Foreign Food Facility Registration
Per Year$858/ year
Includes professional filing + U.S. Agent
2026-2027 Pricing List
FDA Registration Fees & Pricing
Transparent professional pricing for FDA food, drug, medical device, cosmetics, U.S. Agent, labeling, listing, import, renewal, and specialized compliance services.
Direct answer: Most prices on this page are professional service fees paid to FDA Registration Assistance, not FDA government fees. FDA charges no fee to register a food facility. Medical device establishment registration is different: FDA charges a separate annual government user fee in addition to our professional service.
2026-2027 Pricing Overview
Clear Pricing Across FDA-Regulated Industries
Use this page to compare our professional service fees across food, drugs, medical devices, and cosmetics. Government fees, where applicable, are shown separately so you can see the real cost structure.
- Food & Beverage
- Drugs & Pharmaceuticals
- Medical Devices
- Cosmetics & MoCRA
Food & Beverage
Food & Beverage Pricing
Professional service fees for food facility registration, U.S. Agent representation, labeling, FSVP, Prior Notice, food safety plans, and import compliance.
Explore Food ServicesDomestic Food Facility Registration
Per Year$858/ year
Professional registration filing service
DUNS Request Assistance
One-Time$399
One-time professional service
Food U.S. Agent — Standalone
Per Year$858/ year
For foreign food facilities; FDA charges $0
Ingredients & Label Review
Per Service$249
Per label / review
HACCP Plan Development
Per Service$1,500
First product · $800 each additional
Prior Notice Filing
Per Service$35
Per filing
Foreign Supplier Verification Program (FSVP)
Custom QuoteCustom Quote
Scope depends on products, suppliers, and importer structure
FSVP Agent Services
Custom QuoteCustom Quote
Importer/agent scope reviewed before quoting
Food Safety Plan / Preventive Controls
Custom QuoteCustom Quote
Facility- and product-specific
FDA Detention / Import Alert Support
Custom QuoteCustom Quote
Case-specific review and response
FCE / SID Submission
Per Service$1,250
Starting professional fee for first SKU
Amazon / Marketplace FSVP Support
Custom QuoteCustom Quote
Based on importer and product scope
Drugs & Pharmaceuticals
Drug Registration & Listing Pricing
Professional fees for drug establishment registration, Labeler Code, NDC/product listing, U.S. Agent, labeling, DMFs, verification, and import-alert matters.
Explore Drug ServicesDrug Establishment Registration
Per Year$849/ year
Professional establishment registration service
Labeler Code Request
One-Time$349
One-time professional service
NDC / Drug Product Listing
Per Service$199
Per code / product
Drug Labeling & Ingredient Review
Per Service$249
Per review
Drug DUNS Request Assistance
One-Time$399
One-time professional service
Drug U.S. Agent Services
Per Year$849/ year
Annual professional representation
Drug Listing Verification Document
Custom QuoteCustom Quote
Private verification; not FDA-issued
Drug Master File (DMF) Services
Custom QuoteCustom Quote
Depends on DMF type and submission scope
Drug Import Alert Removal
Custom QuoteCustom Quote
Case-specific regulatory support
Medical Device Pricing
Professional service fees are separate from FDA government user fees. Most establishments required to register must also pay FDA's annual establishment registration fee.
Explore Medical Device ServicesFDA government medical-device establishment fee — separate from our professional serviceFY 2026: $11,423 through Sept. 30, 2026 • FY 2027: $13,785 from Oct. 1, 2026 through Sept. 30, 2027.
Medical Device Establishment Registration
Per Year$849/ year
Professional service · FDA government fee separate
Medical Device Listing
Per Service$249
Per device
Medical Device DUNS Assistance
One-Time$399
One-time professional service
Medical Device Label & Product Review
Per Service$249
Per product review
Medical Device U.S. Agent Services
Per Year$849/ year
Annual professional representation
Registration & Listing Verification
Custom QuoteCustom Quote
Private verification; not FDA-issued
QMSR / cGMP Support
Custom QuoteCustom Quote
Scope depends on quality-system needs
Annual Establishment Renewal Service
Per Year$849/ year
Professional renewal service · FDA fee separate
Import Alert & Device Detention Resolution
Custom QuoteCustom Quote
Case-specific regulatory support
Laser Accession Report & Submission
Per Service$3,500
Per standard Laser Product Report submission
Cosmetics & MoCRA
Cosmetics & MoCRA Pricing
Professional service fees for cosmetic facility registration, product listing, labeling, business identifiers, California reporting, verification, and ongoing MoCRA maintenance.
Explore Cosmetics ServicesMoCRA Facility Registration + U.S. Agent
Per Year$849/ year
Annual professional service; facility renewal itself is biennial
MoCRA Cosmetic Product Listing
Per Service$200
Per product
Cosmetic Labeling & Ingredient Review
Per Service$249
Per review
Cosmetics DUNS Request Assistance
One-Time$399
One-time service; DUNS is optional on Form FDA 5066
California Safe Cosmetics Reporting
Custom QuoteCustom Quote
California reporting scope reviewed before quoting
MoCRA Listing Verification
Custom QuoteCustom Quote
Private verification; not FDA-issued
MoCRA Registration & Listing Maintenance
Per Year$849/ year
Annual professional maintenance service
Legal Framework
The FDA Programs Behind These Services
Food, drugs, medical devices, and cosmetics follow different registration and maintenance rules. This page keeps those programs separate instead of applying one set of rules to every category.
FD&C Act §415 / 21 CFR Part 1
Covered food facilities register with FDA and renew in each even-numbered year between October 1 and December 31.
FD&C Act §510 / 21 CFR Part 207
Drug establishments register and list applicable drug products under FDA's drug registration and listing framework.
FD&C Act §510 / 21 CFR Part 807
Applicable device establishments register and list devices; FDA also assesses an annual establishment registration user fee.
FD&C Act §607
Covered cosmetic facilities renew every two years from initial registration, while responsible persons update product listings annually.
Compliance Work
What a Professional FDA Compliance Service Should Do
A strong regulatory service starts with the correct scope, uses the right identifiers and FDA system, and follows the maintenance schedule that actually applies.
01
Scope the Correct FDA Program
Identify the correct category, establishment role, facility requirement, product listing requirement, U.S. Agent obligation, and importer-side responsibilities.
02
Validate Required Identifiers
Confirm the identifiers that actually apply, such as food-facility UFI/DUNS, FEI, DUNS for certain device workflows, or drug labeler information.
03
Prepare Registration or Listing Data
Organize the facility, ownership, product, category, contact, and representation information required for the applicable FDA system.
04
Coordinate U.S. Agent Requirements
Provide or update U.S. Agent representation when required by the applicable FDA program for a foreign establishment.
05
Track the Correct Renewal Cycle
Food, drugs, devices, and cosmetics do not all renew on the same schedule. Each account should follow its program-specific maintenance timeline.
06
Review Labels & Product Information
Evaluate labels, claims, ingredient statements, warnings, and product information against the regulatory framework that applies to the product.
07
Maintain Submission Records
Retain confirmations, reference numbers, submission records, and professional work products needed for ongoing compliance and client documentation.
08
Support Updates & Enforcement Matters
Assist with amendments, renewals, detained shipments, Import Alerts, corrective actions, and other follow-up work when included in scope.
Role Clarification
U.S. Agent vs. Owner / Operator
These are separate concepts, and the exact U.S. Agent duties differ across FDA-regulated categories.
| Attribute | U.S. Agent | Owner / Operator |
|---|---|---|
| Primary purpose | Communications link between FDA and applicable foreign establishment | Legal entity that owns or operates the establishment |
| Where located | In the United States when required by the program | Can be domestic or foreign depending on establishment |
| Who designates | The foreign establishment / registrant | The business itself |
| Same role across FDA programs? | No — duties and verification differ by food, drugs, devices, and cosmetics | No — establishment responsibilities also vary by category |
Glossary
FDA Registration & Pricing Terms
Plain-language definitions for common identifiers, systems, and compliance terms that appear across our service pages.
FURLS
FDA Unified Registration and Listing System, an umbrella platform used for several FDA registration and listing programs.
FFRM
Food Facility Registration Module used for FDA food facility registration and biennial renewal.
FEI
FDA Establishment Identifier, a facility identifier used across several FDA programs.
DUNS
Nine-digit identifier issued by Dun & Bradstreet. FDA recognizes DUNS as an acceptable UFI for food facility registration; its role differs by program.
U.S. Agent
U.S.-based contact required for certain foreign establishments under category-specific FDA rules.
NDC
National Drug Code used in drug listing; an NDC does not by itself mean FDA approval.
Labeler Code
FDA-assigned component of the NDC that identifies the labeler.
FSVP
Foreign Supplier Verification Program for many U.S. importers of food.
Prior Notice
Advance notice to FDA for imported food shipments before arrival.
MoCRA
Modernization of Cosmetics Regulation Act of 2022.
QMSR
FDA's Quality Management System Regulation for medical devices, effective February 2, 2026.
Accession Number
CDRH document-control identifier assigned to a received radiation safety report; not FDA approval.
Common Problems
Mistakes That Create Registration & Import Problems
Many issues come from using the wrong FDA program, renewal calendar, identifier, or product classification—not simply from missing a form.
Wrong Renewal Calendar
Applying one renewal schedule to every FDA program can create missed deadlines or inaccurate compliance advice.
