FDA Registration Assistance
Registration, U.S. Agent, classification, labeling, and import compliance — across food, drug, device, and cosmetic programs.
Key Takeaways
- Independent compliance firm — not the FDA or a government body.
- All four programs — food, drugs, devices, cosmetics.
- End-to-end — classification, registration & listing, U.S. Agent, labeling/claims, imports.
- Foreign-firm focused — U.S. Agent + market-entry support.
- Straight talk — registration ≠ approval; government fees kept separate; no guaranteed outcomes.
Our FDA Compliance Services
- Classification — is it food, a drug, a device, or a cosmetic? (including cosmetic-vs-OTC-drug and device class)
- Establishment registration & product listing — in the correct FDA systems, with renewals
- U.S. Agent — the required U.S.-based contact for foreign establishments
- Labeling & claims review — required panels, ingredient/allergen declarations, and lawful claims
- Premarket submissions — support where required (e.g., a device 510(k))
- Import compliance — FSVP, Prior Notice, initial importer, and import-alert response
Straightforward & Transparent
- We're independent — a private firm that helps you meet FDA's rules; FDA is the regulator, we're your service provider
- We keep fees separate — our service fee vs any FDA government fee (food/cosmetic registration is free; devices/OTC drugs have government fees)
- We describe status accurately — registered/listed, cleared, or approved only where it truly applies; not "FDA approved" where it isn't
- We don't promise FDA outcomes — no one can guarantee a clearance, approval, or import-alert removal; we make sure avoidable errors aren't the cause of a delay
Where to Start
What is the FDA?
The agency, its remit & approval vs registration.
Primer →FDA registration
Registration & listing, by program.
Registration →U.S. Agents
Required for foreign establishments.
U.S. Agent →Label review
Food, supplement, cosmetic & drug labels.
Labeling →Import alerts
DWPE, detentions & removal.
Imports →Cosmetic or drug?
The classification that drives everything.
Classify →Get FDA Compliance Assistance
Tell us what your product is, its intended use and claims, and whether you're domestic or foreign — and we'll confirm how FDA applies, identify exactly what's required, and give you a scoped quote. We handle registration and listing, U.S. Agent service, classification, labeling review, and import compliance — across food, drug, device, and cosmetic programs.
Contact us at info@fdaregistrationassistance.com or call +1 (928) 275-8333. An independent compliance firm serving 1,000+ companies across 135+ countries, with 15+ years of experience.
Frequently Asked Questions — FDA Registration Assistance
1. What is FDA Registration Assistance?
FDA Registration Assistance is an independent FDA compliance consulting firm that helps companies - domestic and foreign - meet FDA requirements across all four programs: food, drugs, medical devices, and cosmetics. We confirm your product's classification, complete FDA establishment registration and listing, serve as your U.S. Agent if you're a foreign firm, review labeling and claims, and support import compliance. We're a private consulting firm, not the FDA or a government body.
2. Are you the FDA or a government agency?
No. We're an independent, private compliance consulting firm - not the FDA, and not affiliated with the U.S. government. We help you understand and meet FDA's requirements, complete registrations in FDA's systems, and act as your U.S. Agent, but FDA is the regulator and we are your service provider. Any FDA government fees are paid to FDA, separately from our service fees, and we keep that distinction clear.
3. What services do you provide?
Across food, drug, device, and cosmetic programs: product classification (including the cosmetic-vs-OTC-drug and device-class questions); FDA establishment registration and product listing; U.S. Agent service for foreign establishments; labeling and claims review; premarket submission support where required (such as a device 510(k)); and import compliance (FSVP, Prior Notice, import-alert response). We scope the work to what your specific product actually needs.
4. Who do you help?
Both U.S. and foreign companies - manufacturers, brand owners, importers, and marketplace sellers - across food and dietary supplements, drugs (OTC and Rx), medical devices, and cosmetics. Foreign firms especially value the U.S. Agent role and end-to-end market-entry support, since they need a U.S. presence for FDA. We work with first-time entrants and established companies alike.
5. Does registering with your help mean my product is "FDA approved"?
No. FDA registration and listing are administrative - they put your establishment and products in FDA's system, but they are not FDA "approval." FDA approves only certain products (new drugs, Class III devices, biologics) and clears others (most Class II devices via 510(k)); most food, cosmetics, and dietary supplements have no premarket approval at all. We're careful to describe your status accurately - registered/listed, cleared, or approved only where it truly applies.
