FDA Issues Guidances for Digital Health Tools

Lifestyle Apps Will Be Officially Free of FDA Regulation

The Food and Drug Administration released a collection new guidances today for digital health tools, including one that will remove many health-related lifestyle smartphone apps from agency oversight.

“We’re making clear that certain digital health technologies–such as mobile apps that are intended only for maintaining or encouraging a healthy lifestyle–generally fall outside the scope of the FDA’s regulation,” says the press release. “Such technologies tend to pose a low risk to patients, but can provide great value to consumers and the health care system.”

One guidance for clinical decision support software, is a revised draft guidance based public comments received on the draft published in 2017..

The press release says the clinical decision support (CDS) guidance is supposed to focus regulatory oversight on CDS functions that are intended to affect clinical management of serious or critical conditions.

“An example of a product we would focus our oversight on would be CDS that identifies hospitalized, type 1 diabetic patients at increased risk of postoperative cardiovascular events and which does not explain why the software made that identification to the health care professional,” says the press release. “In this case, if the CDS provides information that is not accurate (e.g., inappropriately identifies a patient as low risk when he is high risk), then any misidentification could lead to inappropriate treatment and patient harm. Since the potential for patient harm is significant, FDA regulation plays an important role in evaluating the software’s safety and effectiveness.”

The FDA also issued a  final guidance for changes to existing medical software policies resulting from Section 3060 of the 21st Century Cures Act. This final guidance outlines the FDA’s interpretation of the types of software that are no longer considered medical devices under the amended definition of device, according to the press release. It’s this guidance that steers the agency away from regulating apps that encourage people to, for example, eat healthier food or exercise more.

The agency also announced today that it was updating four previously issued FDA final guidances to align with interpretations and policies under the Cures Act: Final Guidance on Policy for Device Software Functions and Mobile Medical ApplicationsFinal Guidance on General Wellness: Policy for Low Risk DevicesFinal Guidance on Off-The-Shelf Software Use in Medical DevicesFinal Guidance on Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices.

Source: FDA, September 26