- Creators of wellness-related devices were celebrating Friday as the FDA released its final guidance indicating it would not be regulating low-risk products such as mobile health and fitness apps that aim to promote general wellness.
- The non-binding industry recommendations indicate the FDA will stay hands-off in order to encourage the continued development of technologies that "can empower individuals to take a more active role in their health.”
- The guidance states the FDA will continue to oversee products that are invasive, implanted or otherwise pose a risk to the safety of users or others such as lasers, sunlamps or neurostimulation devices.
The guidance was generally well received for removing unnecessary red tape and clarifying the deal for developers on how to market their wellness products without drawing FDA scrutiny.
Among those who responded were Senate health committee Chairman Lamar Alexander (R-Tenn.) who said it was the right approach.
“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,” Alexander stated.
According to Bradley Merrill Thompson of D.C.-based law firm of Epstein Becker Green, an expert on medical device regulatory issues, the FDA's approach was extremely helpful because it clarified what it means by “low risk” through examples.
“Adding examples is extremely useful because it gives us more data from which we can infer exactly what FDA means,” Thompson told Health Data Management. “Indeed, in several cases, it seems that FDA broadened the examples, but in others narrowed them."