Transfer Your FDA Registration to a New U.S. Agent
If your current U.S. Agent is unresponsive, inactive, or no longer meets your compliance needs, FDA Registration Assistance can take over the designation quickly — ensuring your FDA registration stays active and FDA communications are handled without interruption.
Common Reasons to Change Your FDA U.S. Agent
The U.S. Agent is FDA's primary domestic contact for your facility. If that relationship breaks down, your FDA compliance is at risk. These are the most common reasons foreign facilities transfer to a new U.S. Agent:
Your current agent doesn't respond to FDA communications, emails, or phone calls — leaving your facility without a functioning domestic contact.
Your current agent doesn't alert you to Biennial Renewal windows or annual Drug/Device registration renewal deadlines — putting your registration at risk of lapsing.
Your U.S. Agent went out of business or is no longer reachable — leaving the wrong contact information on file with FDA.
Your current agent is a name on a form but provides no actual regulatory support, label review, or compliance guidance when you need it.
You are moving all FDA compliance services — registration, FSVP, label review, MoCRA — to a single provider and need your U.S. Agent to match.
You need one U.S. Agent for multiple FDA registrations across different product categories or facilities — all managed under one firm.
U.S. Agent Transfer by FDA Registration Type
The U.S. Agent transfer process follows the same core steps across all registration types — but each type has its own FDA system and renewal schedule. FDA Registration Assistance handles transfers for all four registration types:
| Registration Type | FDA System | Renewal Schedule | Transfer Timeline |
|---|---|---|---|
| Food Facility Registration | FURLS (Unified Registration and Listing System) | Biennial — Oct 1 – Dec 31, even-numbered years | 24–48 hours |
| Drug Establishment Registration | FDA Drug Registration & Listing System | Annual — Oct 1 – Dec 31 | Per system processing |
| Medical Device Establishment Registration | FDA Device Registration & Listing Module (DRLM) | Annual — Oct 1 – Dec 31 | Per system processing |
| MoCRA Cosmetic Registration | FDA Cosmetics Direct | Renewal required; product listing updates ongoing | Per system processing |
How the U.S. Agent Transfer Process Works
FDA Registration Assistance handles the entire transfer from start to finish. Here is the step-by-step process:
Contact FDA Registration Assistance
Provide your FDA registration number, facility name, and registration type (Food Facility, Drug Establishment, Medical Device, or MoCRA cosmetic). No prior approval from your current agent is needed — the transfer is controlled by your facility, not your current agent.
We Review Your Existing Registration
FDA Registration Assistance reviews your current registration record in FDA's system to confirm all facility details — legal name, physical address, product categories, DUNS Number (for food facilities), and current registration status. This ensures the transfer is applied to the correct, accurate record.
We Accept the U.S. Agent Designation
FDA Registration Assistance formally accepts the U.S. Agent designation for your facility and updates the registration record in FDA's system. For Food Facility Registrations, this is completed in FURLS. For Drug and Device registrations, the update is made in the respective FDA registration system.
Transfer Confirmed
Once the update is reflected in FDA's system, FDA Registration Assistance confirms the transfer is complete. Your registration number remains unchanged. FDA Registration Assistance is now the official U.S. Agent on record and begins receiving any FDA communications directed to your facility.
Ongoing U.S. Agent Support
After the transfer, FDA Registration Assistance provides ongoing U.S. Agent services — receiving and forwarding FDA communications, managing renewal deadlines (Biennial Renewal for food, annual renewals for drug and device), MoCRA product listing maintenance, and compliance guidance as needed.
Why Companies Choose FDA Registration Assistance as Their New U.S. Agent
Responsive — Not Just a Name on a Form
Many U.S. Agent providers are listing services — they put their name on your registration and do nothing else. FDA Registration Assistance actively responds to FDA communications, answers compliance questions, and provides real regulatory support throughout the year.
Renewal Management
FDA Registration Assistance tracks Biennial Renewal deadlines for Food Facility Registrations and annual renewal deadlines for Drug and Device Establishment Registrations — proactively notifying you and managing renewals so your registration never lapses.
All Registration Types
One firm handles U.S. Agent services for all four FDA registration types — Food Facility, Drug Establishment, Medical Device, and MoCRA cosmetic. No need to use different agents for different product lines.
24–48 Hour Transfer
Food Facility Registration U.S. Agent transfers are typically completed within 24 to 48 hours after facility information is confirmed. Fast transfer minimizes any gap in agent coverage — especially important if your current agent is already inactive.
1,000+ Clients, 135+ Countries
FDA Registration Assistance currently serves as U.S. Agent for facilities across 135+ countries in every FDA-regulated product category. The firm's breadth of experience means your compliance needs are well understood regardless of where you are located or what you produce.
