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Is There an FDA Registration Certificate? What FDA Actually Issues and How to Prove Registration

FDA does not issue registration certificates to food facilities, cosmetic facilities or device firms, and it does not recognize private ones. Here is what proves registration in each FDA program and what buyers can check.

Author:
FDABridge Regulatory Team
Published:
Read time:
5 minutes

Importers, marketplaces and distributors often ask a supplier for its FDA certificate. The request is understandable, but the document does not exist in the form many people expect. FDA does not issue registration certificates to food facilities, cosmetic facilities or medical device firms, and for food facilities it states plainly that it does not recognize certificates printed by private companies. What FDA assigns is a registration number, and the evidence that a business is registered depends on the FDA program involved.

Food facilities: a registration number, not a certificate

FDA's guidance on food facility registration is explicit. Food facilities do not need a certificate of registration; FDA does not issue a certificate of registration or product status, for example for low-acid canned foods, and it does not recognize such a certificate issued by a private business. FDA also reminds private issuers that the FDA logo is for official FDA use and not for private-sector materials. FDA considers a copy of a valid registration to be proof of registration, and the assignment of a registration number means only that the facility is registered. It does not convey FDA approval or endorsement of the facility or its products.

Three further points from FDA's guidance help when a buyer asks questions. FDA charges no fee for food facility registration, renewal or updates. FDA does not require a facility to use a third-party registrar. And food facility registration information is confidential: FDA does not publish it, so a buyer who wants to confirm status has to ask the facility. Food facility registrations are renewed between October 1 and December 31 of each even-numbered year; the current cycle is covered in the 2026 food facility registration renewal guide.

Cosmetic facilities and products under MoCRA

The same principle applies to cosmetics. FDA states that it does not issue certificates or other documents to verify compliance for cosmetic product facility registration or product listing, and that the assignment of a facility registration number or product listing number does not indicate FDA approval of the facility or its cosmetic products. Facility registrations must be renewed every two years, and product listings must be updated annually. In Cosmetics Direct, FDA offers a biennial renewal for registrations with changes and an abbreviated renewal for registrations without changes. See the 2026 MoCRA cosmetic facility registration renewal guide.

Drug establishments: status is published in DECRS

Drug registration works differently in one important respect: FDA publishes it. Registered drug establishments appear in FDA's Drug Establishments Current Registration Site (DECRS), and listed drugs appear in the NDC Directory. A buyer can therefore check drug establishment and listing status directly instead of relying on a document supplied by the manufacturer. Drug establishments renew every year between October 1 and December 31, as explained in the drug establishment renewal and blanket no-changes certification guide.

Medical devices

FDA states that businesses that register medical device facilities do not receive a certificate from FDA, and that FDA does not issue any type of device registration certificate to medical device facilities.

What to send a buyer instead of a certificate

  • Food: the facility registration number and a copy of the valid registration, plus U.S. agent details if the buyer needs them.
  • Cosmetics: the facility registration number and the product listing numbers from Cosmetics Direct.
  • Drugs: the establishment's DUNS or FEI number so the buyer can look it up in DECRS, and the NDCs so the buyer can check the NDC Directory.
  • Any product: do not describe a registration as an FDA approval or certification, and do not place the FDA logo on certificates, packaging or marketing material.

What a professional service adds

Food facility registration carries no FDA fee and can be done directly with FDA. What a specialist adds is accuracy and continuity: identifying which facilities and products must be registered or listed, keeping the U.S. agent, DUNS and FEI identifiers and product data consistent across FDA systems, filing renewals on time, and producing a clean record when a buyer, importer or marketplace asks for evidence. FDABridge provides these services for food (food facility registration), cosmetics (cosmetic facility registration and cosmetic product listing) and drugs (drug establishment registration), with U.S. agent coverage in selected registration services (U.S. Agent service).

For identifiers, see FDA registration numbers explained: FEI, DUNS and facility identification; for questions to ask any registration provider, see red flags and questions to ask an FDA registration service; and for the terms to compare in an offer, see what to check before you pay for FDA registration. Export certificates are a separate subject, covered in when foreign manufacturers need FDA export certificates.

Sources: FDA, Questions Regarding Whether Food Facilities are Required to Pay Registration Fees and Private Businesses Claiming or Suggesting an Affiliation with FDA (https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/questions-regarding-whether-food-facilities-are-required-pay-registration-fees-and-private); FDA, Registration and Listing of Cosmetic Product Facilities and Products (https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products); FDA, Are There FDA Registered or FDA Certified Medical Devices? (https://www.fda.gov/medical-devices/consumers-medical-devices/are-there-fda-registered-or-fda-certified-medical-devices-how-do-i-know-what-fda-approved).