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:
| Violation | Example |
|---|---|
| False or misleading labelling | Claiming efficacy not supported by evidence |
| Missing required information | Omitting adequate directions for use (without exemption) |
| Promoting cleared device for unapproved use | Advertising a wound dressing as cancer treatment |
| Using "FDA approved" for a 510(k)-cleared device (correct term is "FDA cleared") | Cleared ≠ 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"
| Term | When correct to use |
|---|---|
| FDA cleared | Device went through 510(k) pathway |
| FDA approved | Device went through PMA pathway |
| FDA authorised | May 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.