Quick Answer
FDA registration is required for facilities and certain products entering the US, including medical devices, food, drugs, and cosmetics. Registration is not FDA 'approval'. Verify a supplier's claims directly in the FDA's official databases (such as the device registration and 510(k) databases) rather than trusting a certificate.
How to Verify FDA Claims
FDA registration of a facility is different from FDA clearance or approval of a product. For medical devices, confirm the specific device and 510(k) clearance number in the FDA device databases; for food facilities, confirm facility registration. Be wary of suppliers presenting an 'FDA certificate' — the FDA does not issue certificates for most registrations.
- Facility registration is not product approval
- Verify device clearances in the FDA 510(k) database
- Confirm the specific model, not just the manufacturer
- The FDA does not issue generic 'certificates'
Key Takeaways
- FDA registration is not the same as approval.
- Verify the specific product, not just the facility.
- Use the official FDA databases to check claims.
- Be cautious of supplier 'FDA certificates'.
Frequently Asked Questions
What does FDA registration mean?
It means a facility or product is registered with the US Food and Drug Administration as required for the US market. Registration is an obligation, not an endorsement, and is different from FDA clearance or approval.
Is FDA registration the same as FDA approval?
No. Many products only require registration, not approval. Some products, such as certain medical devices and drugs, require clearance or approval through specific FDA processes like 510(k) or PMA.
How do I verify a supplier's FDA claim?
Check the official FDA databases — for example the device registration and 510(k) databases — for the specific product and facility. Do not rely on an 'FDA certificate', which the FDA generally does not issue.
Do food products from China need FDA registration?
Food facilities exporting to the US generally must register with the FDA, and shipments must meet FDA requirements. Verify facility registration and ensure the product itself complies.
Can Plutonia verify FDA registration?
Yes. Plutonia checks FDA facility registration and device clearances in the official databases and helps ensure products meet US requirements. Submit the product details to start.