The current price and the scope it buys
As of October 27, 2026, FDA Entry Point charges $295 per year for U.S. Agent service for foreign food and cosmetic facilities. The published annual price is $395 for foreign drug and medical-device establishments. Each fee covers the continuing agent relationship, while registration, product, label, shipment, and technical-submission work is priced separately. See FDA Entry Point pricing.
The annual fee pays for standing coverage: FDA has a U.S.-based contact who can receive communications, escalate urgent matters, explain what a notice requires, coordinate inspection communications, and track upcoming renewal requirements. It does not buy an unlimited compliance retainer or automatically include every filing connected to the facility.
This structure is a strong fit for a foreign manufacturer without a dedicated U.S. regulatory employee, or for a company replacing an agent that forwarded notices without explaining deadlines or coordinating the next action. FDA treats the U.S. Agent as a working communications link, not a decorative address. For foreign food facilities, information delivered to the agent can be treated as delivered to the facility itself. FDA food facility guidance defines that role.
Every item included in the annual U.S. Agent fee
| Line item | Included treatment | Where the boundary sits |
|---|---|---|
| U.S. Agent designation | FDA Entry Point agrees to serve as the foreign facility’s U.S.-based agent and completes the applicable designation or confirmation workflow. | Facility or establishment registration preparation and submission are separate services. |
| Official FDA correspondence | Routine inquiries, urgent notices, regulatory correspondence, and other communications sent to the designated agent are received and forwarded to the client. | No additional fee is triggered merely because FDA sends a routine communication. |
| Explanation and triage | The client receives a plain-English explanation of what the communication concerns, its stated deadline, and the immediate next action. | A new filing, formal response package, corrective-action project, detention defense, import-alert petition, or legal representation requires separate scope. |
| Urgent escalation | Recall notices, public-health alerts, inspection requests, and other time-sensitive communications are escalated to the client’s designated contacts. | Laboratory work, product recovery, recall execution, or a substantive regulatory defense is not part of routine agent coverage. |
| Inspection liaison work | FDA Entry Point helps coordinate scheduling, communications, and logistics between FDA and the foreign facility. | A mock inspection, quality-system remediation, document review, or Form 483 response is a separate engagement. |
| Renewal tracking | The relationship includes monitoring applicable renewal dates and coordinating reminders so the facility can act before a deadline. | Preparing and submitting the facility or establishment renewal remains separately priced. |
| Service questions | FDA Entry Point publishes a response commitment of within 24 business hours for U.S. Agent and compliance inquiries. | FDA’s own processing, confirmation, or review time remains outside the provider’s control. |
| Ordinary shipment activity | The annual agent fee does not increase simply because the facility sends another shipment to the United States. | A shipment-specific filing, such as food Prior Notice, creates a separate charge when ordered. |
What triggers an additional fee
The clean dividing line is standing coverage versus transaction work. Standing coverage keeps the U.S. Agent relationship active. Transaction work begins when the team must prepare, review, correct, or submit a facility record, product record, label, shipment filing, or structured regulatory dataset.
| Additional work | Current published price | What causes the charge |
|---|---|---|
| Food facility registration or renewal filing | $249 | An initial registration, biennial renewal, or separately scoped registration transaction must be prepared and submitted. |
| Cosmetic facility registration | $449 | A foreign or domestic cosmetic facility needs an initial registration or biennial renewal submission. |
| Drug establishment registration | $449 per year | The establishment needs its annual registration prepared or maintained separately from the agent relationship. |
| Medical-device establishment registration | $349 per year, plus the applicable FDA fee | The establishment registration must be submitted or renewed through the FDA device system. |
| Food Prior Notice | $30 per filing | A food shipment requires a separate Prior Notice submission before arrival. |
| Cosmetic product listing | $299 per product | A marketed cosmetic product must be listed, updated, or renewed. |
| Drug product listing | $299 per product, with SPL included | A drug product needs an NDC listing or a product-level update. |
| Medical-device listing | $50 per device | A device must be added to or maintained in the establishment’s listing record. |
| Standalone SPL submission | $249 per submission | A drug or device submission requires separate Structured Product Labeling work. |
| Food label review | $349 for basic formatting or $600 for standard review | A new label, changed formulation, revised claim, or packaging update needs review. |
| Cosmetic, drug, or device label review | $449 per product or change | A product enters the market or its formula, claims, directions, warnings, or label content changes. |
| Standalone DUNS application | $95 | A DUNS application is ordered without a facility-registration engagement. |
| FSVP, GUDID/UDI, or Responsible Person work | Separately scoped | The client needs FDA responsibilities or technical submissions beyond the U.S. Agent role. |
Three boundaries that prevent surprise invoices
Renewal tracking is not the renewal filing
Tracking means maintaining the relevant calendar and alerting the client before action is due. Filing means collecting current facility data, reviewing the record, preparing the submission, resolving system issues, submitting it, and returning confirmation. The annual agent fee covers the first function; the separately listed registration charge covers the second.
