Is there an official FDA U.S. Agent list?

No, there is no official FDA U.S. Agent list or registry. FDA does not maintain a public directory of U.S. Agents. Any company claiming to be on an 'official FDA list' is making a false claim. FDA only requires that foreign establishments designate a U.S. Agent during registration, but does not certify, accredit, or maintain a list of U.S. Agents.

Can U.S. Agents be FDA accredited or certified?

No. FDA does not accredit, certify, or license U.S. Agents. The U.S. Agent role is simply a designation requirement under 21 CFR 807.40 for foreign establishments. Any claims of 'FDA accreditation' or 'FDA certification' for U.S. Agent services are false and misleading.

What are the actual FDA requirements for a U.S. Agent?

Under 21 CFR 807.40, a U.S. Agent must: (1) be physically located in the United States, (2) have a valid U.S. address (not a PO box), (3) be available during business hours to receive FDA communications, and (4) be authorized to act on behalf of the foreign establishment. There are no certification, accreditation, or licensing requirements.

How can I verify if a U.S. Agent provider is legitimate?

Verify that the provider: (1) has a physical U.S. address (not a PO box or virtual mailbox), (2) can provide references from existing clients, (3) has experience with FDA registration processes, (4) responds promptly to inquiries, and (5) does not make false claims about FDA accreditation or certification. Check their business registration and physical location.

Where can I find verified U.S. Agent providers?

While there is no official FDA list, you can find verified providers through regulatory service directories, industry associations, and comparison platforms like Cruxi. Look for providers with proven track records, client testimonials, and transparent service descriptions. Always verify claims independently.

FDA U.S. Agent List: The Reality

There is no official FDA U.S. Agent list. Learn why fake accreditation claims are misleading and compare verified providers from Cruxi's vetted directory.

✓ No Official List Exists ✓ Beware Fake Claims ✓ Verified Providers

⚠️ Important: There Is No Official FDA U.S. Agent List

The FDA does not maintain a public directory, registry, or list of U.S. Agents. Any company claiming to be on an "official FDA list" or advertising "FDA-accredited" or "FDA-certified" U.S. Agent services is making false claims. The U.S. Agent role is simply a designation requirement—not a certification or accreditation program.

Why There Is No Official FDA U.S. Agent List

Under 21 CFR 807.40, foreign medical device establishments must designate a U.S. Agent during registration. However, FDA does not:

Maintain a public registry or directory of U.S. Agents
Certify, accredit, or license U.S. Agents
Verify U.S. Agent qualifications beyond basic requirements
Publish lists of approved or recommended U.S. Agents
Endorse any specific U.S. Agent providers

The U.S. Agent designation is a regulatory requirement, not a certification program. FDA's role is limited to ensuring that foreign establishments designate someone who meets the basic requirements: physical U.S. location, valid address (not a PO box), and availability during business hours.

Common Fake Claims About FDA Accreditation

Many U.S. Agent providers make misleading claims to appear more legitimate. Here are the most common false statements and why they're problematic:

False Claim	Reality	Why It's Misleading
"FDA-Accredited U.S. Agent"	FDA does not accredit U.S. Agents	Implies FDA endorsement or quality verification that doesn't exist
"FDA-Certified U.S. Agent"	No FDA certification program exists	Suggests formal FDA approval or qualification process
"On the Official FDA List"	No official list exists	Creates false sense of legitimacy and FDA endorsement
"FDA-Registered U.S. Agent"	U.S. Agents are not registered separately	Confuses establishment registration with U.S. Agent designation
"FDA-Approved U.S. Agent"	FDA does not approve U.S. Agents	Implies FDA has evaluated and approved the provider

What FDA Actually Requires: According to FDA guidance, a U.S. Agent must:

Be physically located in the United States
Have a valid U.S. street address (PO boxes are prohibited)
Be available during business hours to receive FDA communications
Be authorized to act on behalf of the foreign establishment

That's it. There are no certification exams, accreditation processes, or quality standards beyond these basic requirements.

How to Verify a Legitimate U.S. Agent Provider

Since there's no official list, how can you identify legitimate providers? Here's what to look for:

✓ Legitimate Indicators

Physical U.S. Address: Verify they have a real office address (not a PO box or virtual mailbox)
Business Registration: Check state business registration records
Client References: Ask for references from existing clients
Experience: Look for providers with years of experience and proven track records
Transparency: Legitimate providers are transparent about services and pricing
Responsiveness: They respond promptly to inquiries and provide clear information

⚠️ Red Flags to Avoid

Claims of "FDA accreditation" or "FDA certification"
References to being on an "official FDA list"
PO box addresses or virtual mailboxes
Unusually low prices that seem too good to be true
Pressure tactics or high-pressure sales
Lack of transparency about services or pricing
No verifiable business address or contact information

Cruxi Vetted FDA U.S. Agent Providers

While there is no official FDA list, Cruxi maintains a directory of verified U.S. Agent providers. These providers have been vetted for:

Valid physical U.S. addresses (verified, not PO boxes)
Business registration and legitimacy
Experience with FDA registration processes
Client testimonials and references
Transparent service descriptions
No false accreditation claims

Important: These providers are not "FDA-approved" or "FDA-accredited"—they are simply verified providers that meet basic requirements and have demonstrated reliability. Always do your own due diligence before selecting a U.S. Agent.

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