Developers of medical device mobile apps don’t just need to worry about the FDA’s advertising and promotion regulations, they also must ensure any marketing claims comply with a new FTC guideline. But most of the FTC requirements mesh closely with FDA standards, one expert said. The FTC guideline, released last week, focuses on truthful advertising and privacy concerns. For example, claims about what an app does must be clear and accurate from the point of view of an average user, not just a software developer.
Devices & Diagnostics Letter