As the popularity and adoption of mobile health apps continue to grow, FDA has been working to clarify which apps are considered medical devices and how the agency plans to regulate software apps that are used on a mobile platform. Early this year FDA released a mobile medical applications guidance document.

For developers of mobile medical applications (MMA), FDA provides a variety of resources, including information on how it will exercise enforcement discretion for apps that “may” meet the definition of a medical device and examples of the MMAs cleared by FDA during the past 18 years, from the earliest digital recorders to the smartphone- and tablet-compatible AliveCor Heart Monitor.