FDA approved, cleared or registered: the words a listing may use

"FDA cleared" means the US Food and Drug Administration has accepted a 510(k) premarket notification for a medical device, which may then be marketed for its cleared use; "FDA approved" means the product passed a full FDA premarket review, which applies to drugs and the highest-risk devices. "FDA registered" means only that the facility making the product is registered with the FDA, and US rules say registration "does not in any way denote approval". The FDA does not approve dietary supplements or cosmetics before sale, so "FDA approved" on a supplement or cosmetic listing is untrue, and Walmart bars false FDA claims and FDA logos on listings.

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

The four FDA words describe four different things, and only two of them say anything about a product.

FDA registration and FDA listing are administrative: they tell the FDA who makes what, and where. Registration and listing are not a judgement on whether a product is safe or works. US rules for device makers, at 21 CFR 807.39, say registration of an establishment or a registration number "does not in any way denote approval", and "Any representation that creates an impression of official approval because of registration ... is misleading and constitutes misbranding."

What does FDA cleared mean for a medical device?

FDA cleared means the FDA has accepted a 510(k) premarket notification for the device. Many medical devices need 510(k) clearance before they can be sold in the US, and once cleared a device may be promoted only for the use it was cleared for. A cleared device is described as "FDA cleared", not "FDA approved".

What a medical device listing may say about the FDA:

• "FDA cleared", if the device has a 510(k) clearance, for its cleared use only.
• "FDA approved", only if the device went through FDA approval, which applies to a small group of high-risk devices.
• Nothing about registration. "Registered with the FDA" is true of a facility, but the phrase can create the impression of approval that 21 CFR 807.39 calls misleading.
• Nothing about the FDA at all, for low-risk products promoted only for general wellness, which sit outside the FDA's device rules under its general wellness policy.

The medical device rules cover what each marketplace asks of a device listing.

Can a supplement or a cosmetic say FDA approved?

No. The FDA does not approve dietary supplements or cosmetics before they are sold, so "FDA approved" on a supplement or cosmetic listing is untrue.

Supplements. A dietary supplement that makes a structure/function claim, such as "supports restful sleep", must carry a set statement under 21 CFR 101.93 that begins "This statement has not been evaluated by the Food and Drug Administration". That required statement is the opposite of an approval. The supplement rules cover structure/function claims in detail.

Cosmetics. The FDA does not approve cosmetics either. Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), cosmetic facilities register and cosmetic products are listed with the FDA, and as for devices, registration and listing are not approval. A cosmetic that claims to treat or prevent disease, or to change the body's structure, becomes a drug under US law. The cosmetics and skincare rules cover where that line sits.

Can a listing use the FDA logo?

No. A listing should never carry the FDA's logo, or anything that looks like it, in a product image, an infographic or an A+ module. Walmart bars FDA logos outright. Walmart's medical device and drug policies allow "FDA approved" or "FDA cleared" only when true. An FDA-style seal in a listing image makes the same claim as the words, often more strongly than the words do.

The same rule covers every image in a listing. An infographic with a badge reading "FDA approved", a box photo cropped to show a certificate, and an A+ banner with an FDA-style seal all make an FDA claim. Check every listing image, not only the copy.

What do Walmart and Amazon check for FDA claims?

Walmart and Amazon both restrict FDA words, and Walmart's published policies are the more specific.

What should a listing say instead of FDA approved?

When the FDA has not approved a product, the listing should say what is true and can be shown.

"FDA certified" and "FDA tested" do not describe any of the FDA's four roles for these products, which are clearing, approving, registering and listing. A listing that says "FDA certified" or "FDA tested" suggests a step the product did not go through, and a shopper will read it as approval. "FDA compliant" is vague in the same way.

Every "say" line in the table still needs proof. A test report or a certificate is what a marketplace asks for when it questions a claim, so file the proof with the product before the listing goes live.

How do you check a supplier's FDA claim?

A supplier's statement that a product is FDA cleared or approved needs checking before it goes in a listing.

