On Friday, the U.S. Food and Drug Administration (FDA) announced its highly-anticipated decision that they will not regulate fitness trackers and certain mobile health apps. The recently released final guidance is meant to provide technology companies with a better understanding of which products fall under the FDA’s regulatory authority, and which do not.
The FDA said they will not enforce its rules over technologies and apps that are “intended only for general wellness, such as tools for weight management, physical fitness or mental acuity.” The agency further said they encourage “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.”
However, the FDA was quick to add that its policy applies only to general wellness products that are low-risk, and does not apply 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.”
The final guidance confirms that the FDA is taking a “hands-off” approach to the regulation of low-risk general wellness products that only promote a healthy lifestyle or that promote a well-known association between a healthy lifestyle and a certain disease or condition.
“We feel this policy encourages the development of low-risk general wellness technologies, while also protecting the public health,” said Bakul Patel, associate director of digital health in the FDA’s Center for Devices and Radiological Health. “The guidance also clarifies that the FDA will continue to focus its oversight on products that are invasive, implanted or pose greater risks to patients, even if they are intended for general wellness purposes.”