Confusing Registration With Approval
Registration, listing, NDC assignment, or an accession number should not be marketed as FDA approval or certification.
Wrong Identifier
Using DUNS, FEI, UFI, registration number, or listing number interchangeably can cause bad filings and misleading records.
Unresponsive U.S. Agent
A foreign establishment can face registration or communication problems when its designated U.S. Agent cannot fulfill required duties.
Incomplete Facility Information
Mismatched legal names, addresses, ownership information, or facility identifiers can delay or prevent registration processing.
Missing Product Updates
Drug listings, device listings, cosmetic product listings, and other records require program-specific maintenance when information changes.
Label Claims Outside the Product Category
Drug-like, disease, performance, or approval claims can change classification or create labeling violations.
Import Compliance Gaps
Registration alone does not satisfy separate importer-side requirements such as FSVP, Prior Notice, entry documentation, or admissibility.
FAQs
2026-2027 FDA Pricing & Registration FAQs
Direct answers about professional service fees, FDA government fees, renewal cycles, MoCRA, drug registration, device fees, and laser reporting.
+Are these FDA government fees or professional service fees?
Unless a card specifically says otherwise, the prices shown are professional service fees paid to FDA Registration Assistance. FDA itself charges no fee for food facility registration. Medical device establishment registration is different because FDA charges a separate annual MDUFA establishment registration user fee.
+How much does food facility registration cost in 2026-2027?
Our professional service fee is $858 per year for foreign food facility registration with U.S. Agent service and $858 per year for domestic food facility registration. FDA itself charges $0 to register a food facility.
+Does FDA charge a government fee for food facility registration?
No. FDA states that there is no fee required to register a food facility. Third-party registration and U.S. Agent providers may charge professional service fees.
+What is the FDA medical device establishment registration fee for FY 2026?
FDA's FY 2026 annual medical device establishment registration fee is $11,423 for October 1, 2025 through September 30, 2026. Our professional service fee is separate.
+What is the FDA medical device establishment registration fee for FY 2027?
FDA's FY 2027 annual medical device establishment registration fee is $13,785 for October 1, 2026 through September 30, 2027. Our professional service fee is separate.
+How much is the Laser Accession Report & Submission service?
The professional fee is $3,500 for one standard Laser Product Report / Radiation Safety Product Report preparation and submission package. Additional testing, variance work, extensive redesign, or separate medical-device submissions are outside the standard scope unless included.
+How much does drug establishment registration cost?
Our professional Drug Establishment Registration service is $849 per year. Other FDA user fees may apply to specific drug programs or applications, but those are separate from this professional service.
+How much is a Drug U.S. Agent?
Our Drug U.S. Agent service is $849 per year for applicable foreign drug establishments.
+How much does an NDC / drug product listing cost?
Our professional NDC / drug product listing service is $199 per code or product. Possession of an NDC does not mean FDA approved the drug.
+How much does MoCRA cosmetic facility registration cost?
Our MoCRA facility registration and annual U.S. Agent service is $849 per year when U.S. Agent representation is required. Registration does not mean FDA approval.
+How often does a cosmetic facility renew its MoCRA registration?
Covered cosmetic facilities renew their FDA registration every two years from the date of initial registration. This is not a universal October-to-December even-year window.
+How often are cosmetic product listings updated?
The responsible person must provide updates to covered cosmetic product listings annually. Our professional product listing service is $200 per product.
+Is DUNS required for MoCRA cosmetic facility registration?
No. FDA's current Form FDA 5066 requires the facility FEI and lists the facility DUNS Number as optional. Our $399 DUNS service is available for companies that need a DUNS for business or other regulatory workflows.
+Does FDA registration mean my product is FDA approved?
No. Facility registration, product listing, device listing, an NDC, or a radiation-report accession number generally does not mean FDA approved, cleared, certified, or endorsed the product. Separate premarket requirements may apply depending on the category.
+How often do food facilities renew FDA registration?
Covered food facilities renew every two years during the October 1 through December 31 period of each even-numbered year.
+How often do drug establishments renew FDA registration?
Drug establishments renew registration annually between October 1 and December 31.
+How often do medical device establishments renew FDA registration?
Medical device establishments that are required to register renew annually. The annual FDA establishment registration user fee is separate from our professional renewal service.
+Why are some services listed as Custom Quote?
Custom-quote services vary by product count, supplier count, technical complexity, agency history, corrective-action needs, or submission scope. We review the case before setting a professional fee.
+How do I confirm which services I need?
Send us your company location, product category, manufacturing location, intended U.S. activity, and import structure. We will map the regulatory pathway and confirm the applicable professional fees before work begins.
+Are prices shown in U.S. dollars?
Yes. All prices on this page are shown in U.S. dollars unless a specific service states otherwise.
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