FDA Compliance Services
U.S. Agent and FDA registration support, connected to how you sell in the U.S.
Eva Commerce is your U.S. Agent from Houston through Agile 3PL, an FDA-registered facility. We help with facility registration, product listing, Prior Notice, DUNS applications, and label review across food, supplements, animal products, OTC drugs, cosmetics, and medical devices. The same partner can also grow your brand on Amazon, Walmart, and Shopify.
Call 858-315-2020
Important: Registration, listing, and U.S. Agent services are compliance filings. They do not mean a product is cleared for sale or endorsed by the FDA. Eva Commerce does not claim FDA certification or FDA endorsement for any product or facility. What you need depends on your product category, facility role, and import path.
Why Eva for FDA compliance
Most U.S. Agent firms stop at the filing. Eva is built for brands that also have to sell.
One partner for compliance and growth
Eva handles FDA U.S. Agent and registration work and can also run Amazon, Walmart, and Shopify growth under one plan. You are not handed off to a separate agency after the filing clears.
U.S. Agent from Houston
Eva acts as your U.S. Agent through Agile 3PL in Houston, an FDA-registered facility. The FDA gets a real U.S. point of contact, not a mailbox-only arrangement.
Transparent published prices
U.S. Agent, food and supplement registration, animal facility registration, DUNS, Prior Notice, and label review prices are published below. Drug, cosmetic, and medical device service prices are listed too. FDA government fees, such as the device establishment fee or OMUFA facility fees, are paid to FDA and are separate. No invented bundles.
Label review that feeds listings
When we review a label, the same facts can inform your Amazon, Walmart, or Shopify listing copy so catalog claims stay aligned with the compliant label.
How the process works
Step 1
Tell us what you sell
Share your product category, facility role (manufacture, process, pack, hold, label, or import), and whether the site is foreign or U.S.-based.
Step 2
We file and represent you
Eva prepares the filings your category needs, serves as U.S. Agent where required, and becomes the FDA’s U.S. point of contact for your foreign facility.
Step 3
Stay current and sell
We track renewals, amendments, Prior Notice filings, and listing updates. When you are ready, the same team can connect compliant labels to Amazon, Walmart, and Shopify listings.
Categories we cover
Category
Food & Beverage
Most facilities that manufacture, process, pack, or hold food for U.S. consumption must register with the FDA unless an exemption applies. Foreign food facilities must also name a U.S. Agent. Importers often need Prior Notice before each shipment arrives.
Who typically needs this
- Foreign and U.S. food manufacturers, processors, packers, and warehouses shipping into or selling in the U.S.
- Brand owners importing packaged food who need Prior Notice on each entry
- Teams that need label checks for Nutrition Facts, allergens, claims, and net quantity before marketplace listings go live
What Eva handles
- U.S. Agent designation and ongoing FDA communication
- Food facility registration and biennial renewal
- DUNS / Unique Facility Identifier support when you need a new number
- Prior Notice filing per shipment
- Basic formatting or full compliance label review
Category
Dietary Supplements
Dietary supplements sit under food facility rules and also carry supplement-specific labeling and claims requirements. Facility registration is usually required. Labels must meet structure/function claim rules, Supplement Facts formatting, and allergen disclosure.
Who typically needs this
- Supplement manufacturers and packers selling into the U.S., including private-label brands
- Foreign facilities that must name a U.S. Agent
- Brands preparing Amazon, Walmart, or Shopify catalog content that must match the compliant label
What Eva handles
- U.S. Agent service for foreign supplement facilities
- Facility registration and biennial renewal
- DUNS application support
- Prior Notice for imported supplement shipments
- Label review: basic formatting or full compliance review
Category
Animal & Veterinary
Animal food and related facilities that make, process, pack, or hold product for U.S. distribution generally need FDA facility registration. Foreign sites need a U.S. Agent. Labels and Prior Notice rules still apply when product crosses the border.
Who typically needs this
- Pet food, animal feed, and veterinary product facilities shipping to the U.S.
- Importers who must file Prior Notice on animal food entries
- Brands that need label formatting checked before a first shipment or listing
What Eva handles
- U.S. Agent designation
- Animal and veterinary facility registration ($240 biennial)
- DUNS application support
- Prior Notice per shipment
- Label review options
Category
Drugs (OTC)
OTC drug establishments that manufacture, repack, relabel, or salvage product for U.S. distribution must register. Foreign establishments need a U.S. Agent. Separately, the company that owns the NDC labeler segment requests a labeler code, and each marketed drug needs an NDC listing submitted in Structured Product Labeling (SPL) format. OMUFA guidance applies to certain OTC monograph facilities and fees.
