Identifies a facility in FDA device registration data. It does not approve the products made or sold there.
Claim verification
FDA certification check: verify the claim behind the label.
When a supplier says “FDA certified,” identify the establishment first and then ask for the device-specific regulatory evidence that supports the sales claim.
Quick answer
“FDA certified” is not enough information to approve a purchase.
First determine whether the seller means establishment registration, device listing, 510(k) clearance, De Novo authorization or PMA approval. Use the lookup for the facility record, then verify the exact device evidence directly with FDA. Registration is not FDA approval or endorsement.
Translate the claim into evidence
Relates to a specific product and regulatory pathway. Ask for the exact reference, not a generic certificate.
Can help document the claim but must be reconciled with the official establishment and device records.
Important: do not treat an FEI, registration number, logo or marketplace badge as 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 or approved.
- Look up the legal establishment name or FEI and compare the returned facility.
- Request the product-specific regulatory reference and match it to the exact model being purchased.
- Verify both records directly with FDA before importing or making approval claims downstream.
FDA claim questions
Can a registered facility say every product is FDA approved?
No. Establishment registration and device-specific clearance or approval are different. The exact product claim needs its own evidence.
What if the supplier only provides an FEI?
Use it to verify the establishment, then request the device-specific regulatory reference that applies to the product and intended use.