The US Food and Drug Administration (FDA) published the final, and long awaited, guidelines on how it intends to regulate health and wellness apps.
The objective of the guidelines is to provide more clarity to developers about the types of apps that will fall under FDA regulation.
The agency has been under pressure for some time to publish – the initial, draft guidelines were published more than two years ago.
In the end, the agency’s position will cause few surprises. In fact, only a minority of health or wellness apps will fall under its remit.
The FDA says it will focus on two types of apps. The first are those apps that are intended to be used as an accessory to a regulated medical device, for example an application that allows a healthcare professional to make a diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet.
The second type of app transforms a mobile platform into a regulated medical device, for example an app that turns a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.
Mobile health apps that undergo FDA review will be assessed under the same standards that the agency applies to other medical devices.
The FDA also made clear that it does not regulate the sale or general consumer use of smartphones or tablets, or app distributors such as the iTunes App store or Google Play store.
“We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly,” said Jeffrey Shuren (pictured), director of the FDA’s Center for Devices and Radiological Health.