What is the difference between FDA-approved, FDA-cleared and FDA-registered?

Approved

FDA's consumer update on the phrase describes approval as the route for drugs and biologics, and for higher-risk devices through premarket approval. A drug that is FDA-approved has been through an application FDA reviewed for that product and use. Approval is specific to the product and the use; it is not a general endorsement of a company or an ingredient.

Cleared

FDA uses clearance for devices that go through a 510(k) premarket notification. FDA's 510(k) page says the device may not be marketed until the submitter receives an order finding it substantially equivalent to an already-marketed device. Clearance is a different standard from premarket approval.

The regulation at 21 CFR 807.97 says a substantial equivalence determination does not in any way denote official approval of the device, and that a representation implying approval on that basis is misleading and misbrands the device.

Registered or listed

Registration and listing put a facility or product in FDA's records. FDA's consumer update repeats that this does not denote approval. We cover the claim in more detail on a separate page.

Dietary supplements

FDA says that by statute it does not approve dietary supplements for safety and effectiveness. Many can be marketed without notifying FDA, and some new dietary ingredients require a notification 75 days before marketing. FDA's approach is largely after products reach the market.

Other phrases with no FDA definition we found

Terms such as FDA-compliant or FDA-grade appear in marketing. We did not locate an FDA page defining them, so they are claims to ask about, not statuses FDA recognizes. A claim that matters can be checked against FDA's own databases for the specific product or firm.