Registration Fees & Pricing
FDA registration is the federal compliance act of notifying the U.S. Food and Drug Administration that a facility manufactures, processes, packs, holds, or imports an FDA-regulated product — food, dietary supplements, drugs, medical devices, or cosmetics — for U.S. commerce. The requirement is established by the Federal Food, Drug, and Cosmetic Act and operationalized through the regulations in Title 21 of the Code of Federal Regulations, including 21 CFR Part 1, Subpart H for food facilities, 21 CFR Part 207 for drug establishments, 21 CFR Part 807 for medical device establishments, and the Modernization of Cosmetics Regulation Act (MoCRA) for cosmetics. Registration assigns each facility a unique identifier in the FDA Unified Registration and Listing System (FURLS), giving FDA the inspection, recall, and import-control authority required by federal law. Without a valid registration, the FDA can refuse your shipments at the U.S. port of entry, cancel your facility record, issue Warning Letters, and trigger delisting from Amazon, Walmart, and Shopify — effectively cutting your product off from the U.S. market. FDA itself charges $0 for food, drug, and cosmetic facility registration — the prices on this page for those categories are professional service fees paid to FDA Registration Assistance for filing, U.S. Agent designation, renewal tracking, and ongoing regulatory support. Medical device registration is the exception: FDA collects a separate annual MDUFA Establishment Registration User Fee paid directly to FDA, in addition to the professional service fee listed.
Transparent, upfront pricing for every FDA registration and compliance service. All fees are listed in USD.
Foreign Food Facility Registration
Service fee · FDA charges $0 · includes U.S. Agent
Domestic Food Facility Registration
Service fee · FDA charges $0 · U.S.-based facilities
DUNS Request Assistance
One-time fee
U.S. Agent Fee
Service fee · FDA charges $0 · standalone (no registration)
Ingredients & Label Review
Per review
Hazard Analysis & Critical Points Plan (HACCP)
Prior Notice Filing
Per filing
Foreign Supplier Verification Program (FSVP)
FSVP Agent Fee
Food Safety Plans
FDA Detentions / Import Alert
Food Canning Establishment (FCE)
Foreign Supplier Verification Program for Amazon Sellers (FSVP)
Drug Establishment Registration
Labeler Code Registration
One-time fee
NDC Code / Product Code
Per code
Drug Labeling & Ingredient Review
Per review
DUNS Request Assistance
One-time fee
FDA Drug Listing Certificate
Drug Master Files (DMF)
Medical Device Establishment Registration
Service fee · excludes FDA MDUFA user fee (paid separately to FDA)
Medical Device Listing (Class I Products)
Service fee per device · FDA MDUFA fees paid separately
DUNS Registration Assistance
One-time fee
Medical Device Labeling & Product Review
Service fee per review
U.S. Agent Services
Service fee · FDA MDUFA user fee paid separately by establishment
MoCRA — Modernization of Cosmetics Regulation Act: Federal registration requirements now apply to all cosmetic manufacturers and importers selling in the United States. Registration and product listing are mandatory.
Establishment Registration
MoCRA required
Product Listing
Cosmetic Labeling & Ingredient Review
Per review
California Safe Cosmetics Act Reporting (CSCAR)
DUNS Request Assistance
One-time fee
File Registrations in the Correct FDA System
Submit Form FDA 3537 in FURLS for food facilities, eDRLS for drug establishments, FURLS-DRLM for medical devices, and Cosmetics Direct for MoCRA — each with the correct product codes, ownership structure, and registration type.
Verify and Issue a DUNS Number
Confirm the facility holds a valid 9-digit Dun & Bradstreet DUNS number tied to the actual physical address, as required by FDA in 21 CFR 1.232. Resolve mismatches between Dun & Bradstreet records and the registration before filing.
Act as the U.S. Agent for Foreign Facilities
Under 21 CFR 1.230, serve as the U.S.-based point of contact for FDA, accept service of process, respond to inspection notices, and remain reachable during U.S. business hours on behalf of the foreign facility.
