FDA will not regulate fitness trackers and mobile health applications intended to promote general wellness, according to final guidance released last month.
The guidance clarifies how mobile app and device makers can market their products without being subject to FDA oversight. According to Bloomberg, the final guidance is largely similar to a draft version FDA released in January 2015.
Final guidance details
FDA in the final guidance said it "does not intend to examine low-risk general wellness products," which include certain apps, software programs, video games, and wearable technology.
According to FDA, the general distinction between a general wellness product and a medical device is whether the product makes a medical claim.
FDA said a product can be considered a general wellness item if it is marketed as improving a person's "general state of health"—such as physical fitness, stress management, and weight management—instead of referencing a specific disease or condition. Products that do reference a specific disease or condition will still be considered a general wellness product if they do so in relation to a lifestyle choice intended to prevent or help an individual "liv[e] well with" their illness.
FDA would not consider a product to be a low risk general wellness device if it meets just one of the below criteria:
- Is invasive;
- Poses a threat to user safety if device controls are not in place;
- Raises questions of biocompatibility; or
- Raises novel questions of usability.
In addition, FDA said devices or apps that claim to treat or diagnose a condition do not qualify as general wellness products under the guidance.
Reaction to the final guidance has been largely positive, Politico's "Morning eHealth" reports.
Morgan Reed, executive director of the ACT | The App Association, said, "One of the biggest challenges for companies in the wellness space is understanding how and when their technology might run into regulatory scrutiny," adding, "This guidance provides the type of clarity we have sought for a long time."
Bradley Merrill Thompson—an attorney with Epstein, Becker, & Green—said the guidance "strikes the right balance between regulation and innovation."
Senate Health, Education, Labor, and Pensions Committee Chair Lamar Alexander (R-Tenn.) also praised the guidance for not placing "unnecessary government red tape" on technologies Americans use to improve their health, such as Fitbits (Wicklund, mHealth Intelligence, 7/29; Tyler, National Law Review, 8/15; Pittman, "Morning eHealth," Politico, 7/29; Ruoff, Bloomberg BNA, 7/28; Dvorak, FierceHealthcare, 7/29).
From FitBit to Apple Watch: More about the Internet of Things in health care
As more and more devices in the world become increasingly electronic, software-enabled, intelligent, wireless, and connected, it is worth exploring how the Internet of Things—the connectivity and interoperability of increasingly smart objects, such as appliances, sensors, controllers, wearables, and medical devices—can be leveraged in health care and health IT.