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Home/Industry-Specific/FDA Registration
Industry-Specific
Food · drug · cosmetic · medical device

FDA facility registration. Through the FURLS portal.

FDA requires facility registration for: food facilities (manufacturing, packaging, processing, storage of food consumed in US), drug establishments (manufacturers, repackagers, relabelers), cosmetic facilities (after MoCRA), and medical device establishments (manufacturers, specification developers, contract manufacturers). Registration through FURLS portal. Biennial renewal required. Foreign facilities also need US Agent. We register and manage renewals.

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All 50 states + DC 60-day money-back SOC 2 Type II
How it works

How we handle FDA Registration, end-to-end.

FDA requires facility registration for: food facilities (manufacturing, packaging, processing, storage of food consumed in US), drug establishments (manufacturers, repackagers, relabelers), cosmetic facilities (after MoCRA), and medical device establishments (manufacturers, specification developers, contract manufacturers).

1

Facility category

Food (FDA Food Facility Registration), drug (Drug Establishment Registration), cosmetic (MoCRA, since 2023), medical device (Device Establishment Registration). Each has different forms and requirements.

2

FURLS account + registration

Create FURLS (Food, Drug, Device Registration and Listings System) account. Complete category-specific registration. US Agent designation if foreign facility.

3

Product listings

Many categories require product listings (drug listing, device listing, cosmetic product listing). We coordinate listing in addition to facility registration.

4

Biennial renewal

All FDA registrations renew every 2 years. We track and refile. Lapse triggers FDA enforcement attention.

What we'll set up for you

A clean handoff, in four steps.

You give us the basics. We handle the state, the IRS, and the compliance clock so you can focus on the business.

01 · Name + Brand

A name that's actually available.

Real-time check against the state register, USPTO trademark database, and matching domains.

02 · State filing

Filed with the Secretary of State.

We submit your Articles, pay the state fee on your behalf, and return the stamped certificate.

03 · Federal IDs

EIN + the right tax setup.

Federal Employer ID with the IRS, plus state tax accounts when your business needs them.

04 · Stay compliant

Registered Agent + deadline tracking.

Your agent on file in every state, with every renewal and annual report tracked in one calendar.

Pricing

Transparent fda registration pricing.

Government fees pass through at cost. No upsells.

Single facility

$999
One facility registration.

Initial registration for one facility, category-specific. FURLS account setup, registration submission, confirmation tracking. US Agent for foreign facilities additional $499/yr.

Get started

Multi-product listings

$1999
Registration + product listings.

Facility registration plus product listings (drug listings, device listings, cosmetic product listings). For categories where product listings are required in addition to facility registration.

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Compliance subscription

$499
Annual subscription.

Annual subscription for ongoing FDA compliance: biennial renewal, listing updates, US Agent service (for foreign facilities), enforcement letter response.

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FAQ

About the FDA Registration Service.

What is FDA registration?
FDA registration is the requirement for many businesses that manufacture, process, pack, or hold food, drugs, cosmetics, medical devices, or similar products to register with the Food and Drug Administration, and sometimes list their products. It is separate from forming your entity. We keep your entity organized alongside it.
Who needs to register with the FDA?
Businesses in FDA-regulated industries, food facilities, drug and device manufacturers, cosmetics companies, and others, generally must register, with the specific requirements depending on the product and activity. We flag whether your business is in an FDA-regulated category so you register where it is required.
Is FDA registration the same as FDA approval?
No: registration tells the FDA who you are and what you do, while approval or clearance is a separate, often rigorous process for certain products like drugs and some devices, so they are very different. We flag which applies to your product so you do not confuse registering with getting a product approved.
What does FDA registration involve?
Depending on the product, it can involve registering your facility, listing products, appointing a US agent for foreign firms, and meeting labeling and safety requirements, so it varies by industry. We flag what your product category requires so your registration and related obligations are handled correctly.
Do food businesses need FDA registration?
Many do: facilities that manufacture, process, pack, or hold food for US consumption generally must register with the FDA, though some retail and small operations have exemptions. We flag whether your food business needs to register so you meet the requirement where it applies.
Do foreign companies need FDA registration?
Often yes, plus a US agent: foreign firms in regulated categories that market products in the US generally must register and appoint a US agent, so international businesses have added requirements. We flag these so a foreign company selling regulated products in the US is properly registered. See international founders.
What are the ongoing obligations?
FDA-regulated businesses face renewal of registration, product listing updates, labeling rules, and safety and recordkeeping requirements, so registration brings continuing compliance. We keep your entity and records organized and flag the obligations so your business stays compliant over time.
What happens if I don't register when required?
Marketing FDA-regulated products without required registration can lead to enforcement, import refusals, and penalties, so registration is essential before those activities. We flag the requirement so your business does not distribute regulated products before registering with the FDA.
Can File.Business help my FDA-regulated business?
We form the entity, obtain the EIN, provide the registered agent, and flag the FDA registration and related requirements your product category involves, coordinating with the regulatory specialists who handle the FDA process, so your regulated business is set up correctly.

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