The Food and Drug Administration decided late last week that it would not seek to regulate fitness trackers and wellness mobile apps, freeing the industry from rules that could potentially slow progress in the field.
The FDA released its stance through a guidance document titled, “General Wellness: Policy for Low Risk Devices Guidance for Industry and Food and Drug Administration Staff,” which also makes it clear that all recommendations are nonbinding. Instead, the guidance “describe[s] the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.”
The recommendation covers products intended only for general wellness, according to Bloomberg BNA, including tools for weight management, physical fitness or mental acuity. The FDA document also states that the guidance does not apply to products that refer to specific diseases or conditions, or products that say they can be used to treat or diagnose a disease or disorder.
Making the distinction between healthcare and wellness products is important for the FDA and for industry participants, Bloomberg BNA said. This is because developers “want to be able to market their products as helpful to people with certain medical conditions but want to steer clear of FDA regulations, which can be time-consuming and expensive.
“Products regulated by the FDA must register with the agency, undergo review before they’re sold, and meet certain requirements,” according to Bloomberg BNA.
It’s clear that the FDA is referring to very low-level fitness trackers and apps in its document, ones that consumers wouldn’t mistake for “fix all” health solutions.
Using illustrative examples, the FDA document describes six products that would fall under the “don’t regulate” recommendation, including fitness bands, meditation apps, diet tracking apps, skin exfoliation products, and more.
Sen. Lamar Alexander (R-Tenn), chairman of the Senate Health, Education, Labor, and Pensions Committee, told Bloomberg BNA that he was happy to see the FDA’s recommendation and that it “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.”
Related Posts
We review a lot of health wearables. This one tracks something most ignore.
We've discussed the Hume Band’s design ethos before; specifically, how its screen-free, fabric-wrapped profile respects your attention span. But for those who treat their health as a long-term asset, the form factor is secondary to the data.
Rokid’s AI glasses offer a more affordable route to wearables than Meta Ray-Ban
The AI Glasses Style is completely screenless and weighs just 38.5 grams, making it light enough to wear all day without discomfort. Instead of visual overlays, it relies on voice, audio, and a built-in 12MP Sony camera capable of shooting 4K video in clips up to 10 minutes.
Forget the watch, Apple’s AI Pin might be its next wearable move
According to the details shared so far, the wearable is still in the very early stages of development. In fact, Apple could launch it or even cancel it, depending on how engineering and market conditions evolve. That said, people familiar with the project say the company is targeting a 2027 release window, a move that would position Apple directly against other AI wearable efforts from competitors like OpenAI and others experimenting with similar form factors.