FDA Compliance Services & FDA User Fees
Professional U.S. FDA compliance assistance for domestic and foreign manufacturers, exporters, importers and distributors of FDA-regulated products entering or operating in the United States market.
U.S. FDA Consultants assist companies throughout Asia, Africa, Latin America and Europe with facility and establishment registration, product listing, U.S. Agent services, FSVP, labeling, Prior Notice and other regulatory compliance requirements.
Service Fees and FDA User Fees Are Not the Same
Depending on the product and regulatory activity, a company may encounter professional service fees, government user fees, or both. Understanding the difference helps manufacturers and exporters properly budget before entering the U.S. market.
FDA Consultant Service Fees
Service fees compensate U.S. FDA Consultants for regulatory assistance such as registrations, renewals, listings, U.S. Agent representation, FSVP assistance, Prior Notice filings, label reviews and other compliance work.
The applicable service fee depends on the regulated product, establishment, number of products, scope of work and regulatory services requested.
FDA User Fees
FDA user fees are government fees established under specific statutory user-fee programs. They are separate from consulting or registration-assistance service fees.
Not every FDA-regulated establishment or product is subject to the same user fee. The applicable amount depends on the regulatory program and fiscal year.
FDA Compliance Services
Services can be coordinated for both U.S. companies and foreign businesses preparing to manufacture, export, import, distribute or market FDA-regulated products in the United States.
Food Facility Registration
Assistance with U.S. and foreign food facility registration, biennial renewal, facility information and U.S. Agent requirements for foreign food facilities.
Food Facility ServicesSupplement Compliance
Regulatory assistance for dietary supplement establishments and products, including facility registration support and Supplement Facts or labeling review.
Supplement ServicesFSVP Importer Service
Foreign Supplier Verification Program assistance for companies supplying imported food to the United States, including Amazon U.S. fulfillment channels.
FSVP ServicesFDA Prior Notice
Assistance preparing and submitting Prior Notice for food shipments offered for import into the United States through commercial carriers and other shipping channels.
Prior Notice ServiceFDA Label Review
Review of product labeling for applicable FDA requirements, including Nutrition Facts, Supplement Facts, Drug Facts, ingredient declarations, claims and other required labeling elements.
Label ReviewFCE & Process Filing
Assistance for manufacturers of low-acid canned foods and acidified foods with Food Canning Establishment registration and related FDA compliance activities.
Canned Food ServicesDevice Registration & Listing
Assistance for domestic and foreign medical-device manufacturers with establishment registration, device listing, U.S. Agent coordination and related compliance.
Medical Device ServicesDrug Establishment Compliance
Regulatory assistance for prescription and over-the-counter drug establishments, including registration, product listing and U.S. Agent support where applicable.
Drug ServicesOTC & OMUFA Compliance
Assistance for OTC monograph drug manufacturers, including establishments producing sunscreen, antidandruff products, fluoride toothpaste, antiperspirants and other OTC monograph drugs.
OTC Drug ServicesMoCRA Compliance
Assistance with cosmetic facility registration, responsible-person product listing and other compliance activities associated with the Modernization of Cosmetics Regulation Act.
Cosmetic ComplianceU.S. Agent Service
U.S. Agent representation and communications support for qualifying foreign establishments subject to FDA registration requirements.
U.S. AgentFDA Hold & Detention Assistance
Regulatory assistance when products encounter an FDA hold, detention, admissibility issue or other import compliance problem requiring prompt review.
Detention AssistanceProducts We Help Companies Bring to the U.S. Market
FDA Compliance Support Across Major Export Markets
Foreign manufacturers need to consider FDA requirements before products are offered for import into the United States. Our services are designed for companies across the principal manufacturing and exporting regions of the world.
Asia
Manufacturers and exporters in China, India, Japan, South Korea, Taiwan, Vietnam, Thailand, Indonesia, Pakistan and other Asian markets.
Europe
Manufacturers and exporters throughout the European Union, United Kingdom, Switzerland, Turkey and other European markets.
Latin America
Companies in Mexico, Brazil, Colombia, Argentina, Chile, Peru, Central America, the Caribbean and other Latin American markets.
Africa
Manufacturers and exporters in North, West, East, Central and Southern Africa preparing FDA-regulated products for the United States.
Selected FDA User Fees — Fiscal Year 2026 Compared With Fiscal Year 2027
FDA has published Fiscal Year 2027 rates for the selected MDUFA and OMUFA fees below. FY 2027 begins October 1, 2026 and ends September 30, 2027. The comparison helps medical-device and OTC monograph drug establishments plan for changes in government user-fee obligations.
Annual Establishment Registration Fee
FY 2027 rate applies October 1, 2026 through September 30, 2027.
