Who is required to have an FDA U.S. Agent?

Any foreign establishment that manufactures, repacks, relabels, or is otherwise responsible for a drug, biologic, or medical device distributed in the United States must designate a U.S. Agent.

What does an FDA U.S. Agent actually do?

The U.S. Agent receives and forwards official FDA correspondence and requests, assists with scheduling FDA inspections, and is the FDA's primary point of contact for your establishment.

What happens if FDA needs to contact my establishment?

FDA contacts your U.S. Agent directly. The agent is required to forward all communications to you promptly. SLA and interaction terms vary by provider — check each agent's response policy.

Can I change my FDA U.S. Agent?

Yes. You can update your U.S. Agent by submitting a new FDA establishment registration (Form FDA 3537/FDA FURLS). Most agents will help you with the transition.

Is the FDA U.S. Agent the same as the FDA Authorized Agent?

For medical devices, yes — the terms are used interchangeably. For drugs/biologics, the U.S. Agent is a separate requirement from a DMF/NDA authorized agent.

Appoint a Vetted FDA U.S. Agent in 2 Minutes

Appoint an FDA U.S. Agent online in minutes. Compare vetted agents with instant annual pricing — required for all foreign device and drug manufacturers registering with FDA.

✓ 9 active providers available right now · USD 250 – 1,050

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Market

United States

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Regulation

FD&C Act §510(f)

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Onboarding

1–3 business days

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Pricing

Annual fee

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How it works

1

Tell us about your establishment

Select your billing period and how many FDA interactions you need included in your bundle.
2

Compare agents with instant pricing

View annual fees, response SLAs, and interaction bundles from vetted U.S. Agents who handle FDA communications.
3

Appoint your agent and update FDA records

Confirm your choice and your new U.S. Agent will provide the information you need to update your FDA establishment registration.

Who needs an FDA U.S. Agent?

Section 510(f) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Safety and Innovation Act (FDASIA), requires every foreign establishment that manufactures, prepares, propagates, compounds, or processes a drug or device for distribution in the United States to designate a single U.S. Agent. This includes contract manufacturers, specification developers, repackers, and re-labelers. Foreign establishments registered with FDA for device manufacturing must have a U.S. Agent listed at all times — failure to maintain one can result in your registration being placed on hold or your products being refused entry at the border.

What does an FDA U.S. Agent do?

The U.S. Agent serves as the official liaison between FDA and your foreign establishment. Their responsibilities include: receiving and forwarding all FDA communications (including inspection notices, 483 observations, and warning letters) to your establishment promptly; assisting FDA in scheduling and facilitating inspections at your site; translating regulatory communications where needed; and maintaining awareness of your registration status in FDA FURLS (FDA Unified Registration and Listing System). Critically, the U.S. Agent is required to be available 24/7 during FDA working hours — not just during your local business hours.

How much does an FDA U.S. Agent cost?

Annual FDA U.S. Agent fees typically start at USD 129–250 for a basic annual appointment covering standard communications forwarding. Bundles that include inspection facilitation support, 24/7 availability, extra interaction packs, and dedicated account management range from USD 500 to USD 890 per year. The price varies significantly based on response SLA, number of included interactions, and whether you need support during an active FDA inspection or enforcement action. On Cruxi Bridge, you see itemized annual pricing instantly — including optional add-on bundles — before you commit.

How to choose an FDA U.S. Agent

The most important criteria are: (1) Physical U.S. presence — confirm your agent has a genuine U.S. office with staff available during FDA working hours (not just a mail forwarding service); (2) FDA inspection experience — if your establishment has a history of FDA observations or inspections, choose an agent with hands-on inspection facilitation experience; (3) Response SLA — how quickly will they forward FDA communications to you? Sub-24-hour forwarding is standard; (4) Communication log/ticketing system — the best agents provide a documented log of all FDA interactions for your quality records; and (5) Experience with your product category (devices vs. drugs vs. OTC cosmetics).

Updating your FDA U.S. Agent

To change your U.S. Agent, you log into FDA FURLS and update your establishment registration with the new agent's information. Your outgoing agent's appointment terminates on the date of the change. There is no grace period — FDA must always have a current, reachable U.S. Agent on file for your establishment. Your incoming U.S. Agent will typically provide the exact information you need to enter into FURLS. The entire update process usually takes 15–30 minutes in the FDA portal once you have the new agent's details.

Frequently asked questions

Who is required to have an FDA U.S. Agent?: Any foreign establishment that manufactures, repacks, relabels, or is otherwise responsible for a drug, biologic, or medical device distributed in the United States must designate a U.S. Agent.
What does an FDA U.S. Agent actually do?: The U.S. Agent receives and forwards official FDA correspondence and requests, assists with scheduling FDA inspections, and is the FDA's primary point of contact for your establishment.
What happens if FDA needs to contact my establishment?: FDA contacts your U.S. Agent directly. The agent is required to forward all communications to you promptly. SLA and interaction terms vary by provider — check each agent's response policy.
Can I change my FDA U.S. Agent?: Yes. You can update your U.S. Agent by submitting a new FDA establishment registration (Form FDA 3537/FDA FURLS). Most agents will help you with the transition.
Is the FDA U.S. Agent the same as the FDA Authorized Agent?: For medical devices, yes — the terms are used interchangeably. For drugs/biologics, the U.S. Agent is a separate requirement from a DMF/NDA authorized agent.

How Cruxi Bridge vets providers

✓ Every provider submits regulatory expertise evidence and jurisdictional coverage claims
✓ Providers that go live agree to the Cruxi Bridge Provider Terms including service delivery and accuracy obligations
✓ Payment is held by Cruxi and only released to the provider after service delivery milestones
✓ Buyers can raise a dispute within 30 days — Cruxi reviews and mediates per the platform terms

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