BBB Accredited
FDA Registration Assistance is accredited by the Better Business Bureau — independently verifying our commitment to professional, ethical, and transparent business practices. You can trust that your U.S. Agent designation is in verified, accountable hands.
Ready to Transfer Your FDA U.S. Agent?
Contact FDA Registration Assistance today and provide your FDA registration number and facility details. Our team will review your existing registration and complete the U.S. Agent transfer quickly and accurately — without disrupting your FDA compliance status.
Email info@fdaregistrationassistance.com or call +1 (928) 275-8333. Most Food Facility Registration transfers completed within 24–48 hours.
Frequently Asked Questions — Transferring Your FDA U.S. Agent
1. Can a foreign facility change its FDA U.S. Agent?
Yes. Foreign FDA-registered facilities can update their U.S. Agent designation at any time. The facility's registration number does not change — only the agent contact information is updated in FDA's registration system. There is no FDA filing fee to change a U.S. Agent.
2. What is a U.S. Agent and why is one required?
A U.S. Agent is a person or company physically located in the United States that acts as FDA's official domestic point of contact for a foreign FDA-registered facility. The U.S. Agent receives FDA communications on behalf of the facility, assists with FDA inspections, and maintains the relationship between the foreign facility and FDA. U.S. Agent designation is required for FDA Food Facility Registration, Drug Establishment Registration, Medical Device Establishment Registration, and MoCRA cosmetic facility registration.
3. Does changing the U.S. Agent affect my FDA registration number?
No. Your FDA registration number remains the same when you change your U.S. Agent. Only the agent contact information is updated in FDA's system. The registration itself — including the facility name, address, product categories, and registration number — is not affected by the agent change.
4. Why do companies transfer to a new FDA U.S. Agent?
The most common reasons include: the current agent is unresponsive to FDA communications or facility inquiries; the current agent does not assist with Biennial Renewal reminders or registration updates; the current agent does not provide broader FDA compliance guidance; the company is consolidating FDA compliance services under a single provider; or the current agent has closed operations or is no longer reachable.
5. What happens if my U.S. Agent stops responding or goes out of business?
If a U.S. Agent becomes unreachable, your FDA registration still shows them as the official contact on file. FDA could attempt to contact your facility through that outdated information and receive no response — creating compliance risk. If your current U.S. Agent is unresponsive, transferring to a new agent should be treated as an urgent matter. FDA Registration Assistance can complete food facility transfers within 24–48 hours.
6. How long does it take to transfer a U.S. Agent?
Once all required facility information is confirmed and the new U.S. Agent designation is executed, the update is typically reflected in FDA's system within 24 to 48 hours for Food Facility Registrations. Drug Establishment and Medical Device Establishment Registration updates follow their respective system timelines. FDA Registration Assistance moves quickly on transfers to minimize any gap in agent coverage.
7. How do I transfer my FDA Food Facility Registration to a new U.S. Agent?
To transfer a U.S. Agent for FDA Food Facility Registration, the registration record in FDA's Unified Registration and Listing System (FURLS) must be updated. FDA Registration Assistance reviews your current registration, confirms facility details, accepts the U.S. Agent designation, and updates the record. The entire process is typically completed within 24 to 48 hours once your facility information is confirmed.
8. How do I transfer my Drug Establishment Registration to a new U.S. Agent?
Drug Establishment Registration U.S. Agent transfers require updating the agent designation in FDA's drug registration system. FDA Registration Assistance reviews your current Drug Establishment Registration, confirms your registration details, and processes the U.S. Agent update. Drug Establishment Registrations must also be renewed annually between October 1 and December 31.
9. How do I transfer my Medical Device Establishment Registration to a new U.S. Agent?
Medical Device Establishment Registration U.S. Agent transfers require updating the agent designation in FDA's Device Registration and Listing Module (DRLM). FDA Registration Assistance handles the update while ensuring your Device Listing remains accurate and your annual renewal obligations are tracked.
10. Can cosmetic facilities under MoCRA transfer their U.S. Agent?
Yes. Foreign cosmetic facilities registered under the Modernization of Cosmetics Regulation Act (MoCRA) can update their U.S. Agent designation. FDA Registration Assistance handles MoCRA U.S. Agent transfers and manages ongoing MoCRA compliance including product listing updates and facility registration maintenance.
11. Does the current U.S. Agent need to approve the transfer?
No. The transfer of a U.S. Agent designation is controlled by the foreign registered facility, not by the current agent. The facility has the right to update its agent designation at any time without requiring the current agent's approval. FDA Registration Assistance formally accepts the new designation as part of the transfer process.
12. Will FDA contact the new U.S. Agent after the transfer?
Yes. Once the U.S. Agent update is reflected in FDA's system, FDA Registration Assistance becomes the official domestic contact for your facility. Any FDA communications, inspection notices, Import Alerts, or regulatory inquiries directed to your facility will be received by FDA Registration Assistance and forwarded to you promptly.
