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US regulators plan to relax oversight of health and fitness wearables
2 day ago /
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Author：小编
The U.S. Food and Drug Administration (FDA) announced on Tuesday that it will relax oversight of health lifestyle wearables and related software, and release new guidance documents to clarify the scope of regulation. Building on existing policies, the new rules further clarify that low-risk 'health and wellness' tools such as fitness apps and activity trackers, if used solely to encourage exercise, provide general health information, and do not involve claims of disease diagnosis or treatment, will be regarded as non-medical devices and exempt from stringent oversight.
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