Do You Need a US Company, and How Far Apart Are 510(k) and PMA?
A single-country US medical-device entry plan: classify first, split into 510(k), De Novo, or PMA, keep the clearance or approval with the manufacturer through a Mode A US Agent structure, then use FDA as a high-leverage reference approval in selected downstream markets.
Regional verdict
The United States is the world's largest medical-device market and one of the most foreign-manufacturer-friendly holder structures in this library: a foreign manufacturer can retain its own clearance or approval and appoint a US Agent as the required communication interface, without establishing a US company merely to hold the authorization. The difficulty is technical, not corporate. A 510(k) is built around substantial equivalence to a legally marketed predicate; De Novo creates a new low-to-moderate-risk device type where no suitable predicate exists; PMA is the most stringent route and requires valid scientific evidence of safety and effectiveness. The source page gives a 90-day FDA target and a common 4–9 month review range for 510(k), versus a 180-day target and a practical 3–7 year range for PMA including clinical work and information rounds.
Standard pathway flow
Treat classification and predicate strategy as the first gate. Establishment registration, listing, and launch come after the correct premarket route is fixed.
1. Confirm product code and classification
Product Code plus Intended Use determines the class and pathway. Use FDA's classification database; where classification remains uncertain, the country page identifies a 513(g) request as the formal classification-request option.
2. Split into 510(k), De Novo, or PMA
Use 510(k) mainly for Class II devices that can demonstrate substantial equivalence to a legally marketed predicate. Use De Novo for a novel Class I or II device without an appropriate predicate. Use PMA for Class III devices requiring valid scientific evidence of safety and effectiveness; US clinical studies require the applicable IDE step.
3. Designate the US Agent and register the establishment
A foreign establishment must designate a US-based Agent before FDA establishment registration. Register the foreign manufacturing facility in FURLS, define its manufacturing activities, and maintain the annual registration cycle.
4. Submit, answer review questions, and obtain the decision
Submit the applicable package electronically, pass acceptability review, and answer Additional Information requests. A 510(k) ends in an SE or NSE decision; De Novo establishes a new device type; PMA approval carries annual-report and supplement duties for significant changes.
5. Complete device listing and launch controls
After clearance or approval, list the device in FURLS before marketing and maintain QMSR, English labelling, UDI/GUDID, import, complaint, adverse-event, correction, and recall obligations.
License-holder arrangements
The US uses Mode A: the foreign manufacturer keeps the clearance or approval, while a US Agent supplies the mandatory local communication presence. This is structurally different from the distributor- or Sponsor-held Mode B model used across much of Asia, including Australia.
Manufacturer: authorization control
The manufacturer remains the applicant and authorization owner. A US company is not required solely to hold the FDA clearance or approval.
US Agent: communication role
The US Agent receives and relays FDA communications and inspection notices, must be reachable within 24 hours, and is neither the licence holder nor necessarily the distributor.
Importer: a separable execution role
The Importer of Record handles customs entry and compliance checks. The country page expressly separates this role from the US Agent.
A mandatory US Agent does not create local certificate ownership. Keep the regulatory communication, import, and commercial-distribution roles contractually distinct.
Reference-certificate leverage
- Inbound: FDA recognizes no foreign reference approval. CE can contribute reusable test, risk, and clinical documentation, but cannot replace or shorten the independent 510(k), De Novo, or PMA review; NMPA status carries no positive or negative weight.
- Outbound — the Americas and Gulf: FDA is one of Brazil's four named AREEs, one of the three authorities in Mexico's original Acuerdo de Equivalencia, and one of five formally equal reference agencies for Saudi Arabia's Abridged Review.
- Outbound — Asia: FDA alone can qualify defined South Korean categories for the FDA-specific Abbreviated Review; an FDA approval held for at least one year is among Thailand's Expedited Review references; and FDA 510(k), De Novo, or PMA is one of Singapore HSA's five named agencies for its Abridged/Immediate/Expedited system.
- Outbound — Australia: FDA 510(k), De Novo, or PMA sits at the same highest OCA tier as qualifying Notified-Body CE. The dated 41HD route is not an FDA benefit: the allowed sources identify it as a separate May 1, 2026 NMPA exception within an eight-reference-regulator mechanism.
Suggested entry sequence
Start with classification and a Pre-Sub where the source page recommends it, then build the predicate, testing, clinical, QMS, and software evidence around the selected 510(k), De Novo, or PMA route. Do not treat CE or NMPA status as an FDA shortcut.
Once FDA clearance or approval is secured, screen Brazil, Mexico, Saudi Arabia, South Korea, Thailand, Singapore, and Australia against each market's own named route, scope, classification, holder, labelling, and post-market rules.
Country-by-country delta table
| Country | Regulator | Registration form | Licence holder mode | Validity | Key special requirement |
|---|---|---|---|---|---|
| United States | FDA / CDRH | 510(k) clearance, De Novo classification, or PMA approval according to product code, intended use, class, and predicate availability; followed by establishment registration and device listing | Mode A — manufacturer retains the clearance or approval; foreign establishments appoint a mandatory US Agent | 510(k) clearance has no expiry; establishment registration and device listing are maintained annually; PMA products require annual reports | QMSR, English labelling, UDI/GUDID, foreign-facility inspection readiness, and route-specific predicate or clinical evidence |
Common pitfalls
- Choosing the wrong 510(k) predicate: the country page calls unsuitable predicate selection the leading cause of RTA and NSE outcomes. Confirm legal marketing status, intended use, technological characteristics, and that the predicate has not been rescinded.
- Treating establishment registration as a one-time formality: foreign facilities must renew annually between October 1 and December 31. The source page records the FY2026 establishment-registration fee as USD 11,423 per year and warns that lapse can stop lawful importation.
- Mis-scoping the US Agent: the Agent must be designated before establishment registration, relay FDA inspection notices, and remain reachable within 24 hours, but is not the licence holder, distributor, or bearer of product-compliance liability.
Explore the country pages
Each row links to the full country regulatory report for registration pathway, timeline, cost, and post-market obligations.