FDA Registration & Compliance Services
One partner for FDA registration and compliance across food, drugs, medical devices and cosmetics. We confirm what FDA requires for your product first, then handle the registrations, listings, U.S. Agent service, label reviews, import filings and renewals that apply. Independent FDA regulatory consulting since 2013, serving 1,000+ companies across 135+ countries.
Not sure what applies? Tell us what you make, import or plan to sell in the U.S. We'll map the requirements and send a clear scope and quote.
Get a Free ConsultationFDA Services by Industry
Food & Beverage
- Food facility registration and biennial renewal
- U.S. Agent and FSVP support
- Prior Notice for shipments
- Label and ingredient review
Drugs & Pharma
- Drug establishment registration
- Labeler Code and NDC listing
- Drug U.S. Agent
- Labeling and Drug Master File support
Cosmetics & MoCRA
- MoCRA facility registration
- Cosmetic product listing
- Cosmetic U.S. Agent
- Label and ingredient review
Medical Devices
- Establishment registration and device listing
- Device U.S. Agent
- QMSR and labeling support
- Laser accession reporting
End-to-End Registration and Compliance Support
Correct Regulatory Scope
Which FDA category, facility obligations, listings, importer duties and submissions apply, before work begins.
Registration & Listing
Facility registrations, product or device listings, amendments and supporting records.
U.S. Representation
U.S. Agent service where the FDA program requires a U.S. contact for foreign facilities.
Label & Compliance Review
Labels, ingredients, claims, warnings and documents checked against the rules for your category.
Renewals & Maintenance
Annual or biennial renewals, updates, U.S. Agent coverage and listing maintenance.
Import & Enforcement
FSVP, Prior Notice, detention response, Import Alert matters and corrective actions.
Additional FDA Compliance and Submission Support
U.S. Agent Services
U.S. Agent for foreign food, drug, device and cosmetic facilities.
FSVP Agent Services
Supplier evaluation, records and verification for imported food.
FDA Prior Notice
Prior Notice filed before food shipments arrive.
Food Label & Ingredient Review
Nutrition Facts, ingredients, allergens, net quantity and claims.
Dietary Supplement Compliance
Facility registration, cGMP, Supplement Facts, claims and NDIs.
Import & Shipment Compliance
Registration monitoring and support for U.S.-bound shipments.
Renewal Management
Deadline tracking and filing for registrations and listings.
FDA Import Alert Removal
Corrective-action plans and removal requests for DWPE.
Laser Accession Report
Laser product reports and accession-number follow-up.
Our Fees and FDA's Fees Are Separate
| Program | FDA Government Fee | Notes |
|---|---|---|
| Food facility registration | None | Our service: $858 per year with U.S. Agent (FDA food facility registration Q&A) |
| Cosmetic facility registration (MoCRA) | None | Facility registration and product listing |
| Medical device establishment | $13,785 per year, FY 2027 | No small business discount (FY 2027 device user fee notice) |
| OTC monograph drug facility | Annual OMUFA facility fee | FDA OMUFA program |
Every quote lists our professional fee and any government fee separately. See the registration pricing list.
A Long-Term FDA Compliance Partner
- Clear service scope before any filing or submission work begins
- Category-specific support instead of one-size-fits-all registration advice
- Direct phone and email access to our U.S.-based compliance team
- Support for both foreign and domestic regulated businesses
- Renewal, amendment, listing, U.S. Agent and ongoing maintenance support
- Professional fees and government fees identified separately
Not Sure Which FDA Services Apply?
Tell us what you manufacture, import, distribute or plan to sell in the United States. We review the product category and business structure, identify the compliance path that fits and send a clear scope and quote.
- Food, drug, device and cosmetic programs.
- Foreign and domestic companies.
- Agree the scope, documents and pricing before any paid work begins.
Contact our specialists, email info@fdaregistrationassistance.com, or call +1 (928) 275-8333. Registration pricing · FDA U.S. Agents.
Get a Free ConsultationFDA Registration Assistance is a private consulting firm, not FDA or any government agency. FDA registration is not FDA approval, clearance or certification.
Frequently Asked Questions — FDA Compliance Services
What FDA compliance services do you provide?