13. Does my facility need to re-register with FDA when changing U.S. Agents?
No. Changing your U.S. Agent does not require re-registration. It is a registration update — not a new registration. Your existing registration number, facility details, and product categories are preserved. Only the U.S. Agent contact information is changed.
14. Can multiple facilities use the same U.S. Agent?
Yes. A single U.S. Agent can represent multiple FDA-registered facilities. Many companies designate the same U.S. Agent for multiple manufacturing or processing locations. FDA Registration Assistance serves as the U.S. Agent for facilities across multiple product categories and countries simultaneously.
15. Is there a fee to transfer to a new U.S. Agent?
FDA does not charge a filing fee to update a U.S. Agent designation. The cost is the service fee charged by the new U.S. Agent for processing the transfer and providing ongoing agent services. Contact FDA Registration Assistance for information about U.S. Agent service fees.
16. What information does FDA Registration Assistance need to process the transfer?
To process a U.S. Agent transfer, FDA Registration Assistance typically needs: your FDA registration number, facility legal name and physical address, registration type (Food Facility, Drug Establishment, Medical Device, or MoCRA cosmetic), DUNS Number for Food Facility registrations, and primary facility contact information. FDA Registration Assistance confirms all details against FDA records before executing the transfer.
17. What are the risks of having an inactive or unresponsive U.S. Agent?
An inactive or unresponsive U.S. Agent creates significant compliance risk. FDA uses the U.S. Agent as the domestic contact for inspection scheduling, Import Alert communications, safety notices, and regulatory correspondence. If FDA sends a communication and receives no response from the agent, the facility may be considered non-cooperative — potentially leading to enforcement action, Import Alert placement, or shipment detention.
18. Does transferring the U.S. Agent affect the Biennial Renewal for Food Facility Registration?
No. Transferring your U.S. Agent does not affect the Biennial Renewal obligation or timeline. Food Facility Registration must still be renewed between October 1 and December 31 of every even-numbered year regardless of agent changes. FDA Registration Assistance tracks Biennial Renewal deadlines and manages renewals for all facilities it serves as U.S. Agent.
19. Can I transfer my U.S. Agent before the Biennial Renewal window?
Yes. U.S. Agent transfers can be completed at any time — before, during, or after the Biennial Renewal window. Completing the transfer before the renewal window opens ensures FDA Registration Assistance is in place to manage the Biennial Renewal on your behalf. If your current agent is unreliable, transferring well in advance is strongly recommended.
20. What if my FDA registration has lapsed — can I still transfer the U.S. Agent?
If your FDA registration has lapsed — for example due to a missed Biennial Renewal — the registration needs to be reinstated before a U.S. Agent transfer can be completed. FDA Registration Assistance handles both registration reinstatement and U.S. Agent transfer in a single process. Contact us to assess the current status of your registration.
21. How does FDA Registration Assistance provide ongoing U.S. Agent support after the transfer?
After the transfer, FDA Registration Assistance provides ongoing U.S. Agent services including: receiving and promptly forwarding all FDA communications; tracking and managing Biennial Renewal and annual renewal deadlines; assisting with registration updates when facility details change; responding to FDA inquiries on your behalf; and providing compliance guidance on FDA registration-related matters.
22. Can FDA Registration Assistance serve as U.S. Agent for all FDA registration types?
Yes. FDA Registration Assistance provides U.S. Agent services for all four registration types — FDA Food Facility Registration, Drug Establishment Registration, Medical Device Establishment Registration, and MoCRA cosmetic facility registration. The firm serves as U.S. Agent for 1,000+ facilities across 135+ countries.
23. Will my current U.S. Agent be notified when I transfer?
FDA does not formally notify the previous agent when a change is made. The previous agent's designation is simply replaced in FDA's system once the new agent is in place. No approval or notification from the previous agent is required.
24. How do I get started with transferring my U.S. Agent to FDA Registration Assistance?
Contact FDA Registration Assistance at info@fdaregistrationassistance.com or call +1 (928) 275-8333. Provide your FDA registration number, facility name, and registration type. Our team will review your existing registration, confirm the details, and initiate the U.S. Agent transfer. Most food facility transfers are completed within 24 to 48 hours.
25. Why choose FDA Registration Assistance as your new U.S. Agent?
FDA Registration Assistance is a BBB-accredited U.S.-based FDA compliance firm with 15+ years of experience serving 1,000+ companies across 135+ countries. Unlike automated filing services, FDA Registration Assistance provides direct access to experienced regulatory specialists, proactive renewal management, prompt response to FDA communications, and comprehensive compliance guidance across all FDA registration types. Transferring to FDA Registration Assistance means a responsive, knowledgeable U.S. Agent partner — not just a name on a form.
