FDA Medical App Regulation and the Art of Intended Use


Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, authored an article in MobiHealthNews, titled “FDA Medical App Regulation and the Art of Intended Use.”

Following is an excerpt:

With the growth of health apps, entrepreneurs often need to determine if FDA regulates their particular mobile app. As I’ve explained in other posts and indeed in a book, that question has a number of facets to it, but in this post I want to focus on the most important – the intended use of the app. This concept of intended use is indeed not just the determining factor in deciding whether FDA regulates an app, but for those apps FDA regulates the intended use determines the degree of regulation.

Paraphrasing a bit, FDA regulates any smart phone apps intended for use in the diagnosis or treatment of disease or other conditions. And that intended use is determined mostly by examining the developer’s promotional claims as well as the features of the app.