Regulatory Affairs Certification (RAC) Practice Exam

Should a surgeon's independent video of an investigational device on YouTube be considered misbranding?

1. Yes, if it shows the device in use

2. No, if no claims are made about safety or efficacy

3. Yes, regardless of claims made

4. No, as it promotes the device

The correct answer is: No, if no claims are made about safety or efficacy

The reasoning behind considering that a surgeon's independent video of an investigational device on YouTube is not misbranding if no claims are made about safety or efficacy is grounded in the definitions and regulations established by the FDA regarding promotional materials and investigational devices. Misbranding occurs when the labeling or advertising of a product is misleading or false, particularly concerning its safety or efficacy. If the surgeon's video does not make any explicit claims regarding how safe or effective the investigational device is, then it does not mislead viewers in that sense. Therefore, the absence of specific statements concerning safety and efficacy means that the video is more of a demonstration of the device’s use rather than a promotional claim that could lead to consumer misunderstanding. In contrast, if there were claims mentioned in the video about the device's performance, safety, or effectiveness, it could lead to regulatory scrutiny and potentially be classified as misbranding. This is particularly important given that investigational devices are subject to strict regulations and controls regarding how they can be marketed and discussed in public forums. Thus, as long as the video remains straightforward without assertions about the device's benefits or risks, it does not fall into the category of misbranding.