6. How much do your services cost?
It depends on the product, program(s), and scope, so we provide a quote. Importantly, we separate our service fee from any FDA government fees: food and cosmetic facility registration have no FDA fee, while device establishment registration carries an annual MDUFA fee and OTC drug facilities pay OMUFA fees - those are paid to FDA regardless of who does the work. We're transparent about which costs are ours and which are the government's.
7. Can you guarantee FDA approval or a specific outcome?
No - and we're upfront about it. No one can guarantee FDA decisions like a 510(k) clearance, a drug approval, or removal from an import alert; those are FDA's to make. What we can do is complete the work correctly and completely so that avoidable errors aren't the reason for a delay or denial. Be cautious of any firm promising "guaranteed FDA approval" - it's not something a consultant can promise.
8. Do you serve as a U.S. Agent?
Yes. We act as the U.S. Agent for foreign establishments across FDA's food, drug, device, and cosmetic programs - a responsive U.S.-based point of contact that meets FDA's requirements, forwards FDA communications, and helps coordinate inspection scheduling. We can handle your establishment registration alongside the U.S. Agent role so everything stays aligned. See our FDA U.S. Agents hub for details.
9. Can you help foreign companies enter the U.S. market?
Yes - it's a core focus. For a foreign company we confirm classification, complete FDA registration and listing, serve as your U.S. Agent, review labeling/claims for U.S. rules, and support the import side (initial importer, FSVP/Prior Notice for food, entry, and import-alert risk). We map the whole pathway so your product can enter and stay on the U.S. market compliantly.
10. What if I already have an FDA registration or a U.S. Agent?
We can review your existing registration to confirm it's correct and current, manage renewals, and - if you want to switch U.S. Agents - handle the change without a coverage gap. Many companies come to us to fix or take over a registration that was done incorrectly, is lapsing, or points at an unresponsive agent. We can also just review your setup and tell you if it's fine as-is.
11. What products does the FDA regulate that you can help with?
The FDA-regulated categories we cover: food and dietary supplements, human drugs (OTC and prescription), medical devices, and cosmetics. If you're not sure your product is even FDA-regulated, or which category it falls in (a common question for cosmetic-vs-drug or is-it-a-device situations), that's usually where we start - because classification determines every requirement that follows. See our "what is the FDA" overview for the big picture.
12. Do you review labeling and claims?
Yes. We review labels against the FDA rules for their category - the required panels (Nutrition Facts, Supplement Facts, Drug Facts), ingredient/INCI lists, allergen declarations, required contacts (like the MoCRA adverse-event contact), and UDI where applicable - and, critically, we review your claims, since a disease claim can turn a product into an unapproved drug. Getting labeling and claims right up front avoids recalls, detentions, and marketplace takedowns.
13. Where are you located?
We're based in Miami, Florida (18117 Biscayne Blvd, Suite 1288, Miami, FL 33160), operating as part of Retro Consultants LLC. We serve clients across the United States and internationally - our work is done through FDA's electronic systems and by coordinating with your team, so we support companies wherever they're located, including foreign firms entering the U.S. market.
14. How do I get started?
Contact us with your product and situation - what it is, its intended use and claims, whether you're domestic or foreign, and where you are in the process. We'll confirm how FDA applies to your product, identify exactly what's required, and give you a scoped quote. Reach us at info@fdaregistrationassistance.com or +1 (928) 275-8333, or use the contact page. There's no obligation to get an assessment.
15. What makes your approach different?
We aim to be accurate and transparent rather than to oversell: we tell you what FDA actually requires (and what it doesn't), keep our service fees separate from government fees, don't imply "FDA approved" where it isn't true, and won't promise FDA outcomes no one can guarantee. Where part of a task is genuinely do-it-yourself (like a free food facility registration), we'll say so. The goal is durable compliance, not slogans.
16. How can I contact FDA Registration Assistance?
Email info@fdaregistrationassistance.com or call +1 (928) 275-8333. We're an independent compliance firm serving 1,000+ companies across 135+ countries, with 15+ years of experience across FDA's food, drug, device, and cosmetic programs. Tell us about your product and we'll map the requirements and next steps.
