The FDA is seeking input on its proposed oversight approach for mobile medical applications (“apps”) designed for use on smartphones and other mobile computing devices. This approach encourages the development of new apps, focuses only on a select group of applications, and will not regulate the sale or general consumer use of smartphones or tablets.
The agency’s draft guidance defines a small subset of mobile medical apps, including those that are used as an accessory to medical devices already regulated by the FDA, or that transform a mobile communications device into a regulated medical device by using attachments, sensors, or other devices.
The FDA will update the guidance based on feedback received. ■