1. Ask for the number. A 510(k) clearance has a number, usually starting with K. An FDA approval has a different reference.
2. Look the number up. The FDA publishes searchable databases of device clearances and approvals, linked from its premarket notification pages. Search by the number or the company.
3. Match the product. A clearance names a device, a maker and an intended use. Check that all three match the product you sell.
4. Match the use. The listing may describe only the cleared use.
5. Keep a copy of what you found, with the date, for the marketplace and for your records.

If the number does not exist, names another product, or the supplier cannot give one, the FDA claim stays out of the listing.

What does FDA registered mean on a supplier's product?

"FDA registered" on a supplier's product usually means the factory is registered with the FDA. Facility registration says nothing about the product's safety or approval, and "FDA registered" in a listing can create the impression of approval that US rules call misleading. Leave "FDA registered" out of the listing.

A cosmetic with an FDA product listing number is in the same position. Product listing under MoCRA is administrative, like registration, and a listing should not suggest that a listing number is an approval.

What if the box says FDA approved?

A box that says "FDA approved" is only as true as the document behind it. Ask the supplier for the approval or clearance. If the supplier cannot show one, the box is wrong, and the listing must not repeat the claim. A photo of the box that shows the claim makes the same claim, so a listing image of that box needs the claim out of view or a corrected box.

Is an exempt or wellness device FDA cleared?

No. Some low-risk devices are exempt from a 510(k), and an exempt device is neither cleared nor approved, so neither word applies. Describe an exempt device by what it does, for its intended use.

A product that tracks sleep and steps and is promoted only for general wellness can sit outside the FDA's device rules. A general wellness listing should say nothing about the FDA, and should keep disease and diagnosis words out of its copy.

Why does the FDA word on a listing matter?

The wrong FDA word has practical costs for a seller:

• Listings removed. Walmart bars false FDA claims and FDA logos, and limits devices to their cleared use.
• Category approval at risk. Restricted categories on Walmart and Amazon are open to vetted sellers, and a false claim gives a marketplace reason to question that approval.
• Misbranding. For devices, implying approval because of registration is misbranding under 21 CFR 807.39.
• Buyers misled. A shopper who buys because of "FDA approved" and later learns otherwise has every reason to complain.

The FDA's words are American. A device sold in Canada or the EU goes through different approvals with different names, which the medical device rules cover, so "FDA approved" is never shorthand for a product's status in another country.

A checklist for FDA words in a listing

1. Is the product a device, a drug, a supplement or a cosmetic?
2. For a device: cleared, approved, exempt or a wellness product? Use the word that matches, for the cleared use only.
3. For a supplement or a cosmetic: never "FDA approved".
4. No "registered with the FDA" that could imply approval.
5. No FDA logo in any listing image.
6. The supplement statement wherever a structure/function claim appears.
7. Proof on file for every claim the listing makes.

How Commicorn helps

• FDA claims marked. On Amazon, a keyword such as "FDA approved" or "FDA cleared" comes with a line saying a valid certificate is needed, and a disease claim on a supplement is kept out, with the reason shown.
• Your label, as printed. On the Untouched product route the pixels of your photo are never redrawn, so the statements on your packaging stay exactly as printed.
• Copy from your facts. The listing copy is written from the details you give us; read every health claim against the checklist above before you export.

Commicorn marks FDA words before they reach your listing. Start free.

Questions sellers ask

Is FDA cleared the same as FDA approved?

No. FDA cleared means the FDA accepted a 510(k) premarket notification for a device, which may then be marketed for its cleared use; FDA approved means the product passed a full premarket review, which applies to drugs and the highest-risk devices.

Can a dietary supplement listing say FDA approved?

No. The FDA does not approve dietary supplements before sale, and a supplement making a structure/function claim must carry the statement "This statement has not been evaluated by the Food and Drug Administration".

Does FDA registered mean a product is safe?

No. FDA registration means the facility is registered with the FDA, and 21 CFR 807.39 says registration "does not in any way denote approval".

Can I put the FDA logo on a product image?

No. Walmart bars FDA logos on listings, and an FDA-style seal in an image makes the same claim as the words.

What is a 510(k)?

A 510(k) is the premarket notification a maker submits to the FDA for many medical devices; once the FDA clears it, the device may be marketed for its cleared use, and the clearance number usually starts with K.