What Eva can support
- OTC establishment registration and annual renewal window support
- Labeler code request support
- NDC / SPL product listing support
- OMUFA guidance for applicable OTC monograph facilities
- U.S. Agent representation for foreign drug establishments
Pricing: Establishment registration $440 per year. NDC/SPL product listing $290 per product, SPL included. Labeler code request: contact us. OMUFA facility fees, where they apply, are FDA government fees and are separate. Registration and listing do not mean a drug is approved by the FDA.
Category
Cosmetics (MoCRA)
Under the Modernization of Cosmetics Regulation Act (MoCRA), covered cosmetic facilities register with the FDA and renew on a two-year cycle. Responsible Persons list marketed products, including ingredients, and update those listings. Foreign facilities must designate a U.S. Agent. Facility registration and product listing are separate clocks.
What Eva can support
- MoCRA facility registration and biennial renewal
- Cosmetic product listing and listing updates
- U.S. Agent designation for foreign cosmetic facilities
- Guidance on Responsible Person vs U.S. Agent roles
Pricing: MoCRA facility registration $440 (biennial). MoCRA product listing $290 per product.
Category
Medical Devices
Device establishments that manufacture, prepare, propagate, compound, assemble, or process devices for U.S. commercial distribution generally must register and list their devices. Foreign establishments designate a U.S. Agent. Establishment registration and device listing are related but separate filings, and annual renewal windows apply.
What Eva can support
- Device establishment registration
- Device listing
- U.S. Agent representation for foreign device establishments
- Renewal and amendment support
Pricing: Device establishment registration $340 per year. Device listing $50 per device. The FDA annual establishment registration fee is a government fee paid to FDA and is separate. Registration and listing are not the same as device clearance or approval.
Transparent service pricing
Published prices for food, supplement, and animal facility services. Where the FDA charges its own user fees, those government fees are separate from Eva’s service fees.
| Service | Price | Cadence |
|---|---|---|
| U.S. Agent | $250 | Per year |
| Food or Supplement facility registration | $240 | Biennial |
| Animal & Veterinary facility registration | $240 | Biennial |
| DUNS application | $90 | One-time |
| Prior Notice | $30 | Per filing / shipment |
| Label review, basic formatting | $340 | Per label |
| Label review, full compliance | $590 | Per label |
New to FDA filings? Read our FDA Registration and U.S. Agent Guide for renewal windows, Prior Notice basics, and what each program requires.
FAQ
Do foreign manufacturers need a U.S. Agent?
In general, yes. Foreign facilities registering under food, drug, device, or cosmetic programs must name a U.S. Agent who resides or maintains a place of business in the United States. Domestic facilities typically do not need one. Eva Commerce serves as U.S. Agent from Houston through Agile 3PL.
Does registration mean my product is approved by the FDA?
No. Facility registration, product listing, NDC assignment, and U.S. Agent designation are compliance filings. They do not mean a product is approved, cleared, or certified by the FDA. Marketing language that implies endorsement is not allowed.
How often do registrations renew?
Food and many cosmetic facility registrations renew every two years. Drug and device establishment registrations generally renew every year during the October 1 to December 31 window. Product listings and Prior Notice follow their own schedules. Missing a window can interrupt imports.
What is Prior Notice?
Prior Notice is an electronic filing the FDA requires before most food shipments arrive in the United States. Eva can file Prior Notice for $30 per shipment when you provide the shipment details on time.
What is the difference between basic and full label review?
Basic formatting review ($340/label) checks required panels, layout, and common mandatory elements. Full compliance review ($590/label) goes deeper on claims, allergens, ingredient statements, and category-specific rules. Neither review is an FDA endorsement of the label. Reviewed facts can also inform your marketplace listings.
Do Amazon or Shopify sellers automatically need facility registration?
Not automatically. Selling online does not create or remove FDA obligations by itself. What applies depends on the product, what happens at your physical facility, and whether you act as manufacturer, packer, holder, importer, or Responsible Person. We map that on a call before filing anything.
Can Eva help after registration, when we need to sell?
Yes. Eva can remain your U.S. Agent and, when you want growth support, the same company can help on Amazon, Walmart, and Shopify so compliance work and channel execution stay aligned.
How do I get started?
Book a call or call 858-315-2020. Bring your product category, facility address, and whether the site is foreign or U.S.-based. We will confirm which filings apply and quote any Contact-us categories before work begins.
Ready to name your U.S. Agent or register your facility?
Talk with Eva Commerce about the filings your category needs, and how they connect to Amazon, Walmart, or Shopify when you are ready to sell. We confirm scope before any filing.