The Food and Drug Administration has released guidance on low-risk devices intended to promote general wellness, including mobile health and fitness apps.
Under the final guidance, which contains “non-binding” recommendations for the industry, the FDA indicated that it “does not intend to actively regulate low-risk technologies that are intended only for general wellness use” and that the agency “encourages the development of general wellness technologies, such as fitness trackers or mobile apps, which can empower individuals to take a more active role in their health.”
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