Verify MDUFA Fees on FDA.govMonograph Drug Facility — MDF
For FY 2027, FDA states the facility fee is payable in two 50% installments, subject to the statutory appropriations timing rules: first installment beginning October 1, 2026 and second installment beginning February 1, 2027.
Verify OMUFA Fees on FDA.govContract Manufacturing Organization — CMO
A qualifying CMO facility fee remains two-thirds of the applicable MDF fee under OMUFA.
Verify OMUFA Fees on FDA.govHow to Pay FDA User Fees
FDA user fees are paid directly to the U.S. Food and Drug Administration through the applicable FDA user-fee program. Before sending money, identify the correct program, fee type, fiscal year and establishment or submission. FDA's User Fee System is used to create applicable cover sheets or payment records and to associate the payment with the correct FDA obligation.
1. Identify the Correct User-Fee Program
Determine whether the payment relates to MDUFA, OMUFA, PDUFA, GDUFA or another FDA user-fee program. Do not assume that paying one FDA user fee satisfies an obligation under another program.
2. Create the Required Cover Sheet or Payment Record
Access the applicable FDA user-fee system or program page. Where a cover sheet is required, enter the requested establishment, application, facility or submission information. FDA generates identifying information that helps match the payment to the correct fee obligation.
3. Verify the Amount and Fiscal Year
Confirm the fee amount before payment. For annual fees, make sure the payment is for the correct fiscal year. For facility fees, verify that the facility is actually fee-liable and that identifiers such as the FEI are accurate where required.
4. Pay Through an FDA-Approved Electronic Method
FDA no longer accepts paper-based payments beginning October 1, 2025. FDA states that payments must be made electronically in U.S. currency. Online electronic check (ACH/eCheck) or credit card are preferred; wire transfer is also available.
5. Include the Correct Payment Reference
When the FDA system generates a user-fee identification number, invoice number or other payment reference, use it exactly as instructed. This is especially important for wire transfers so FDA can associate the incoming funds with the correct establishment, invoice or submission.
6. Keep Proof of Payment
Save the FDA cover sheet, payment confirmation, transaction receipt, invoice and any related correspondence. Retaining these records can help resolve payment-posting questions and demonstrate timely payment.
Electronic Payment Methods
FDA identifies online electronic check through the Automated Clearing House as a preferred payment method.
FDA's online payment system accepts supported credit cards. Follow the instructions displayed in the FDA payment portal.
Wire transfer is available. Obtain and follow the current FDA wire instructions and include the required payment reference. Your bank may charge a separate wire fee.
FDA Wire Transfer Instructions
Provide the following information to your bank or financial institution when remitting an applicable FDA user fee by wire transfer.
Which FDA-Regulated Businesses May Encounter User Fees?
Medical Device Establishments
Many medical-device establishments required to register with FDA are subject to the annual establishment registration fee. Separate user fees may also apply to certain device submissions.
OTC Monograph Drug Facilities
Qualifying OTC monograph drug manufacturing facilities can be subject to OMUFA facility fees. The applicable amount differs between an MDF and qualifying CMO.
Prescription & Generic Drugs
Drug manufacturers may encounter separate FDA user-fee programs depending on the type of application, facility and regulated drug activity.
Other FDA User-Fee Programs
FDA administers multiple congressionally authorized user-fee programs. Companies should identify the specific program applicable to their establishment, submission or product before arranging payment.
Why Work With U.S. FDA Consultants?
Coordinate Multiple Requirements
- Facility or establishment registration
- Product listing
- U.S. Agent representation
- FSVP importer support
- Prior Notice
- Label review
- FDA detention assistance
Understand the Complete Cost
A regulatory project may involve consultant service fees, FDA user fees, testing, labeling corrections, customs-related costs or additional compliance work. Identifying these items before shipping can help reduce unexpected delays and expenses.
A Practical FDA Compliance Process
Identify the Product
Determine whether the product is food, supplement, cosmetic, OTC drug, prescription drug, medical device or another FDA-regulated category.
Review the Facility
Determine the registration, listing, U.S. Agent, FSVP or other requirements applicable to the manufacturing and exporting operation.
Identify Applicable Fees
Separate professional service fees from any applicable FDA government user fees before registration or submission.
Complete Compliance Work
Complete the required registrations, listings, filings, labeling activities and other steps before products are commercially distributed in the United States.
Preparing to Manufacture, Export or Sell FDA-Regulated Products in the United States?
U.S. FDA Consultants can help domestic and foreign manufacturers and exporters determine which FDA registration, product listing, U.S. Agent, FSVP, labeling, Prior Notice and other compliance requirements apply to their products.
We can also help you distinguish professional service fees from applicable FDA government user fees before your company begins the registration or compliance process.
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