirmed same business day.”
- Holiday map. Overlay US and local holidays; assign coverage.
- Adjust fast. If metrics slip, change the setup—don’t wait for quarter-end.
Timeline Expectations
Fix the basics this week—contact hygiene, escalation paths, broker alignment—and you’ll feel it on the next shipment. Two to four weeks typically hardens the agent relationship and rehearsal for an inspection invite. A quarter is enough to stabilize metrics. Treat the US agent as part of your first line of compliance.
Reminder on evidence. Where statistics aren’t cited, treat statements as professional observations. For company-specific decisions, consult qualified US regulatory counsel.
Methodology & Legal References
Methodology. Synthesis of consultant engagements, customs-broker feedback, and manufacturer experiences (2023–2025). Observational content is labeled as such where data are unavailable.
US Agent Law. Foreign device establishments designate a US agent; see 21 CFR 807.40 (official eCFR).
EU AR Context. Authorized Representative obligations—including being “permanently and continuously” at the manufacturer’s disposal—see Regulation (EU) 2017/745, Article 11 (EUR-Lex).