Register With FDA — Start Your Registration
Tell us about your product and we'll confirm exactly what FDA requires, then handle your registration — across food, drugs, medical devices, and cosmetics.
- All four programs — food & supplements, drugs, devices, cosmetics
- Foreign companies welcome — we serve as your U.S. Agent
- Transparent — our fee is separate from any FDA government fee
- Straight answers — registration is not FDA "approval," and we'll say so
Start your FDA registration
Fill this out and we'll get back to you with what's required and a quote. No obligation.
Thanks — we've got your details.
We'll review your product and reply with what's required and a quote. For anything urgent, email info@fdaregistrationassistance.com or call +1 (928) 275-8333.
All Four FDA Programs
Food & supplements
Facility registration (free from FDA), DUNS, biennial renewal.
Drugs (OTC/Rx)
Establishment registration & NDC listing.
Medical devices
Registration & listing; U.S. Agent; classification.
Cosmetics
MoCRA facility registration & product listing.
From Form to Registered
- You submit the form. Just the basics — we take it from there.
- We confirm the category & requirements. What FDA actually requires for your product.
- We send a scoped quote. Our service fee, kept separate from any FDA government fee — no obligation.
- We register you. Facility registration, listing, DUNS, and U.S. Agent (for foreign firms) — done through FDA's systems.
A Few Honest Things
- Registration isn't approval. It places you in FDA's system; FDA doesn't "approve" most products, and we won't imply it does
- Government fees are separate. Food/cosmetic registration is $0 from FDA; devices (MDUFA) and OTC drugs (OMUFA) have government fees — distinct from our service fee
- FDA issues a number, not a certificate. Be wary of anyone selling an "FDA registration certificate"
- No guaranteed outcomes. We do the work correctly and promptly; we don't promise "guaranteed FDA approval" or a fixed FDA timeline
Frequently Asked Questions
1. What happens after I submit the form?
We review your details, confirm how FDA applies to your product (the category and what's actually required), and send you a scoped quote and next steps. There's no obligation - the first step is just an assessment. If part of what you need is genuinely do-it-yourself (like a free food facility registration), we'll tell you that too. Submitting the form starts the conversation; it doesn't commit you to anything.
2. Does submitting this register me with FDA immediately?
No - this form starts your engagement with us; it doesn't file an FDA registration by itself. FDA registration is done through FDA's systems after we confirm your product's category and gather the required information (including a DUNS number for food facilities). We move quickly once you're ready, but "register now" means we start now - not that FDA registers or approves anything instantly.
3. How much does FDA registration cost?
It depends on your product and program, so we quote based on scope. Importantly, we keep our service fee separate from any FDA government fee: food and cosmetic facility registration have no FDA fee ($0), while device establishment registration carries an annual MDUFA fee and OTC drug facilities pay OMUFA fees - those go to FDA regardless of who does the work. We're transparent about which costs are ours and which are the government's.
4. What do I need to provide?
To start, just the basics on the form: your contact details, whether your company is U.S.-based or foreign, your product type, and a short description. To complete a registration we'll later need your establishment details and a DUNS number (free, and we can help you get one). Foreign facilities also need a U.S. Agent, which we can provide. We'll tell you exactly what's needed for your specific product.
5. Does registration mean my product is FDA-approved?
No. FDA registration is administrative - it places your establishment (and products, where listing applies) in FDA's system. It is not FDA "approval," and FDA doesn't approve most products. So being registered means registered, not approved or cleared. We're careful to describe your status accurately and won't imply "FDA approved" where it isn't true.
6. I'm a foreign company — can you help?
Yes - foreign companies are a core focus. We complete your FDA registration, serve as your U.S. Agent (required for foreign establishments), review your U.S. labeling, and support import compliance so your product can enter the U.S. market. Just indicate on the form that your company is based outside the U.S., and we'll map the full U.S.-side setup you need.
7. Which products do you register?
Across all four FDA programs: food and dietary supplements, drugs (OTC and prescription), medical devices, and cosmetics. If you're not sure which category your product falls in (a common question for cosmetic-vs-drug or is-it-a-device cases), select "not sure" on the form - confirming the category is part of what we do, and it determines everything that follows.
8. Is my information kept private?
We use the details you submit only to respond to you about your FDA registration. We don't sell your information. If you'd rather not use the form, you can email us directly at info@fdaregistrationassistance.com or call +1 (928) 275-8333. Share only what you're comfortable with to start - we can gather the rest once we're working together.
9. Can you guarantee FDA approval or a timeline?
No - and we're upfront about it. No one can guarantee FDA outcomes (like a device 510(k) clearance or a drug approval), and registration timing depends on factors like obtaining a DUNS. We can complete the work correctly and promptly, but we won't promise "guaranteed approval" or a fixed FDA timeline, because those aren't within any consultant's control. Honest speed beats overpromising.
10. How do I reach you without the form?
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, based in Miami, Florida. Whether you use the form, email, or phone, the first step is the same: tell us about your product and we'll confirm what's required.