Match the legal entity, facility location, FEI, registration status reported by the source, establishment roles and U.S. Agent where applicable.
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FDA certification check: is “FDA certified” a real FDA approval?
Use an FDA certification check when a supplier says “FDA certified.” Identify whether the claim means establishment registration, device listing, 510(k) clearance, De Novo authorization, PMA approval or another status before relying on it.
Establishment registration only. This does not verify device clearance, approval, authorization, quality or import admissibility. Verify in FDA's official database.
Quick answer
FDA certification check: a certificate is not device approval.
FDA says it does not issue medical device registration certificates or certify registration information. A facility record can confirm establishment context, but it does not establish that a particular device is cleared, approved, authorized or legally marketable for the supplier's claimed use.
Translate the supplier's wording into evidence
Match the exact model and intended use to its listing, product code and any applicable 510(k), De Novo, PMA or exemption pathway.
Use “cleared,” “approved” or “authorized” only when the corresponding FDA record supports that term for the exact device.
Important: an FEI, registration number, private certificate, FDA logo or marketplace badge is not proof that the specific device is FDA approved.
How to review an “FDA certified” supplier
- Ask the supplier to state exactly what is registered, listed, cleared, authorized, approved or exempt.
- Search the legal establishment name or FEI and compare the returned facility with the invoice, label and contract.
- Request the exact product name, model, product code and applicable premarket reference.
- Verify the establishment in FDA Registration & Listing and the device in the appropriate FDA device database before relying on the claim.
FDA certification check questions
Does FDA issue medical device registration certificates?
No. FDA states that it does not issue device registration certificates and does not certify registration information. A private certificate may record a supplier claim, but it is not an FDA document and does not prove that a device is cleared or approved.
What evidence should I request for an FDA claim?
Request the legal establishment name and FEI, the exact device name and model, and the applicable device-specific reference such as a 510(k), De Novo or PMA number when required. Verify each item in the corresponding official FDA database.