FDA taking hands-off policy towards ‘low-risk’ health apps, devices

Fitness trackers and mobile apps that focus on “general wellness” won’t be regulated by the Food and Drug Administration (FDA), according to new guidance released by the agency, while warning that more invasive technologies still fall under its purview.

The non-binding guidance drew a clear line between commercial and clinical mobile health technologies, saying if a “general wellness product” is only intended for that use and presents a low risk to users and other persons, then the FDA “does not intend to examine” those devices.

“A general wellness product, for the purposes of this guidance, has (1) an intended use that relates to maintaining or encouraging a general state of health or a healthy activity, or (2) an intended use that relates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition,” the guidance said.

Products that fall under this definition are apps and devices which involve claims about sustaining or offering information about topics like weight management, sleep management, or sexual function without making specific references to diseases and conditions. The guidance would seem to include popular devices like Fitbit fitness trackers or the Sleep Cycle mobile app.

However, the FDA guidance also said that any product which is invasive, implantable, or “involves an intervention or technology that may pose a risk to the safety of users,” like using lasers or radiation exposure, doesn’t meet the definition of “low risk,” and therefore wouldn’t be included in this hands-off policy.

Reaction to the guidance was largely positive from members of Congress. The chairman of the Senate’s health committee, Sen. Lamar Alexander, R-Tennessee, said in a statement “I’m glad to see that the FDA recognizes this and has no current plans to put unnecessary government red tape between people hoping to use a Fitbit to help them get moving or a Weight Watchers application to monitor their diet.”