The QMN Weekly Bulletin

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 in September, 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. And, like the FDA, the FTC requires that objective claims be substantiated. “That means you can’t make a claim just because you believe it to be true, if you don’t have objective evidence in your hands at the time to make that claim,” attorney Brad Thompson of Epstein Becker Green said.

The growth in device apps and the FDA’s definitions has created a quagmire for the FDA and industry. Will all apps need FDA approval?  How long will it take, and how much money will it cost to manage the FDA approval process? 

Featuring four speakers focusing on the trends, FDA regulations, best practices for getting approval and expanding apps into the clinical setting, this Medical Device Mobile Apps
What Needs FDA Approval webinar encore will provide a detailed look at the emerging market for medical device apps. Register for this Halloween treat today!