Track Biennial and Annual Renewals
Manage food and cosmetic biennial renewals (Oct 1 – Dec 31 of even-numbered years) and annual drug/device renewals — and file before the deadline so the registration is never deemed expired under FD&C Act §801(l).
File Required Updates Within 60 Days
Under 21 CFR 1.234, file any change in facility ownership, address, U.S. Agent, contact information, or product category with FDA within 60 calendar days of the change. Missed updates void the registration.
Review Labels and Ingredients for Compliance
Audit product labels, ingredient declarations, allergen statements, and Nutrition/Drug/Supplement Facts panels against 21 CFR Part 101, Part 201, and Part 701 before shipment to prevent misbranding under FD&C Act §403 and §502.
Maintain Confidentiality of Facility Records
FDA registration data is protected from public disclosure under FD&C Act §415(a)(3). The registration agent must safeguard facility details, ownership information, and product categories from unauthorized disclosure.
Respond to FDA Inspections and Detentions
Coordinate FDA on-site inspections, respond to Form FDA 483 observations, manage import detentions under FD&C Act §801(a), and liaise with CBP and FDA Division of Import Operations on behalf of the facility.
| Attribute | U.S. Agent | Owner / Operator |
|---|---|---|
| Who Designates Them | Designated by the foreign facility on Form FDA 3537 | The legal entity that owns or runs the facility itself |
| Who They Represent | FDA's contact with the foreign facility — represents FDA's communications with the facility | Represents the business — has financial, regulatory, and operational responsibility for the facility |
| Required By | Only foreign facilities exporting to the U.S. | Every registered facility — domestic and foreign |
| Governing Regulation | 21 CFR 1.227 & 1.230 (food); 21 CFR 207.69 (drugs); 21 CFR 807.40 (devices) | 21 CFR 1.225 & 1.232 — defines the registering entity |
| Primary Function | Accept FDA communications, service of process, and inspection notices on behalf of the foreign facility | Operate the facility, maintain cGMPs, hold the registration, pay user fees, and bear legal liability |
| Required For | Foreign facilities only — must have a physical U.S. address and a real U.S. phone number | All FDA-registered facilities — listed on Form FDA 3537 as the registrant |
The U.S. Agent and the Owner / Operator are two distinct legal roles, and FDA expects them to be filled by two different parties. The Owner / Operator is the business that holds the registration and bears regulatory liability. The U.S. Agent is the U.S.-based communications link required by 21 CFR 1.230 for any foreign facility — someone reachable by FDA on a U.S. phone line who can accept inspection notices and service of process. A foreign business that exports to the U.S. typically needs both: someone designated as the Owner / Operator (their own corporate entity abroad), and a separate, qualified U.S. Agent inside the United States. Trying to combine the two roles, or using a friend with no regulatory expertise as the U.S. Agent, is the most common cause of FDA registration cancellation and import detention.
| Factor | DIY in FURLS | RecommendedFDA Registration Assistance |
|---|---|---|
| Cost | $0 government fee + your staff's time (typically 8–20 hours) | Starting at $858/yr (food + U.S. Agent bundle) — flat professional service fee; FDA charges $0 |
| Availability | You must monitor the FURLS account yourself, 24/7, in U.S. time zones | Monitored on your behalf — FDA emails reviewed same business day |
| Domain Support | FDA gives no regulatory advice — only technical FURLS help | Regulatory specialists familiar with 21 CFR, FSMA, MoCRA, and product-code classification |
| Risk of Failure | High — wrong product code, missed DUNS verification, or invalid U.S. Agent voids the registration | Low — every submission is pre-checked against FDA validation rules before filing |
| Confirmation Handling | You receive the FURLS confirmation email; misplaced or filtered messages cause renewal misses | Confirmation tracked, archived, and re-issued on request; renewal reminders sent 90 days out |
| Renewal Tracking | You must remember the biennial Oct 1–Dec 31 window every two years | Renewal filed automatically before deadline — no expired-registration risk |
Most businesses choose a professional service because the FDA gives no regulatory guidance — FURLS technical support cannot tell you the correct product code, whether your address qualifies, or whether your U.S. Agent is valid. A single missed renewal or invalid U.S. Agent can cancel the registration, freeze shipments at the port, and trigger Amazon or Walmart delisting. The flat fee is small compared to one detained container.