Explaining a notice is not an unlimited response engagement
Receipt, escalation, deadline identification, and initial explanation sit inside active agent coverage. A notice that requires technical evidence, a revised registration, an SPL correction, a detention response, a warning-letter response, or formal legal analysis creates new work. The client should receive that scope and price before the additional work begins.
Shipment volume does not change the agent fee, but filings can
A seasonal food exporter does not pay another U.S. Agent charge for each container. Prior Notice is a different obligation tied to the shipment, so FDA Entry Point prices it at $30 per filing. FSVP responsibility is also separate because the FSVP importer must accept supplier-verification duties in writing; naming a registration U.S. Agent does not transfer those duties. See the FSVP Importer and U.S. Agent distinction.
Renewal, cancellation, and payment terms
- Service term: Annual U.S. Agent services are billed as a 12-month subscription.
- Automatic renewal: The subscription renews automatically to maintain continuing representation.
- Cancellation notice: Cancellation requires 30 days’ notice.
- Payment timing: Payment is due in full before work begins.
- Agent renewal versus FDA renewal: Paying the annual agent fee continues the private service relationship. It does not itself submit a food, cosmetic, drug, or device registration renewal.
The annual fee is a private professional-service charge, not an FDA charge for naming an agent. FDA does not charge for food facility registration or renewal, although a private provider can charge for preparing and managing that work. FDA guidance on private U.S. Agent fees makes that distinction explicit.
Medical-device establishments have a separate government cost. The FDA annual establishment registration fee is $13,785 for fiscal year 2027, which runs from October 1, 2026 through September 30, 2027. That government fee is not part of FDA Entry Point’s $395 agent fee or its $349 registration-service charge. FDA medical-device user fees publishes the current amount.
A worked food-exporter budget
A foreign food facility purchasing one year of U.S. Agent coverage, one food facility registration filing, and two Prior Notice filings would start at $604: $295 for annual agent coverage, $249 for registration, and $60 for the two shipment filings. Label review, FSVP work, additional Prior Notices, amendments, and urgent corrective work would be added only when ordered.
This example shows why the annual fee should not be compared with an all-inclusive market-entry package. The $295 keeps the agent relationship active; facility, product, and shipment events determine the rest of the budget.
FDA Entry Point is the best fit when
- A founder or operations lead has no dedicated U.S. regulatory employee and needs FDA messages explained, not merely forwarded.
- A foreign manufacturer wants recurring agent coverage separated clearly from registration, product, label, and shipment charges.
- A stretched compliance team wants one relationship that can handle additional food, cosmetics, drug, or medical-device work when a requirement moves beyond the agent role.
- The company is switching after a missed renewal, buried notice, or unresponsive mailbox-only service and wants an accountable communication process.
The practical advantage is continuity. The annual fee covers the U.S. contact relationship, while separately priced specialists remain available for the filings that arise around it. The FDA Entry Point compliance process explains how designation, communication handling, filings, and renewals connect.
Frequently asked questions
How much does FDA Entry Point charge for U.S. Agent services?
FDA Entry Point charges $295 per year for foreign food and cosmetic facilities and $395 per year for foreign drug and medical-device establishments, as of October 27, 2026. Registration, product listing, label review, Prior Notice, SPL, GUDID/UDI, FSVP, and other filing work are not automatically included. Current figures appear on the FDA Entry Point pricing schedule.
Does the $295 fee include FDA facility registration?
No. The $295 fee covers annual U.S. Agent service for food or cosmetics, while the filing is a separate transaction. Food facility registration is currently $249, and cosmetic facility registration is $449. This separation lets a company with a current registration purchase agent coverage without paying again for filing work it does not need.
Will FDA Entry Point charge for every shipment?
No additional agent fee is triggered merely because another shipment enters the United States. Food Prior Notice is separate and currently costs $30 per filing because it requires shipment-specific data and an electronic submission. Customs brokerage, FSVP work, detention responses, and import-alert matters are also distinct from standing U.S. Agent coverage.
Is a cheap FDA U.S. Agent worth the risk?
A lower-cost service can be sufficient when an experienced regulatory team already owns every registration, listing, renewal, shipment filing, and FDA response. It is a poor operating fit when a founder or stretched compliance lead expects the agent to explain notices and coordinate action. The useful comparison is the total scope assigned to the provider, not the annual name-on-file price.
Why do some FDA U.S. Agent providers require a quote?
A quote is appropriate when the work varies by facility count, product portfolio, submission system, shipment frequency, or active compliance problem. The important distinction is whether the quote itemizes the annual agent fee, renewal price, facility filings, product charges, shipment charges, cancellation terms, and response work. An unitemized total makes it impossible to compare the real recurring cost.
What happens when FDA sends a notice to FDA Entry Point?
FDA Entry Point receives the notice, escalates it to the client, explains the issue and stated deadline, and coordinates the immediate next step. Routine handling remains part of the annual relationship. If the matter requires a corrective filing, formal response package, product remediation, laboratory evidence, detention defense, or legal work, that additional project is scoped separately.