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FDA Steps Back from ‘Low Risk’ mHealth Regulation

The agency says it won't scrutinize 'low-risk' mHealth devices and apps that promote general health and wellness but don't venture into clinical applications.

By Eric Wicklund

- Federal officials won’t regulate activity trackers and other mHealth devices and apps that focus on “general wellness” – though they may intervene if the products in question touch on clinical applications.

The long-awaited final guidance from the U.S. Food and Drug Administration on low-risk devices follows a first draft released some 18 months ago, and gives the healthcare industry and mHealth developers a clear distinction between commercial and clinical mHealth.

In essence, the FDA said it “does not intend to actively regulate low-risk technologies that are intended only for general wellness use [and] encourages the development of general wellness technologies, such as fitness trackers or mobile apps, which can empower individuals to take a more active role in their health.”

The final rule does not apply, the FDA said, to invasive or implanted products or those that “involve an intervention or technology that may pose a risk to the safety of users and other persons if specific regulatory controls are not applied.”

Reaction was swift and generally positive. Bradley Merrill Thompson, a Washington D.C. attorney with Epstein Becker Green and a noted mHealth expert, praised the final rule for offering details on what it classifies as “low risk” – it eliminated a reference to cardiac function, he said, indicating the FDA wants to keep an eye on devices and apps having to do with the heart.

Morgan Reed, executive director of the ACT | The App Association, told Politico other agencies should use the rule "as a model for regulatory guidance."

"One of the biggest challenges for companies in the wellness space is understanding how and when their technology might run into regulatory scrutiny. This guidance provides the type of clarity we have sought for a long time," he said.

The FDA’s final rule is “exactly right to keep your Fitbit or Weight Watchers app free of unnecessary government oversight and red tape,” Senate health committee chairman Lamar Alexander (R-Tenn.) said. “The recent surge of innovative fitness trackers and mobile health apps is good news for Americans who want to take an active role in monitoring and improving their own health. 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.”

According to the final rule, the FDA is classifying a general wellness device as one that “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.”

That definition, experts say, will likely be tested in the future when the developers of health and wellness products, including wearables and apps, make claims that their product can affect a specific clinical outcome, such as reducing a diabetic’s a1C level or diagnosing or treating obesity, autism, anxiety disorders or other chronic conditions.

In addition, the guidance specifies that devices and apps claiming to improve the health and wellness of someone with a chronic condition “should only be based on references where it is well understood that healthy lifestyle choices may reduce the risk or impact of a chronic disease or medical condition. That is, the claim that the healthy lifestyle choice(s) may play an important role in health outcomes should be generally accepted; such associations are described in peer-reviewed scientific publications or official statements made by healthcare professional organizations.”

Dig Deeper:

FDA’s mHealth Innovation Program Sees Success in its First Year

FDA Urged to Clarify Clinical Decision Support Regulations


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