Holding Structure and the US Agent in the United States

1. Key takeaways

Under the United States system, the 510(k) holder is the manufacturer (or applicant) that submitted the premarket notification itself; the US Agent is not the license holder. According to the official FDA page, the US Agent does not bear the obligations of Medical Device Reporting (MDR) or 510(k) submission; its role is communication and passing information along. This differs structurally from markets where the certificates are handed to a local license holder. The consequence is that the ownership of the product’s regulatory position never leaves the manufacturer, and the choice of US Agent is a channeling decision rather than a custody decision. Understanding this early prevents contract structures built around assumptions imported from other markets, and it shapes how internal owners are assigned.

2. Legal basis

The structure described here rests on the following provisions and FDA pages, in force as of the verification date noted at the end of this page. Read together, they place the reporting and submission duties on the manufacturer and the importer, and leave the agent role outside those duties.

3. Expert insights

Insight one: the United States has no design of handing the certificate to a local license holder.

The United States structure is this: the manufacturer acts as the applicant holding the 510(k) or PMA, and the foreign manufacturer separately designates a US Agent as the information channel for FDA communications. On the concern common among Chinese companies that an agent may take away the certificate, the institutional basis in the United States differs from that in some Southeast Asian markets. The certificate-holding fear does not translate, because there is no local custody of the regulatory position to fear; the risk to manage instead is the quality of the communication channel, pending verification of the current arrangements at each appointment. When the channel fails, the practical consequence is not lost ownership but lost time: FDA correspondence that sits unanswered at the agent still belongs to the manufacturer to answer.

Insight two: the separation of responsibility from role is the core feature of the US Agent system.

According to the official FDA page, the US Agent does not bear MDR and 510(k) obligations. Product compliance responsibilities (registration, listing, MDR, corrections and removals, UDI, QMSR) all remain with the manufacturer, as do the corresponding records and evidence trails. This means that when selecting a US Agent, the focus is its communication capability and responsiveness, not any endorsement capability. A firm with no inspection experience and no submission record can still serve perfectly as a US Agent, and conversely a prestigious firm cannot transfer its reputation into the compliance performance of the product. Selection criteria should therefore test responsiveness in practice, with response-time expectations written into the agreement rather than assumed.

Insight three: the role of the initial importer must be recorded separately.

The initial importer (21 CFR 807.3(g)) bears its own four obligations, including MDR, corrections and removals, and tracking. It may commercially be the same partner, but its legal role differs from that of the US Agent, and the two must be recorded and contracted separately. The initial importer’s reporting duties under 21 CFR 803 and 806 attach to it personally, and they are not discharged by anything the manufacturer or the agent does.

The practical estimate is that every document touching the arrangement, from quality agreements to distribution contracts, should name the role explicitly, because a document that says only representative leaves the two roles ambiguous exactly where an inspector or auditor will look.

Insight four: when comparing across markets, state clearly that obligations cannot be shifted laterally.

The practice in markets such as Thailand and Indonesia of placing certificates in the hands of a license holder cannot be shifted laterally to the United States. Conversely, the United States structure of separating holding from agency cannot be applied directly to markets that require the license holder to hold the certificate. Multinational regulatory planning should therefore design each market structure from the local rules outward, resisting the temptation to reuse one regional template across all markets, pending verification of each market’s current requirements. The cost of designing per market is a planning overhead; the cost of reusing a wrong template is a compliance defect discovered at clearance or inspection.

4. Practical recommendations

• When designing the United States structure, determine the applicant or holder, the US Agent, and the initial importer as three separate positions and write them into documents.
• In the agreement with the US Agent, list its scope of duties item by item and explicitly exclude MDR and 510(k) obligations.
• Build the company’s own MDR and corrections-and-removals processes without relying on the agent.
• If one partner serves as both US Agent and initial importer, distinguish the obligations of the two roles in the documents.
• When running multiple markets in parallel, design the structure separately for each market without lateral shifting.

5. Verification checklist

• □ The 510(k) applicant or holder has been determined
• □ The US Agent role has been designated separately and its agreement confirmed
• □ The initial importer role has been determined (it may be the same entity as the US Agent, but must be recorded separately)
• □ The agreement states explicitly that the US Agent does not bear MDR and 510(k) obligations
• □ The company’s own MDR and corrections-and-removals processes have been established
• □ Structures for multiple markets have been designed separately, without lateral shifting

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, US Agent and local testing support for the United States market. Our team manages FDA establishment registration and listing, 510(k)/De Novo/PMA submissions, and supports post-market reporting obligations. Business enquiries: info@grzanglobal.com