updated 01:31 pm EDT, Mon September 23, 2013
Agency promises enforcement discretion
The US Food and Drug Administration has finalized its guidance for smartphone apps that relate to healthcare. The agency promises to take a "tailored approach" to mobile apps, with no enforcement of Federal Drug & Cosmetic Act regulations for the majority of apps that pose a "minimal risk" to consumers.
Enforcement efforts are said to be focused on a smaller subset of apps that present a greater risk if they fail to function as intended. Regulators will closely scrutinize any apps that will be used as an accessory to a regulated medical device, along with apps that effectively transform a mobile device into a regulated medical device.
The agency gives several examples of apps that must meet strict guidelines, such as apps that turn a phone into an electrocardiography (EEG) machine or allow users to view the output from a glucose meter. Apps that are used by doctors to view medical images for subsequent diagnosis will also be required to comply with existing regulations.
Apps that are submitted the the FDA are said to be assessed using the same standards that are applied to other medical devices, though the agency notes that it does not directly regulate 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 Doctor Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health.
The agency has already approved approximately 100 medical apps in the past ten years, including 40 titles that were submitted in the past two years.