| Factor | Friend / Relative in the U.S. | RecommendedFDA Registration Assistance |
|---|---|---|
| Government Fee | $0 FDA government fee for U.S. Agent designation (no service fee — you handle it yourself) | $0 FDA government fee + $429/yr professional U.S. Agent service |
| Pros | Free; quick to set up; uses someone you already trust | Regulatory expertise; same-day FDA email handling; renewal & update tracking; inspection support |
| Cons | No regulatory training; may miss or filter FDA emails; cannot legally advise on responses; unavailable during inspections; high risk of registration cancellation | Annual fee — but no missed deadlines, no cancelled registrations, no detained shipments |
| Best For | Hobbyists or one-off shipments where loss of registration is acceptable | Any business actually selling product into the U.S. market — food, supplements, cosmetics, devices, or drugs |
FDA does not charge a fee for U.S. Agent designation, so legally a friend or relative can serve at $0 cost. The real risk is operational: untrained agents miss the FDA's inspection notices, fail to respond to import-detention emails within the 5-business-day window under FD&C Act §801(a), and cause the foreign facility's registration to be deemed invalid. A professional U.S. Agent reads, classifies, and responds to every FDA communication — the value is not the filing, it's everything that happens after.
The FDA Unified Registration and Listing System — the master online portal where food, drug, device, and cosmetic facilities file registrations, listings, and renewals.
The Food Facility Registration Module inside FURLS, used to submit Form FDA 3537 and obtain the 11-digit Food Facility Registration Number.
FDA Establishment Identifier — a unique numeric ID FDA assigns to every physical establishment in its database; used for inspections and import screening.
A 9-digit Dun & Bradstreet identifier required by FDA to verify the legal identity and physical address of a registering facility.
The U.S.-based individual or company designated under 21 CFR 1.230 as FDA's official communications link to a foreign facility.
National Drug Code — a 10- or 11-digit identifier assigned to each drug product (labeler + product + package), required by 21 CFR Part 207 for marketed drugs.
The first 4- or 5-digit segment of an NDC, assigned by FDA to identify the manufacturer, repackager, relabeler, or distributor of a drug product.
Advance electronic notification to FDA — required by 21 CFR 1.281 — for every shipment of imported food before it arrives at a U.S. port of entry.
Foreign Supplier Verification Program — the FSMA rule (21 CFR Part 1, Subpart L) requiring U.S. importers to verify that foreign suppliers meet U.S. food-safety standards.
Hazard Analysis and Critical Control Points — a science-based food-safety system required for seafood (21 CFR Part 123), juice (Part 120), and used as the foundation of Preventive Controls under Part 117.
The Modernization of Cosmetics Regulation Act of 2022 — the first federal law mandating cosmetic facility registration, product listing, and adverse event reporting.
A public FDA enforcement notice instructing field staff to detain — without physical examination — products from a specific facility, country, or supplier until compliance is proven.
Missed Biennial Renewal
Food and cosmetic registrations expire if not renewed between October 1 and December 31 of every even-numbered year. FDA deems the registration invalid and refuses imports under FD&C Act §801(l).
Invalid or Unresponsive U.S. Agent
If FDA cannot reach the designated U.S. Agent under 21 CFR 1.230, the foreign facility's registration is deemed invalid and every inbound shipment is held under detention.
P.O. Box or Virtual Address
21 CFR 1.232 requires a real physical street address where food is manufactured, processed, packed, or held. Virtual offices, mailbox stores, and P.O. boxes void the registration on audit.
DUNS Mismatch
If the Dun & Bradstreet record (entity name, address, primary trade style) doesn't match what is filed in FURLS, FDA's automated validation rejects the registration and freezes the application.
Wrong Product Category Code
Choosing the wrong food product category, device class, or cosmetic code on Form FDA 3537 misclassifies the facility, causes incorrect FSMA rule applicability, and can lead to Form FDA 483 observations on inspection.
Failure to Update Within 60 Days
Under 21 CFR 1.234, any change in address, ownership, U.S. Agent, or product category must be filed within 60 days. Late updates void the registration and break the chain of liability.
