Advertising & Promotional Claims (FDA/FTC)
Dual FDA/FTC jurisdiction
Medical device advertising is subject to oversight by both FDA and the Federal Trade Commission (FTC):
- FDA — has primary jurisdiction over labelling and prescription device advertising, including promotional materials directed at healthcare professionals
- FTC — has primary jurisdiction over consumer advertising of OTC devices (television, print, online consumer ads)
US-unique
The FDA/FTC shared jurisdiction over device advertising is a US-specific feature. In practice, FDA takes the lead on most healthcare professional-directed promotion.
What FDA considers promotional labelling
FDA's definition of labelling is broad — it includes promotional materials accompanying a device:
- Brochures, detail aids, and sales representatives' materials
- Website content directed at healthcare professionals
- Social media content for prescription devices
- Conference presentations and symposia materials
Off-label promotion
Off-label use of a device (use outside the cleared/approved indications) by healthcare professionals is not illegal. However, manufacturer promotion of off-label use is a violation of the FD&C Act and can result in FDA enforcement action.