Regulatory Affairs Certification (RAC) Practice Exam

What type of devices does the FDA regulate advertising for?

1. Restricted devices

2. Unapproved devices

3. Over-the-counter devices

4. Experimental devices

The correct answer is: Restricted devices

The FDA regulates advertising for restricted devices because these are classified as Class III devices, which require premarket approval due to the potential risks associated with their use. The advertising for these devices must provide sufficient and truthful information about their safety and effectiveness as they are subjected to more rigorous scrutiny. This is part of ensuring that consumers are protected from misleading claims and that they receive accurate information when considering the use of such devices. In contrast, while unapproved devices may also have advertising restrictions, the regulation more explicitly targets restricted devices due to their higher risk classification. Over-the-counter devices can be sold with less regulation, and experimental devices, often under clinical investigations, are typically subject to specific protocols and may not be widely advertised to the public in conventional advertising. Therefore, the emphasis on compliance and oversight in advertising is most relevant for restricted devices under FDA regulations.