"FDA Approved" Label Claims
Claiming "FDA Approved" on a food, dietary supplement, Class I device, or cosmetic label is misbranding under FD&C Act §403/§502 — triggering Warning Letters, import refusal, and immediate Amazon listing suspension.
No Prior Notice Filed Before Shipment
Every imported food shipment must have a Prior Notice filed under 21 CFR 1.281 before arrival. Missed Prior Notice causes the shipment to be held at the port and triggers CBP examination delays.
How much does FDA food facility registration cost in 2026?
The U.S. FDA charges $0 for food facility registration. The price you see on this page — $858 USD per year for foreign or domestic facilities in 2026 — is a professional service fee paid to FDA Registration Assistance. The service fee covers filing in the FDA Unified Registration and Listing System (FURLS), DUNS verification, U.S. Agent designation, biennial renewal tracking, and ongoing FDA communications.
What is the cost of FDA drug establishment registration?
Drug establishment registration with the FDA costs $449 USD per year in 2026. The fee includes registration in FDA's Drug Registration and Listing System (DRLS) under 21 CFR Part 207, DUNS confirmation, and annual renewal management.
How much does medical device establishment registration cost?
Medical device registration has two separate costs. The $849 USD per year shown on this page is the professional service fee paid to FDA Registration Assistance for filing, U.S. Agent designation, and renewal tracking.
SEPARATELY, FDA charges its own annual MDUFA Establishment Registration User Fee, paid directly by the establishment to FDA — this FDA fee is NOT included in the $849 and is set annually under the Medical Device User Fee Amendments (21 CFR Part 807). Unlike food, drug, and cosmetic registration (where FDA charges $0), medical device establishments must pay both fees.
What is the MoCRA cosmetics establishment registration fee?
MoCRA cosmetics establishment registration costs $849 USD per year in 2026. The Modernization of Cosmetics Regulation Act made cosmetic facility registration mandatory; FDA charges no government fee, so the price is the professional service for filing, biennial renewal, and product listing coordination.
How much does HACCP plan development cost?
HACCP plan development costs $1,500 USD for the first product and $800 USD for each additional product. The plan is built to 21 CFR Part 117 (Preventive Controls for Human Food) or 21 CFR Part 123 (Seafood HACCP) requirements, including hazard analysis, critical control points, monitoring procedures, and corrective actions.
What is included in the $858 food facility registration service fee, and how does the U.S. Agent service work?
FDA charges $0 for food facility registration. The $858/year price is a professional service fee paid to FDA Registration Assistance, not a government fee.
The service fee covers: intake review, DUNS verification, filing in FURLS, the issued 11-digit registration number, U.S. Agent designation (a $429/year service on its own — bundled into the $858 for foreign facilities), biennial renewal during the Oct 1 – Dec 31 window of even-numbered years, and updates to ownership or address within the FDA-required 60-day window.
Can my U.S. Agent be a friend, relative, or unrelated party in the United States?
Yes — legally, any person or entity in the U.S. with a U.S. address and U.S. phone number can serve as a U.S. Agent under 21 CFR 1.227 and 21 CFR 1.230.
However, FDA expects the U.S. Agent to respond to communications quickly, accept service of process, assist with inspections, and remain reachable during U.S. business hours. A friend or relative typically does not have the regulatory knowledge or response infrastructure to fulfill these duties, and a single missed FDA communication can cause your registration to be cancelled or your shipments detained at the port.
What happens if my U.S. Agent doesn't respond to the FDA?
FDA may cancel your food facility registration, refuse your imports at the port, or escalate to a Warning Letter.
Under 21 CFR 1.230, the U.S. Agent is the official communications link between FDA and a foreign facility. If FDA cannot reach the U.S. Agent for routine inspections, prior-notice questions, or recall coordination, the facility's registration can be deemed invalid, and shipments are subject to detention under FD&C Act §801(a).
How do I change the U.S. Agent on an existing FDA registration?
Log into FDA FURLS, open the facility registration record, and submit an update designating the new U.S. Agent — FDA requires updates within 60 calendar days of any change under 21 CFR 1.234.
