328 - Our client would like to have a website about the features of its medical device (a self-injection device). The website would not mention the name of the drug that goes in the device but it would mention the therapeutic area. The intended audience is patients who would be directed to the website by their HCPs. Am I correct that this website requires PAAB pre-clearance? What if the website had content only about the features of the medical device and did not mention the drug product in any way and did not mention the therapeutic area, would it then be exempt from review since the PAAB doesn't review medical devices? Or would it require pre-clearance because it is sponsored content that patients are being directed to? Thanks in advance for your response.

[Jennifer Carroll]

Federal law requires you to promote the approved name of the product within the federal category in which it was approved. If it is approved as a drug then it requires PAAB approval. If it is a medical device (i.e. a category I, II, III, or IV medical device) no approval is required.