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Permitted & Prohibited Claims

Misbranding under the FD&C Act​

A device is misbranded if its labelling is false or misleading in any particular. Key misbranding violations include:

ViolationExample
False or misleading labellingClaiming efficacy not supported by evidence
Missing required informationOmitting adequate directions for use (without exemption)
Promoting cleared device for unapproved useAdvertising a wound dressing as cancer treatment
Using "FDA approved" for a 510(k)-cleared deviceCleared ≠ approved — this is misleading
Comparative claims without substantiation"Better than Brand X" without clinical evidence

Claims permitted for cleared devices​

A 510(k)-cleared device may be promoted for its cleared indications for use. Labelling may include:

  • Efficacy claims supported by the 510(k) data
  • Comparative performance data (with substantiation)
  • Patient outcome data (if accurately representing study population)

The "intended use" risk of promotional claims​

Making a promotional claim for a new use not covered by the existing clearance/approval creates a new intended use — and may require a new 510(k) or PMA before the claim can be made.

"FDA cleared" vs "FDA approved"​

TermWhen correct to use
FDA clearedDevice went through 510(k) pathway
FDA approvedDevice went through PMA pathway
FDA authorisedMay refer to De Novo or EUA-authorised devices
FDA approved (for a cleared device)Incorrect — misbranding risk

Official resources​

A promotional claim for a use not previously cleared or approved creates a new 'intended use' under FDA's definition (21 CFR § 860.3). Example: if a 510(k)-cleared wound dressing is promoted for 'diabetic foot ulcers' but was only cleared for 'minor cuts and abrasions,' this new indication requires submission of a new 510(k) or PMA before the claim can be made. Manufacturers should consult FDA's Determining Whether a Product is a Medical Device guidance to assess whether promotional language triggers new intended use.