FDA will not regulate fitness trackers, wellness apps

The FDA issued a final guidance on Friday stating it will not regulate low-risk general wellness products that promote a healthy lifestyle.

The guidance document, which was originally issued as a draft in 2015, clarifies the difference between medical devices and wellness products.

The agency defines general wellness products as any product intended for general wellness use that presents a low safety risk. Products include sleep monitors, personal fitness trackers and mobile fitness or health apps.

The document does not establish legally enforceable regulations for wellness products, but does include recommended best practices for how to correctly categorize and market the products.

The FDA will continue to monitor products that are invasive, implanted into the user or pose any type of safety risk to the user or other individuals.

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