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.
Let’s focus here on promotional claims. This is where the art comes in. There’s a reason English is taught in liberal arts colleges, and not engineering. Words can be strung together to communicate an endless array of ideas, some of them different only in quite subtle nuances. There is nothing linear about the English language. We can state a concept clearly, or we can state it generally, or we can state it cleverly in ambiguous terms. We can be explicit or we can imply things. Language is an art form.
So if FDA’s jurisdiction is determined by the language we use, and language is an art form with many ways to express closely related but not identical thoughts, how do we know exactly where FDA draws the regulatory line? The most honest answer is we don’t, at least not exactly. There is judgment required.
But that’s not to say that chaos reigns. The system has been working reasonably well for decades because there are ways to discern which intended uses FDA regulates. Keep reading>>