An 8-Step Guide to Selecting a US FDA agent for Your Company

A U.S. FDA agent is a designated representative required for foreign companies that manufacture, process, or distribute FDA-regulated products. These products, such as medical devices, drugs, or food, should be intended for import into the United States. We have provided a detailed step-by-step guide to selecting a suitable US FDA agent.

Who needs a U.S. Agent?

Any foreign establishment involved in FDA-regulated activities (e.g., manufacturing or processing) that wants to import products into the U.S. must appoint a U.S. Agent.

Type of industries that mandatorily require US FDA agent

Any foreign establishment that manufactures, processes, or distributes FDA-regulated products for import into the U.S. must appoint a U.S. Agent. The US FDA agent recruitment is mandatory for the following types of facilities that wish to export to the USA.

• Drug manufacturers
• Medical device manufacturers and exporters
• Cosmetic manufacturers
• Food manufacturers and re-packers
• Nutraceutical manufacturers
• API manufacturers
• Sterilization facilities etc.

Note: Only one U.S. Agent can be designated per foreign establishment. Additionally, the agent may also serve as the official correspondent, although this is optional. Notably, failure to designate a U.S. Agent can delay or block product entry into the U.S. market.

4 Key responsibilities of a U.S. Agent

We have highlighted the responsibilities of a U.S. Agent.

1. Liaison with the FDA: Acts as the primary point of contact between the FDA and the foreign company.
2. Communication: Handles regulatory correspondence, including inspection notices and compliance actions.
3. Registration support: Assists with establishment registration and product listing via the FDA’s Unified Registration and Listing System (FURLS) system.
4. Emergency contact: Must be available for FDA inquiries, especially in urgent situations.

How to select a suitable US FDA agent?

Foreign companies must carefully evaluate the credentials of the US FDA Agent before appointing them as your company representative, as the agent plays a vital role in regulatory compliance. Selecting an agent suitable for your organisation and product can be a difficult task. Hence, we have provided a step-by-step guide to help you appoint a US agent for your organisation.

1. Understand the role: Appointing a U.S. Agent is not just a regulatory formality. They are your regulatory liaison with the FDA. Their responsibilities include receiving FDA communications (e.g., inspection notices, compliance actions)and assisting with registration and listing via the FURLS system. Additionally, they respond to FDA inquiries in emergencies. Moreover, they support import logistics and regulatory troubleshooting.
2. Define your needs: Before selecting the US FDA agent, define what you expect beyond the minimum FDA requirements. Do you need help with device listings, label reviews, or inspection preparation? Will they support multi-market submissions or IVD-specific pathways? Do you want strategic input on risk mitigation, CAPA, or audit readiness? Are they capable of providing this support?
3. Evaluate credential: The agent must be a lawfully registered firm in the USA. Look for agents with regulatory expertise in your product category (e.g., IVDs, Class II devices). Additionally, they should have experience with FDA inspections and enforcement actions. Familiarity with ISO 13485, ISO 14971, and U.S. QSR requirements is a plus point. Digital-first capabilities (e.g., eSTAR, structured content, dashboarding) are a requirement.
4. Assess communication and responsiveness: Your agent must be reachable and proactive. Do they offer 24/7 availability for FDA emergencies? Can they handle time-sensitive queries during inspections or detentions? Are they fluent in technical and regulatory language?
5. Verify legal and operational standing: It is important to verify the legal and operational standing of the agent. Is the agent physically located in the U.S.? Does the agent have a valid business registration? Are there any conflicts of interest (e.g., representing competitors or having compliance issues)?
6. Review service agreements: Key contract elements to include scope of services (basic vs. extended), confidentiality and data handling, fees and renewal terms, and termination clauses and liability limits.
7. Designate in FURLS: Upon selecting the US agent, submit their contact details in the FDA’s Unified Registration and Listing System (FURLS).Ensure accuracy of the details submitted. This is the official record used by FDA for all communications.
8. Maintain the relationship: Treat your U.S. Agent as a strategic partner. Share updates on product changes, recalls, or regulatory shifts. Include them in mock audits or compliance reviews. Periodically reassess their performance and alignment with your goals.

A comprehensive checklist for appointing US agent

We have prepared a comprehensive checklist to help you appoint a US FDA agent. 

1. Regulatory Expertise

• Experience with FDA device registration (FURLS, eSTAR)  
• Familiarity with ISO 13485, ISO 14971, and QSR 
• Knowledge of IVD classification and regulatory pathways               
• Track record with FDA inspections and enforcement actions                        
• Multi-market regulatory alignment

2. Operational capabilities

• U.S. physical presence and valid business registration       
• 24/7 availability for FDA emergencies      
• Structured communication protocols (email, dashboard, ticketing)            
• Support for registration, listing, and updates        
• Ability to act as official correspondent (if needed)

3. Digital and strategic support

• eSTAR and digital-first submission support                           
• Risk-based guidance on CAPA, recalls, and adverse events                            
• Strategic input on regulatory timing and market entry     
• Templates or SOPs for FDA interactions  
• Secure data handling and confidentiality protocols

4. Service agreement review

• Clear scope of services
• Transparent fee structure             
• Defined renewal and termination terms                
• Liability and indemnity clauses   
• NDA or confidentiality agreement included

5. Performance and suitability

• Responsive and proactive communication                            
• Cultural and language alignment               
• References or client testimonials              
• Willingness to participate in mock audits                             
• Alignment with your compliance philosophy

This checklist will guide you in your US Agent selection process.

What is the process of a US agent appointment?

1. Select a qualified agent: The agent must reside or operate a business in the U.S. and be physically present (not a mailbox or virtual office). They should be capable of receiving FDA communications and responding to inquiries.
2. Gather required information: Collate information on the US FDA agent. You will need to collect and submit the agent’s full name, business address in the U.S., telephone and fax numbers, and email address.
3. Submit via FURLS: Log into the FDA Unified Registration and Listing System (FURLS). Then, during establishment registration, enter the U.S. Agent’s details. The agent must confirm acceptance electronically via FURLS.
4. Maintain and update: Keep the agent’s contact information current. Update the designation if you change agents or business structure. Renew annually as part of establishment registration
5. Legal and regulatory implications: The U.S. Agent is authorized to receive inspection notices, respond to FDA inquiries, and facilitate regulatory actions (e.g., recalls, detentions). They do not assume legal liability unless specified in your contract.

Hence, appointing an US agent is a mandatory requirement for any foreign establishment intending to import products for sale and distribution in US. This agent will act as a liaison between the foreign company and FDA. Additionally, they will handle all regulatory communications with the FDA. In this blog, we have provided a step-by-step guide for selecting and appointing a suitable US FDA agent. For any queries on US FDA regulatory requirements, feel free to email at [email protected] or call/Whatsapp on 9996859227.

FAQs

Is US FDA Agent a mandatory requirement for medical device importers?

All foreign establishments importing and distributing medical devices intended for the US market need to appoint US FDA Agents.

Is the US Agent issued Certificate valid and is it authorized by the FDA?

No, FDA Agent Certificate is not authorized by the FDA.

Is the US Agent appointed by FDA?

No, the US Agent is independent. They are not approved or recognized by FDA authorities.