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FDA approved or FDA cleared? Getting device claims right in practice marketing

A quiet hallway at a medical practice

Practices often describe treatments and devices by their FDA status, and the exact words matter. FDA approves some products, clears others and does not approve practices at all. This guide is for practice owners and whoever writes the website, ads and social posts. It explains the difference, why it matters and how to check a device before you describe it.

  1. SearchAn adult looks for care near them.
  2. Your pageWhat you treat, who sees them, one way to book.
  3. Call or formThey call or send a request.
  4. Front deskBooks the visit and never guesses a cause.
  5. Clinical teamThe clinician decides the plan.
How a new patient request reaches your practice.

1. Approved, cleared and registered are different things

FDA’s consumer guide Is It Really FDA Approved? explains that FDA classifies medical devices by risk:

  • Approved: the highest-risk devices (Class III) generally require FDA approval of a premarket approval application, in which the manufacturer shows a reasonable assurance that the device is safe and effective for its intended uses.
  • Cleared: many moderate-risk devices (Class II) are marketed under “510(k) clearance”, once the manufacturer has shown that the device is substantially equivalent to a legally marketed predicate device.
  • Registered or listed: FDA says that mere registration of an establishment or listing of a device does not denote approval of the establishment or the device.

The same FDA guide says plainly that FDA does not “approve” health care providers, including physician offices. So “FDA-approved clinic” or “FDA-approved provider” is not accurate.

2. Why the wording matters

FDA’s rule on premarket notification is direct. Under 21 CFR 807.97, a 510(k) determination of substantial equivalence “does not in any way denote official approval of the device,” and “any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding.” That rule is written about devices, but your ads describe the same devices. Calling a cleared device “FDA approved” makes the same claim the rule calls misleading.

Advertising law points the same way. The FTC’s Health Products Compliance Guidance says health-related claims must be truthful, not misleading and supported by competent and reliable scientific evidence. An overstated regulatory status is a claim like any other.

3. How to check a device

Before you describe a device’s FDA status, look it up. FDA’s public databases are free:

Ask your device supplier for the clearance or approval number and the indications for use, and keep them on file with your marketing copy.

4. Approved or cleared for what

Clearance and approval cover specific intended uses, not every use a practice might offer. FDA’s page on dermal fillers, for example, lists the uses FDA has approved and then lists uses it has not approved, such as filler injections to increase the size of the buttocks or breasts. It also says injectable silicone is not approved for any aesthetic procedure and that needle-free devices are not approved for injecting dermal fillers. When you mention FDA status, tie it to the approved or cleared use, and do not imply that FDA status extends to other uses.

5. A wording checklist

  1. Use “FDA cleared” for 510(k) devices and “FDA approved” only where FDA actually approved the product.
  2. Name the use: “FDA cleared for [indication from the clearance]”, not a broad “FDA approved treatment”.
  3. Do not describe the practice, the provider or the clinic as FDA approved.
  4. Do not treat registration or listing as approval.
  5. Do not promise results; FDA status is not a promise of a result for any patient.
  6. Check social posts, ad copy and staff scripts as well as the website; staff may repeat what the website says.
  7. Review the wording when you change devices or the supplier updates the indications.

For other claims in your marketing, see our guides on before-and-after photos and getting more aesthetic patients.

Where MediLeadGen fits

Accurate, specific claims help patients who are already researching a treatment trust what they read and request a consultation. MediLeadGen sends practices requests from patients interested in cash-pay elective treatments, each sent to one practice with consent naming that practice, at a fixed price per delivered request.

See how it works for practices

Questions practices ask

What is the difference between FDA approved and FDA cleared?

Approval generally applies to the highest-risk (Class III) devices after a premarket approval review. Clearance applies to many moderate-risk (Class II) devices shown to be substantially equivalent to a legally marketed device through a 510(k).

Can we call a 510(k) cleared device FDA approved?

No. 21 CFR 807.97 says a 510(k) determination does not denote official approval, and that creating an impression of official approval because of it is misleading. Say “FDA cleared” and name the cleared use.

Can we say our practice is FDA approved?

No. FDA says it does not approve health care providers, including physician offices.

How do we check a device’s FDA status?

Search FDA’s 510(k), PMA and Product Classification databases, and ask your supplier for the clearance or approval number and the indications for use.

Does FDA approval cover every use of a product?

No. Approval and clearance cover specific intended uses. FDA’s dermal filler page, for example, lists uses that are not approved, such as body contouring.

General information for practice teams, not legal or regulatory advice. Check device status in FDA’s databases and review advertising with counsel and your licensing board’s rules. Last reviewed October 2026.

More resources

All resources for practices