FDA Cleared vs FDA Approved: Not the Same Claim

These are different regulatory states, and using the wrong word in marketing is a labelling problem, not a style choice. FDA has sent warning letters over exactly this.

The five states

Approved. FDA reviewed the product's own evidence and concluded it is safe and effective. Drugs approved through an NDA or BLA, and Class III devices through PMA.

Cleared. FDA agreed the device is substantially equivalent to something already on the market. That is a comparison, not an independent finding of safety and effectiveness. This is 510(k).

Granted. A De Novo request was granted, creating a new classification for a novel low-to-moderate risk device with no predicate.

Registered and listed. The establishment told FDA it exists and what it makes. This is an administrative obligation. It carries no judgement about the product whatsoever, and "FDA registered" as a marketing claim is the one FDA objects to most often.

Marketed under a monograph. An OTC monograph drug conforming to its monograph is legally marketed with no product-specific FDA review at all.

Why the distinction is not pedantic

A 510(k) clearance says your device is like an existing one. It does not say FDA studied your device and found it safe and effective, because FDA did not. Advertising it as "FDA approved" claims a review that never happened.

The same logic runs through the others. "FDA registered" on a supplement label implies an evaluation that establishment registration explicitly is not. Registration is not an endorsement, and FDA says so in those words.

What you can say

• A 510(k) device: "cleared by FDA", or "510(k) cleared".
• A De Novo device: "granted" or "De Novo authorised".
• A PMA device or an approved drug: "approved by FDA".
• An establishment: describe it as registered as a fact about the establishment, never as a property of the product.

Avoid "FDA certified" entirely. FDA does not certify products.