FDA updates guidance on regulating digital health tools

The Food and Drug Administration last week updated 2017 draft guidance to clarify the categories of clinical and decision support software subject to FDA oversight under the 21st Century Cures Act based on risk, and released final guidance on the types of software no longer considered medical devices under the Act’s amended definition of device. “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,” said Principal Deputy Commissioner Abernethy, M.D. “Such technologies tend to pose a low risk to patients, but can provide great value to consumers and the health care system.”