When does an app become a device?
Yes, there is a definitive answer—and if you don’t know it, you move ahead with an app at your own peril.
In a nutshell, the FDA considers as a device any app that aims to diagnose, treat, cure or prevent diseases or other conditions. Is your app “intended to affect the structure or any function” of someone’s body? That’s a device too.
None of that means that developing a “non-device” app is smooth sailing, however. Fortunately, C3 has both the Android and iOS experience you need to create a best-of-breed app, and the regulatory knowledge to help you bring it to market.