How to Switch Your FDA US Agent: Complete Guide

Why Companies Switch US Agents

Under 21 CFR 1.227 (food), 21 CFR 207.40 (drugs), 21 CFR 807.40 (devices), and MoCRA Section 3503 (cosmetics), every foreign establishment registered with FDA must designate a US Agent who resides or maintains a place of business in the United States. The agent serves as FDA's primary point of contact.

Common reasons companies switch their US Agent include:

• Poor responsiveness: The current agent is slow to forward FDA communications, which can result in missed deadlines or enforcement actions
• High or opaque fees: Some agents charge premium rates or add hidden fees for routine services like forwarding letters
• Missing compliance tools: Legacy agents may not provide digital dashboards, renewal alerts, or documentation tracking
• Business changes: The agent's firm dissolved, the contact person left, or the company wants to consolidate all product categories under one agent
• Expansion: The company added new product categories (e.g., starting cosmetics distribution alongside food) and wants a single agent for all categories

Step-by-Step: Changing Your Food Facility US Agent (FFRM)

Food facility US Agent changes are made through FDA's Food Facility Registration Module (FFRM), accessible via the FDA Industry Systems (FIS) portal. The process is governed by 21 CFR 1.227(b).

1. Engage your new agent: Before making any changes in FFRM, ensure your new US Agent has agreed to serve in writing. FDA requires the agent to confirm acceptance.
2. Log into FIS/FFRM: The facility owner or operator must access FFRM at https://www.access.fda.gov using their existing account.
3. Select your facility registration: Navigate to your active food facility registration and choose the option to update it.
4. Update US Agent information: Replace the current agent's name, address, phone number, and email with your new agent's information.
5. Submit the update: After reviewing, submit the amended registration. FDA processes the change and issues an updated confirmation.
6. Verify the change: Confirm that the new agent information is reflected in your registration records.

Food facility US Agent changes can be made at any time during the year, not just during the biennial renewal window. There is no FDA fee for updating your agent.

Step-by-Step: Changing Drug/Device US Agent (FURLS/DRLS)

Drug establishment US Agent changes are made through the FDA Unified Registration and Listing System (FURLS) via the Drug Registration and Listing System (DRLS). Device establishments use the same FURLS portal but access the Device Registration and Listing Module (DRLM). The requirement is codified at 21 CFR 207.40 (drugs) and 21 CFR 807.40 (devices).

1. Confirm new agent acceptance: Your new agent must agree to represent your establishment and be available during normal US business hours.
2. Access FURLS: Log into your account at https://www.access.fda.gov and navigate to DRLS or DRLM.
3. Locate your establishment record: Find your active registration using your FEI (FDA Establishment Identifier) number.
4. Amend the US Agent fields: Update the agent name, company, address, phone, and email fields.
5. Submit and confirm: Submit the amendment. Drug and device agent changes take effect upon FDA processing, typically within 1–3 business days.

For annual registration renewals (October 1–December 31), you can update your US Agent as part of the renewal process.

Step-by-Step: Changing Cosmetics US Agent

Under MoCRA (Public Law 117-328, Section 3503), cosmetics facility registrations and product listings are submitted through FDA's Structured Product Labeling (SPL) system at the Cosmetics Direct portal. To change your US Agent:

1. Prepare updated SPL submission: Cosmetics registrations use SPL format. Your new agent's information must be included in the facility registration SPL.
2. Submit amended registration: Upload the updated SPL file through FDA's Cosmetics Direct system. The submission replaces the previous agent information.
3. Confirm acceptance: The new agent should have documentation confirming their role as your designated US Agent for cosmetics.

Because cosmetics registration under MoCRA is relatively new (effective December 29, 2022), many companies are setting up US Agent arrangements for the first time. Switching agents early in the program is common.

Timeline and Coverage Gap Risks

To avoid gaps, follow this order: (1) secure your new agent's acceptance, (2) update FDA systems, (3) notify your old agent after the change is confirmed. Do not notify your old agent first, as they may immediately stop services.

Processing times vary: food facility changes are typically reflected within 24–48 hours, drug/device changes within 1–3 business days, and cosmetics changes within 5–10 business days.

What to Look for in a New US Agent

Not all US Agent services are equal. When evaluating a new agent, consider these factors:

• Availability: FDA requires the agent to be reachable during normal US business hours (21 CFR 1.227(b)(3) for food). Look for agents with extended or 24/7 availability.
• Digital communication tools: A compliance dashboard that logs all FDA correspondence, tracks deadlines, and provides real-time notifications
• Transparent pricing: Flat-rate annual fees with no per-communication surcharges or hidden costs
• Multi-category support: If you register food, drugs, devices, or cosmetics, having one agent across all categories simplifies management
• Same-day confirmation letters: When shipments are on hold, you need proof of US Agent designation immediately, not in 3 business days
• Renewal reminders: Automatic alerts for biennial (food) and annual (drug/device) renewal deadlines

Switching to Assurentry — Same-Day Letters

Assurentry makes the switch seamless. Our onboarding process handles the FDA system updates for you: