FDA Registration Services & Pricing
Fixed prices in U.S. dollars. No VAT, no hidden fees, no long contracts. U.S. Agent service is included for facilities outside the U.S.
Pay by card or PayPalReceipt by emailAnswers in writing
Included with every registration
- D-U-N-S and facility details checked before filing
- Filed with FDA within days of receiving your details
- U.S. Agent located in the United States
- Certificate of registration your buyers can verify online
- Reminders before every renewal
- Contact and product updates during the year at no charge
Food facility registration
$269 / year
- Registration or 2026 renewal
- U.S. Agent service
- Certificate of registration
Cosmetic facility registration
$369 / year
- Small-business exemption checked
- U.S. Agent service
- Product listing $269 each
Device establishment registration
$369 / year
- Help paying FDA's annual fee
- U.S. Agent service
- Device listing $49 each
Drug establishment registration
$369 / year
- NDC labeler code requested
- U.S. Agent service
- Drug listing $169 each
Food & dietary supplements
About this serviceFacility registration + U.S. Agent Includes U.S. Agent
FDA food facility registration, U.S. Agent service, renewal reminders and a certificate of registration.
Additional food facility (same owner)
Registration + U.S. Agent for each extra facility owned by the same company.
Food label review: Basic
Ingredient list, allergens, net quantity and name and address, with a written report.
Food label review: Standard
Everything in Basic, plus the Nutrition / Supplement Facts panel and label claims.
Food Canning Establishment (FCE) registration
Required for low-acid and acidified canned foods.
Process filing (SID)
Scheduled process filing for each canned food product and container size.
Importing food into the U.S.
About FSVPFSVP setup
A written Foreign Supplier Verification Program. Covers one foreign supplier and up to 5 products.
FSVP importer service: annual
Regovant acts as your FSVP importer for all shipments in the year. Requires FSVP setup. Lower-risk foods only.
FSVP importer service: per shipment
Regovant acts as your FSVP importer, paid per customs entry. Requires FSVP setup. Lower-risk foods only.
FSVP additional supplier
Each extra foreign supplier added to your FSVP.
FSVP additional product
Each product beyond the 5 included per setup.
Prior Notice
Filed with FDA before each food shipment arrives. You get the confirmation number.
Cosmetics (MoCRA)
About this serviceFacility registration + U.S. Agent Includes U.S. Agent
MoCRA facility registration, U.S. Agent service, renewal support and a certificate of registration.
Product listing
Lists each product with FDA, including its ingredients and Responsible Person.
Cosmetic label review
Ingredient declaration, product name, net quantity and warnings, with a written report.
Medical devices
About this serviceEstablishment registration + U.S. Agent Includes U.S. Agent
FDA device establishment registration, U.S. Agent service and yearly renewal support. FDA's own annual user fee is paid separately.
Device listing
Lists each device with FDA under your registration.
GUDID account setup
Help opening your account in FDA's device identifier database.
Device label review
Checks your device labeling against FDA rules, with a written report.
510(k) and UDI listing
Priced to your device. Send us the details for a quote.
Drugs
About this serviceEstablishment registration + NDC labeler code + U.S. Agent Includes U.S. Agent
Drug establishment registration, labeler code and U.S. Agent service.
Drug listing
Lists each drug product with FDA.
Drug label review
Checks your drug labeling against FDA rules, with a written report.
Drug Master File (DMF) + U.S. Agent
DMF submission and U.S. Agent service for the DMF holder.
Export certificates
Export certificate / Certificate of Free Sale
Help applying for an FDA export certificate, such as a Certificate of Free Sale.
Our price and FDA's fees
| Service | Regovant | Paid to FDA |
|---|---|---|
| Food facility registration | $269 / year | No FDA fee |
| Cosmetic facility registration (MoCRA) | $369 / year | No FDA fee |
| Medical device establishment | $369 / year | $13,785 for October 2026 to September 2027 |
| Drug establishment | $369 / year | No fee to register. Some facilities pay OTC monograph or generic drug fees. |
| Prior Notice | $25 / shipment | No FDA fee |
| Export certificate | $269 / certificate | FDA may charge its own fee for some certificates |
Pricing questions
Are these prices per year?
Registration and U.S. Agent prices are per facility, per year. Listings, label reviews and filings are one-time prices per item.
Do you charge extra for renewal?
No. Your yearly price covers U.S. Agent service and filing the renewal when it is due.
How can I pay?
By card or PayPal, in U.S. dollars, at checkout. You receive a receipt by email straight away.
Is there a contract?
No. You pay year by year. If you don't renew our service, it simply ends at the end of the year you paid for.
Why is FDA's device fee so much higher than your price?
FDA's annual device establishment fee is set by law and paid directly to FDA. Our price covers preparing and filing the registration and U.S. Agent service.
Do you charge for updates during the year?
No. Changes to contacts, product categories or company name, and cancelling a registration, are included free during the year you have paid for. If the facility moves to a new address or gets a new owner, FDA needs a new registration, which is charged at the normal price.
Can I get one price for several facilities or products?
Yes. Email us your list of facilities and products and we'll reply with the total.
Regovant handles U.S. FDA requirements only. FDA does not issue registration certificates: FDA records your registration in its system, and we send you a Regovant certificate of registration that anyone can verify online. Registration is not FDA approval of your products.
Not sure what you need?
Tell us about your product and we'll reply by email with the right services and a total price.