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.”
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