FDA Registration Assistance supports food, drug, medical-device, cosmetic, dietary-supplement, and import-compliance matters. Services include facility registration, product or device listing, U.S. Agent representation, FSVP, Prior Notice, label review, renewals, import-alert assistance, and specialized submissions such as laser radiation product reports.
Does FDA registration mean my product is FDA approved?
No. Registration or listing generally does not mean FDA has approved, cleared, certified, or endorsed a product or company. Some products have separate premarket authorization requirements, and the correct pathway depends on the product category and intended use.
Which foreign companies need a U.S. Agent?
U.S. Agent requirements depend on the FDA-regulated category and the foreign establishment's activity. Foreign food, drug, medical-device, and covered cosmetic facilities can have U.S. Agent requirements under their respective registration frameworks. We review the actual category before confirming the role.
Is FSVP the same as food facility registration?
No. Food facility registration applies to covered facilities, while the Foreign Supplier Verification Program is an importer-side food-safety requirement for many imported foods. A foreign facility can need a U.S. Agent while the U.S. importer separately has FSVP responsibilities.
Can you review labels for more than one FDA category?
Yes. We provide category-specific labeling support for foods, dietary supplements, drugs, medical devices, and cosmetics. The regulations and review scope differ by category, so each label is assessed against the requirements that apply to that product.
Do medical laser products need an FDA Laser Product Report?
Some laser products are subject to FDA Electronic Product Radiation Control reporting and performance-standard requirements. Whether a report is required depends on the product, classification, configuration, and applicable exemptions. Our Laser Accession Report service reviews that scope and prepares the report when required.
Can one FDA registration cover food, drugs, cosmetics, and medical devices?
No. FDA programs are category-specific. A company selling products in multiple regulated categories may need separate facility registrations, product or device listings, U.S. Agent designations, labeling reviews, and other compliance work.
How long does FDA registration take?
Turnaround depends on the service and the completeness of the information provided. Many basic registration or listing services can move quickly once all required information is complete; for example, a food facility registration can often be submitted the same day once the facility details and DUNS Number are ready. Technical submissions, reviews, corrective-action matters, and agency-dependent processes can take longer.
Do you manage renewals and ongoing compliance?
Yes. We support recurring registration and listing maintenance, U.S. Agent service, amendments, renewal filings, product updates, and other continuing requirements. The renewal cycle differs by FDA program, so we track each service on its actual schedule.
How do I know which services I need?
Send us your company location, product category, manufacturing location, intended U.S. activity, and whether you are importing or selling directly. We will map the regulatory pathway and provide a clear service scope before work begins.
Does FDA charge a fee to register?
It depends on the program. FDA charges no fee to register a food facility (FDA food facility registration Q&A) or a cosmetic facility. Medical device establishments pay an annual registration fee of $13,785 for FY 2027 (FY 2027 device user fee notice), and OTC monograph drug facilities pay an annual OMUFA facility fee (FDA OMUFA program). Our service fees are separate and quoted before work begins.
Do you offer "FDA approval" services?
We do not sell FDA approval, and no consultant can. Registration and listing are not approval. Where a product needs premarket authorization, such as a device 510(k) or a new drug, we help identify the pathway and prepare the work, but the decision is FDA's. We also help with the compliance steps most products need instead: registration, listing, labeling and import requirements.
Do you work with foreign companies?
Yes. Most of our clients are outside the U.S. We register foreign facilities, serve as the required U.S. Agent, review U.S. labeling and support FSVP, Prior Notice and import issues, for 1,000+ companies across 135+ countries.
What does food facility registration with U.S. Agent cost?
Our food facility registration service is $858 per year and includes the registration, U.S. Agent service for foreign facilities and biennial renewal management. FDA charges no fee for food facility registration. See the registration pricing list for other services.
Request a Free Consultation
Tell us what your company makes, sells, or distributes, where each product is manufactured or packed, your U.S. importer or buyer arrangement, label readiness, and target shipment date.
Submitting this inquiry does not purchase a service or authorize paid work. Our team can discuss the scope and required materials before you commission assistance. Fields marked with an asterisk are required.