FDA Establishment Registration
What FDA establishment registration is, who must register, how it differs by program, and the U.S. Agent and listing pieces that go with it.
Key Takeaways
- Facility-level requirement — registers your establishment in FDA's system.
- Applies across all four programs — under different rules, systems, and cadences.
- Registration ≠ listing — listing identifies your products, separately.
- Renewal differs — food & cosmetics biennial; drugs & devices annual.
- Foreign establishments also need a U.S. Agent.
- Registration is not FDA approval — it identifies your facility, nothing more.
What Establishment Registration Is
Registration is administrative and facility-level — it puts your establishment (facility) into FDA's system so FDA knows who you are and what you make. Two things to keep straight:
- Registration ≠ listing. Registration identifies the facility; listing identifies the products. Drug, device, and cosmetic programs require both; food requires facility registration
- Registration ≠ approval. Being registered doesn't mean FDA reviewed, cleared, or approved your product — your product still needs its own premarket pathway where one applies
- Per facility and role — each facility registers, and roles (manufacturer, packer, importer, spec developer) matter
- Foreign establishments also designate a U.S. Agent
Registration Differs by FDA Program
| Program | Rule / system | Listing? | Renewal | FDA fee |
|---|---|---|---|---|
| Food / supplement | 21 CFR Part 1 (Subpart H) | Facility only | Biennial | None |
| Drug (OTC/Rx) | 21 CFR Part 207 | NDC / drug listing | Annual | OMUFA (OTC facilities) |
| Medical device | 21 CFR Part 807 (FURLS) | Device listing | Annual | MDUFA establishment fee |
| Cosmetic | MoCRA (Cosmetics Direct) | Product listing | Biennial | None (currently) |
Register in the Right Program
Each program has its own dedicated registration page with the full detail:
Food & supplements
Food facility registration — biennial, no fee.
Food →Drugs (OTC/Rx)
Drug establishment registration + NDC listing.
Drug →Medical devices
Device registration + listing (FURLS, MDUFA fee).
Device →Cosmetics
MoCRA facility registration + product listing.
Cosmetics →Registration Is Not Approval — and Not a Certificate
Two misconceptions cause real problems:
- "Registered" ≠ "FDA approved." Registration is administrative; it confers no FDA review, clearance, or approval. Marketing a product as "FDA approved" because it's registered is misleading (and for devices, implying approval via registration is prohibited under 21 CFR 807.39)
- FDA doesn't issue a "registration certificate." Registration shows up as a confirmation and identifiers (like an FEI) in FDA's system — third parties selling official-looking "FDA registration certificates" are not endorsed by FDA
Common Registration Mistakes
- Registering in the wrong program — because the product wasn't classified first
- Registering but not listing the products (drug/device/cosmetic)
- Missing a renewal — different programs have different cadences
- Assuming one registration covers multiple categories — each program is separate
- Foreign firm with no valid U.S. Agent on file
- Treating registration as "FDA approved" or buying a fake certificate
Get Your FDA Establishment Registered
FDA Registration Assistance completes FDA establishment registration and product listing across programs — food, drug, device, and cosmetic — in the correct FDA systems, coordinates any government fees, provides U.S. Agent service for foreign establishments, and keeps your renewals on a single calendar. We also handle the classification and labeling/claims work that has to be right for the registration to be correct.
Contact us at info@fdaregistrationassistance.com or call +1 (928) 275-8333 for a quote. An independent compliance firm serving 1,000+ companies across 135+ countries, with 15+ years of experience.
Frequently Asked Questions — FDA Establishment Registration
1. What is FDA establishment registration?
FDA establishment registration is a facility-level requirement: a business that manufactures, processes, packs, or holds an FDA-regulated product generally has to register its establishment (facility) with FDA, which puts it in FDA's system. It applies across food, drug, device, and cosmetic programs, but under different regulations, systems, renewal schedules, and (for some programs) fees. Registration is administrative - it identifies your facility to FDA; it is not FDA approval or clearance of your product.
2. Who has to register with FDA?
Broadly, establishments (facilities) that make or handle FDA-regulated products: food facilities (manufacture/process/pack/hold food), drug establishments, device establishments, and - under MoCRA - cosmetic facilities. Both domestic and foreign facilities register, and foreign facilities also designate a U.S. Agent. The exact who/what depends on the program and your role (manufacturer, packer, importer, etc.). Some roles and products are exempt, so confirm your specific obligation.
3. Is establishment registration different from product listing?
Yes. Registration is at the establishment/facility level - it identifies the facility. Listing is at the product level - it identifies the specific products (drugs, devices) made there. Drug and device programs require both registration and listing; cosmetics under MoCRA require facility registration and product listing; food requires facility registration (there's no separate "food listing" in the same sense). So for most programs you do two related things: register the facility and list the products.
