A definitive guide distinguishing unregulated mobile wellness apps from regulated mobile medical devices under FDA oversight.
The FDA divides mobile health software into three categories: software that is not a medical device (general health/fitness), software for which the FDA exercises enforcement discretion (low risk, such as medication reminders), and software that is subject to mandatory regulatory oversight (high risk).
We examine the specific functionality that transforms an app into a regulated medical device: performing patient-specific medical calculations, analyzing imaging or sensor data for diagnosis, controlling physical medical hardware, or providing active clinical treatment.
How health-tech companies can launch non-clinical wellness features initially under enforcement discretion while preparing clinical modules for formal 510(k) submissions in parallel.