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Top 10 Questions About FDA Registered Agents — Answered

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Use this 8-step FDA compliance checklist to avoid costly shipment delays and ensure your products enter the U.S. smoothly.

If you’re a foreign manufacturer exporting FDA-regulated products to the U.S., appointing a registered agent is one of your first compliance requirements. But what exactly does this role involve — and how does it affect your business?

We’ve compiled the 10 most common questions international companies ask about FDA registered agents, with in-depth answers to help you make informed decisions.

1. What does an FDA registered agent do?

An FDA registered agent acts as your official U.S. point of contact with the Food and Drug Administration. Their primary role is to receive and forward FDA communications, including:

  • Notices of inspection
  • Regulatory correspondence
  • Compliance updates or enforcement actions
  • Questions about your facility registration or product listings

Without an agent, the FDA cannot legally complete your establishment registration, which can stop your products from entering the U.S. market.

2. Is the agent legally responsible for compliance?

No. Compliance responsibility always remains with the manufacturer.
The agent does not:

  • Guarantee your product is compliant
  • Take on liability for manufacturing practices
  • Replace your quality or regulatory team

Instead, the agent ensures you never miss a critical FDA communication that could affect your business.

3. Do I need an agent if I already have a U.S. distributor?

Not necessarily. Some companies designate their distributor as their FDA agent. However, this can create conflicts of interest:

  • Distributors may not prioritize regulatory notices.
  • If you change distributors, you must also change your FDA agent.
  • Many distributors decline this responsibility because it carries administrative obligations.

For these reasons, many manufacturers prefer appointing an independent professional agent to keep roles clear.

4. Can I change my agent later?

Yes. You may update or change your FDA registered agent at any time. The process involves:

  1. Submitting updated information through the FDA’s FURLS (FDA Unified Registration and Listing System).
  2. Ensuring both the old and new agents are formally documented.
  3. Keeping records of the appointment for your own compliance files.

There are no penalties for switching agents, but it’s best to avoid gaps in representation.

5. Does the FDA certify or approve registered agents?

No. The FDA does not endorse or certify specific agents. This means the responsibility falls on you to:

  • Verify the agent has a valid U.S. presence.
  • Ensure they have a proven track record of responsiveness.
  • Review their service agreement to confirm they will fulfill FDA communication obligations.

This is why choosing an experienced agent — not just a U.S. mailing address — is so important.

6. How much does an FDA registered agent cost?

Fees vary widely depending on service scope. Typical costs range from a few hundred dollars to several thousand dollars annually.

Factors affecting cost include:

  • Number of facilities you register
  • Whether you need basic service only (receiving/forwarding FDA notices) or expanded support (regulatory consulting, compliance monitoring, annual renewals)
  • Speed of onboarding and level of availability

Professional registered agent services are usually much more cost-effective than relying on a distributor or law firm.

7. What happens if my agent misses a notice?

This can be serious. If an agent fails to forward an FDA communication:

  • Shipments may be delayed or refused at U.S. ports.
  • Your facility could miss deadlines for corrective actions.
  • The FDA may consider your registration invalid.

That’s why responsiveness is the #1 quality to look for in an agent. A reliable partner prevents costly interruptions.

8. Can one agent represent multiple facilities?

Yes. A single registered agent can represent multiple establishments, provided all facilities are listed correctly during registration. This is common for:

  • Contract manufacturers with several sites
  • Companies with multiple product categories (e.g., medical devices + dietary supplements)

Make sure your agent can handle the administrative volume if you operate at scale.

9. Is the agent’s information publicly available?

Yes. The agent’s name and U.S. address appear in the FDA’s registration database, which is accessible to regulators and, in some cases, the public. This transparency is intentional, so the FDA always has a reliable contact.

For some companies, this visibility is also beneficial, as it signals compliance readiness to U.S. partners.

10. What makes a good FDA registered agent?

The best FDA registered agents share three qualities:

  1. Availability — They must respond quickly to time-sensitive FDA requests.
  2. Experience — They understand FDA communication protocols and industry-specific challenges.
  3. Reliability — They consistently forward notices without delay, minimizing compliance risks.

Bonus: Many professional agents also provide regulatory guidance or help coordinate inspections, offering added value beyond the basic requirement.

Appointing a U.S. FDA registered agent is more than just a box to tick — it’s the foundation of your U.S. compliance. Choosing the right partner means fewer delays, fewer risks, and a smoother path into the American market.

At FDA Entry, we prioritize personal attention to your company. Contact us today for a consultation.

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