4. How does registration differ by FDA program?
Food: food facility registration (21 CFR Part 1, Subpart H), biennial renewal (even years, Oct 1–Dec 31), no registration fee. Drug: drug establishment registration (21 CFR Part 207), annual, with NDC/drug listing and OMUFA facility fees for OTC monograph facilities. Device: device establishment registration (21 CFR Part 807), annual, with device listing and an annual MDUFA establishment fee (a government fee). Cosmetics: MoCRA facility registration and product listing, biennial. Each uses its own FDA system.
5. Is there a fee to register with FDA?
It depends on the program. Food facility registration has no FDA fee. Cosmetic facility registration under MoCRA currently has no fee. Device establishment registration has an annual MDUFA establishment fee (a government fee - $11,423 for FY2026), and OTC drug facilities pay OMUFA facility fees. These are government fees paid to FDA, separate from any consulting fee. Confirm the current fee for your program, since fee amounts change each fiscal year.
6. How often do I have to renew?
Renewal cadence differs by program: food facility registration renews biennially (every two years, in even-numbered years, during Oct 1–Dec 31); cosmetic facility registration renews biennially under MoCRA; and drug and device establishment registration renew annually (October–December). Missing a renewal window can leave you not duly registered - which can make products misbranded and cause import problems - so track the correct cycle for each program you're in.
7. Do foreign companies register too?
Yes. Foreign establishments that make or handle FDA-regulated products for the U.S. market register just like domestic ones - and they must additionally designate a U.S. Agent (FDA's U.S.-based contact for the foreign facility). Without a valid U.S. Agent, a foreign registration generally can't be completed, and products can be held at import. So a foreign company's registration package includes the registration itself plus the U.S. Agent.
8. Does registering mean my product is FDA-approved?
No - this is the most important misconception. Registration (and listing) are administrative steps that identify your facility and products to FDA. They do not mean FDA reviewed, cleared, or approved your product. FDA doesn't approve most establishments or facilities, and for devices, using registration to imply approval is specifically prohibited (21 CFR 807.39). Your product still needs whatever premarket pathway applies (e.g., a device 510(k), drug approval/monograph compliance). Registration is not approval.
9. What is a registration number / FEI?
When you register, FDA associates your establishment with identifiers - commonly an FEI (FDA Establishment Identifier) and program-specific registration numbers. These confirm your facility is in FDA's system. Note that FDA does not issue an official "registration certificate"; the registration is reflected as a confirmation and number(s) in FDA's system. Be wary of third parties selling "FDA registration certificates," which FDA neither issues nor endorses.
10. When do I need to register — before I make or sell?
Timing varies by program, but generally you register at or around the time you begin covered operations (for devices, typically within 30 days of starting), and you must be registered to lawfully market/import. Just as important, registration should follow correct classification: for a device you need the class/product code first; for a cosmetic vs OTC drug you need to know which you are. Register in the right program once you've confirmed what your product is.
11. Can I register more than one product category under one registration?
No - each FDA program is separate. If you make products in more than one category (say a supplement, an OTC drug, and a cosmetic), you register in each applicable program, each with its own system, renewal cadence, and (where applicable) fee. They don't merge into a single FDA registration. One provider can manage all of them together, but the registrations themselves are program-by-program.
12. What happens if I don't register (or let it lapse)?
Operating without required registration - or letting a registration lapse by missing the renewal window - can render your products misbranded and unlawful to market, and can cause import shipments to be detained or refused. FDA can also take enforcement action. Because renewal windows and cadences differ by program, lapses are a common and avoidable problem; tracking each program's cycle (and paying any fee on time) keeps you "duly registered."
13. Is registration the same as GMP/quality compliance?
No. Registration identifies your facility to FDA; it doesn't certify that you meet good manufacturing practice (GMP) or quality-system requirements. Those apply separately (for example, 21 CFR Part 111 for supplements, Part 211 for drugs, the QMSR for devices). A registered facility can still be non-compliant on quality. So registration is one piece; the underlying manufacturing/quality compliance is another, and both matter.
14. Which registration page should I use for my product?
Use the program that matches your product: food/dietary supplement facilities, OTC/drug establishments, medical device establishments, or cosmetic facilities. Each has its own dedicated page with the specifics, linked from this hub. If you're unsure of the category - cosmetic vs OTC drug, or whether a product is a device - resolve the classification first, because it determines which program you register in.
15. Is registration a one-time thing?
No. Registration is maintained, not one-and-done: you renew on your program's cadence (biennial for food/cosmetics, annual for drugs/devices), pay any applicable fee each cycle, keep your information (and U.S. Agent, if foreign) current, and update listings as products change. Treating registration as a one-time task is a common way companies fall out of "duly registered" status without realizing it.
16. How does FDA Registration Assistance handle establishment registration?
We complete FDA establishment registration and product listing across programs - food, drug, device, and cosmetic - in the correct FDA systems, coordinate any government fees, provide U.S. Agent service for foreign establishments, and keep your renewals on a single calendar. We also handle the classification and labeling/claims work that has to be right for the registration to be correct. We're an independent compliance firm serving 1,000+ companies across 135+ countries with 15+ years of experience. Contact info@fdaregistrationassistance.com or +1 (928) 275-8333.