The new U.S. Agent must confirm acceptance through FDA's automated confirmation email; without that confirmation, the change is not recognized and the previous agent remains on record. We file the change in FURLS and confirm acceptance on the same business day.
Do I need FDA registration to sell food, supplements, or cosmetics on Amazon, Walmart, or Shopify in 2026?
Yes — Amazon, Walmart, and most major U.S. marketplaces require valid FDA registration documentation for food, dietary supplements, cosmetics, OTC drugs, and medical devices.
Sellers are typically asked to upload the FDA registration number, FURLS confirmation, or FDA Establishment Identifier (FEI). Listings without valid documentation are commonly delisted, and ASINs can be suppressed without warning.
Does FDA actually issue a certificate when I register a food facility?
No — FDA does not issue a paper certificate for food facility registration.
FDA issues an 11-digit Food Facility Registration Number and an electronic confirmation email through FURLS. Anyone selling you a "FDA Certificate" for food facility registration is misrepresenting it; the registration number itself, together with the FURLS confirmation, is the official proof of registration.
Is dietary supplement manufacturing covered under food facility registration or drug registration?
Dietary supplements are regulated as food under DSHEA (1994), so manufacturers register as food facilities under 21 CFR Part 1, Subpart H — not as drug establishments.
The same $858/year professional service fee for food facility registration applies (FDA charges $0), along with cGMP compliance under 21 CFR Part 111 (Current Good Manufacturing Practice for Dietary Supplements).
Do I need a separate FDA registration for each warehouse, co-packer, or 3PL location?
Yes — under 21 CFR 1.225, every physical location that manufactures, processes, packs, or holds food for U.S. consumption must register separately, including warehouses, co-packers, and third-party logistics (3PL) facilities.
Each location receives its own unique 11-digit registration number and must maintain a separate U.S. Agent if foreign. Consolidating multiple sites under one registration is a common cause of FDA Form 483 observations during inspection.
How long does FDA food facility registration take to complete?
Most registrations are filed and confirmed within 24 to 72 business hours once we have complete facility information, DUNS, and (for foreign facilities) U.S. Agent acceptance.
FDA's FURLS system issues the 11-digit registration number electronically, usually the same business day after submission.
Can I verify an FDA registration number publicly?
No — FDA does not maintain a public lookup tool for food facility registration numbers.
Registration data is confidential under FD&C Act §415(a)(3). To verify a registration, you must request the FURLS confirmation email or registration record directly from the facility, or have an authorized representative log into FURLS to retrieve it.
Does FDA registration mean my product is FDA approved?
No — FDA registration is not FDA approval.
Registration only confirms that the facility has notified FDA of its existence and product categories. Claiming "FDA Approved" on a food, supplement, cosmetic, or Class I device label is a misbranding violation under FD&C Act §403 and §502, and triggers Warning Letters, import refusal, and platform delisting.
My facility is at a residential or virtual address — can I still register it with the FDA?
Only if the address is the actual physical location where food is manufactured, processed, packed, or held.
Under 21 CFR 1.232, FDA requires a real physical street address — P.O. boxes, virtual mailboxes, and addresses that do not match the operational site are not accepted and can void the registration. Foreign facilities must list the actual foreign manufacturing address, not the U.S. Agent's address.
When do I have to renew my FDA food facility registration?
Every two years, between October 1 and December 31 of each even-numbered year, as required by FSMA (Food Safety Modernization Act, 2011) and codified in 21 CFR 1.230(c).
Missing the biennial renewal causes FDA to deem the registration expired, after which shipments can be refused entry under FD&C Act §801(l).
What's the difference between an FDA Registration Number, an FEI Number, and a DUNS Number?
They are three separate identifiers.
The FDA Registration Number is the 11-digit number issued by FURLS at the end of registration. The FEI (FDA Establishment Identifier) is a unique numeric ID FDA assigns to every physical establishment in its database, used for inspections. The DUNS Number is a 9-digit business identifier issued by Dun & Bradstreet, required by FDA to verify the facility's legal identity. All three are needed for a complete compliance file.
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