U.S. Agent Requirements, Consent Deadline, and Agent Changes

1. Key takeaways

Every foreign establishment must designate one U.S. Agent. According to FDA’s U.S. Agent page, the agent must respond within 10 business days of being designated to confirm consent to the appointment. When the agent is changed, the registration information must be updated within 30 days of the change, under 21 CFR 807.22(b)(2). Three rules therefore govern the agent relationship from beginning to end: the one-agent-per-establishment requirement, the 10-business-day consent confirmation, and the 30-day update on any change of agent.

• One U.S. Agent per foreign establishment, per FDA’s U.S. Agent page.
• Consent: the agent must reply within 10 business days of designation to confirm agreement.
• Qualification: the agent must reside or maintain a place of business in the United States, under 21 CFR 807.40.
• Change of agent: update the registration information within 30 days of the change, under 21 CFR 807.22(b)(2).
• Scope: FDA states that the U.S. Agent is not responsible for MDR reporting or 510(k) submissions.

2. Legal basis

The U.S. Agent framework combines a codified requirement in 21 CFR 807.40 with explanatory content on FDA’s U.S. Agent page, and links to the registration rules that determine how an agent change is processed.

3. Expert insights

Insight 1: One agent per establishment is a quantity rule, not a recommendation.

FDA’s U.S. Agent page makes clear that each foreign establishment must designate one U.S. Agent. For a corporate group that operates multiple foreign manufacturing establishments, the designation must be made establishment by establishment. A single agent appointment cannot be stretched to cover every site in the group by treating it as a blanket arrangement. This has direct structural consequences: the number of agent engagements, agreements, and consent confirmations scales with the number of registered foreign establishments, and a group-level framework should be designed so that each establishment’s agent designation is individually documented and individually maintainable. Because registration, listing, and agent data are reviewed together at clearance and during FDA communications, an incomplete or stale agent designation at any one establishment can create friction for the whole group’s shipments, which is why per-establishment discipline pays off.

Insight 2: The 10-business-day deadline is a consent confirmation clock, and it depends on the agent actively replying.

Under FDA’s page, the agent must respond within 10 business days of designation to confirm consent. The confirmation is not something the manufacturer can complete on the agent’s behalf; it requires the agent to act. Companies should therefore make the question of whether a candidate agent can complete the confirmation within 10 business days an explicit selection criterion at the procurement stage. If the confirmation stalls, the registration process stalls with it, because the designation is not effectively in place until consent has been confirmed.

Insight 3: Changing the agent is a change to registration information, and it follows the 30-day rule.

Agent information is a component of the registration information described in 21 CFR 807.25(b). Changing the agent therefore triggers the update obligation in 21 CFR 807.22(b)(2), and the update must be completed within 30 days of the change. It cannot be deferred to the annual update window. Companies that replace an agent should treat the switch as a registration event with its own deadline, and should retain evidence of the new agent’s consent alongside the update submission.

Insight 4: The U.S. Agent’s boundary of responsibility must be written into the agreement.

FDA’s page states explicitly that the U.S. Agent does not bear the obligations of MDR reporting and 510(k) submission. When GRZAN assists clients in signing agent agreements, it itemizes the liaison and forwarding functions the agent does undertake, and excludes, item by item, the matters that fall outside the agent’s obligations, so that responsibility disputes do not arise later. A written boundary protects both sides: the agent knows what it must answer for, and the manufacturer knows which regulatory duties remain its own, including adverse event reporting and premarket submissions.

4. Practical recommendations

The practices below keep the agent designation compliant from initial appointment through any subsequent change.

• Designate an agent establishment by establishment according to the number of foreign establishments, and do not attempt blanket coverage.
• When selecting an agent, confirm that it can complete the consent reply within 10 business days.
• When replacing an agent, update the registration information under the 30-day rule and retain evidence of the new agent’s consent.
• State the boundary of responsibility in the agreement: the agent handles liaison and forwarding; MDR and 510(k) obligations remain with the manufacturer.
• Verify that the agent has an actual residential address or place of business in the United States, not a post office box and not an answering service only.

5. Verification checklist

Confirm each item below for every foreign establishment before relying on the agent designation in a submission or an inspection.

• □ 1 U.S. Agent has been designated for every foreign establishment.
• □ The agent has an actual residential address or place of business in the United States.
• □ The agent’s written consent within 10 business days has been obtained and retained.
• □ A 30-day update process for agent changes has been established.
• □ The agreement assigns MDR and 510(k) obligations to the manufacturer.
• □ The agent is able to receive and to forward FDA communications.

Regulatory information verified as of October 28, 2026.

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