The Food and Drug Administration (FDA) released a final guide last Monday on how mobile medical and health applications (apps) would be regulated.
The FDA determined that the majority of apps pose minimal risk to consumers and thus the agency will not enforce requirements under the Federal Drug and Cosmetic Act. However, the subset of apps that poses greater risk if they do not work as intended will be subject to greater oversight.
"The FDA’s tailored policy protects patients while encouraging innovation," said Director of the FDA’s Center for Devices and Radiological Health Jeffrey Shuren, M.D., J.D., in an FDA press release.
Apps that turn a mobile device into a regulated medical device, such as an app that can turn a smartphone into a electrocardiography (ECG) machine to detect abnormal heart rhythms, will be more closely scrutinized by the FDA.
"It’s not about the platform. It’s about the functionality," Shuren told Reuters. "An ECG is an ECG."
Also subject to close oversight will be apps that are intended to be used as an accessory to already regulated medical devices, such as allowing a medical practitioner to view a medical image from a picture archiving and communication system (PACS) on a mobile device.
The FDA will not be regulating the sale of the apps on online markets like the iTunes App Store or the Google Play Store; nor will it regulate low risk personal wellness apps like calorie counters or pedometers.
