FDA Publishes Final Guidance For Mobile Medical Apps

Circle Connections: Policy & Regulatory Updates After more than two years since the FDA first published its draft guidance on how it regulates mobile medical applications, the agency announced it had published its final guidance on the regulation of mobile medical apps. The two broad categories of apps that the FDA regulates, according to the final guidance, are: 1) apps that are intended to be used as an accessory to a regulated medical device – for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication . . .