December 20, 2022: We disagree with the guidance because of the enormous loophole it represents. Altering the eligibility criteria for the breakthrough pathway to include certain devices that have the “potential” to benefit certain populations is too vague. FDA must Improve the standards of evidence required to authorize Breakthrough medical devices prior to focusing on equity issues.
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Wearable Health Devices and Personal Health Trackers: What You Need to Know
Wearable medical devices such as the FitBit or other SmartWatches are electronic devices that you wear to track personal health data, such as how many steps you have taken today or your heart rate. We explain how wearable devices are regulated, are they accurate, and what are the risks of relying on them?
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