How to Change Your FDA U.S. Agent: Step-by-Step Process

When Should You Change Your U.S. Agent?

Foreign facilities change their FDA U.S. Agent for a variety of reasons: poor communication, high fees, slow response times, or because their current agent is going out of business. Whatever the reason, the FD&C Act requires that your U.S. Agent information remain current at all times. Under 21 CFR §1.234 (food) and similar provisions for drugs and devices, you must update your registration within 60 days of any change to your U.S. Agent.

Common triggers for changing agents include:

• Your current agent is unresponsive or difficult to reach
• You are paying significantly more than market rates
• Your agent failed to forward critical FDA communications
• You need an agent that covers multiple product categories
• Your current agent is discontinuing their services

Step-by-Step: Changing Your U.S. Agent

The exact process depends on your product category, but the general steps are consistent:

1. Select your new U.S. Agent: Confirm that your new agent is located in the United States and has agreed to serve as your U.S. Agent. Obtain their name, address, phone number, and email.
2. Log in to the FDA registration portal: Access the appropriate system — FFRM for food, DRLS for drugs, FURLS for devices, or Cosmetics Direct for cosmetics.
3. Navigate to your registration record: Locate your active facility registration and select the option to update or amend.
4. Replace the U.S. Agent information: Remove the current agent's details and enter the new agent's information.
5. Submit the update: Confirm and submit. FDA typically processes the change within 1–3 business days.
6. Verify the update: Check that your registration reflects the new U.S. Agent. Request a confirmation letter from your new agent.

Process Differences by Product Type

Food Facilities (FFRM)

Food facility registrations are managed through the Food Facility Registration Module (FFRM) at access.fda.gov. You can update your U.S. Agent at any time, but the change must also be confirmed during the biennial renewal window (Oct 1–Dec 31 of even-numbered years). Under 21 CFR §1.234, changes must be submitted within 60 days.

Drug Establishments (DRLS)

Drug establishment registrations are updated through the Drug Registration and Listing System (DRLS). Annual registration renewal occurs between October 1 and December 31 each year. If you change your U.S. Agent outside the renewal window, submit an amendment through DRLS as soon as possible.

Device Establishments (FURLS)

Device establishments use the FDA Unified Registration and Listing System (FURLS). As with drugs, the annual registration period runs October 1 through December 31. The MDUFA V annual registration fee (currently $7,653 for FY2026) must be paid before your registration — including any U.S. Agent changes — takes effect.

Cosmetics Facilities (Cosmetics Direct)

MoCRA cosmetics registrations use FDA's Cosmetics Direct system. You can update your U.S. Agent at any time. Foreign facilities must maintain an active U.S. Agent to keep their registration in good standing per FD&C Act Section 607(a)(3).

Avoiding Coverage Gaps

The most important consideration when changing your U.S. Agent is ensuring continuity. Here are best practices:

• Overlap your agents: Have your new agent ready before you terminate the old one. Ideally, coordinate the switch so both agents are aware of the transition date.
• Notify your old agent: Professional courtesy and contractual obligations may require you to give your current agent advance notice.
• Get written confirmation: Obtain a signed confirmation letter from your new agent before submitting the FDA update.
• Update all related registrations: If you have multiple FDA registrations (e.g., food and cosmetics), update the U.S. Agent for each one.

What to Look for in Your New U.S. Agent

When selecting a new U.S. Agent, evaluate candidates on the following criteria:

• Responsiveness: FDA may contact your U.S. Agent at any time, including emergencies. Your agent should be reachable by phone and email during business hours.
• Multi-category coverage: If your facility produces both food and cosmetics (or drugs and devices), choose an agent that can serve across all categories to simplify management.
• Transparent pricing: Avoid agents with hidden fees, auto-renewal traps, or charges for basic FDA communications.
• Experience and reputation: Look for agents with established track records and positive reviews from other foreign facilities.

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