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FDA announces regulatory exemptions for ‘non-medical grade’ devices
FDA commissioner Marty Makary revealed at the 2026 CES trade show in Las Vegas that low-risk devices will face less ...
The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices.
FDA’s decision to limit regulations of non-medical grade wearables marks a notable shift toward regulatory restraint in digital health. FDA announced its plan to stop subjecting non-medical grade ...
The U.S. Food and Drug Administration said on Tuesday that it will limit regulation of wearable devices and software designed ...
These technologies are improving all the time. If they’re not making claims that they are medical grade, let’s let the market ...
FDA announces wearable devices providing non-medical info won't face regulation, offering clarity on digital health ...
FDA nonmedical wearable health data devices providing general health info will not face regulation, clarifying guidance for ...
The Food and Drug Administration today released two guidance documents; one related to low-risk wellness products (including ...
On July 14, 2025, FDA issued a warning letter to WHOOP, Inc., notifying the company that its marketing of Blood Pressure Insights (BPI) was neither cleared nor approved. FDA stated that BPI qualifies ...
One day this summer, Pat McAfee, the former NFL punter turned ESPN personality, interviewed New York Jets cornerback Sauce Gardner about his partnership with Q-Collar, the only medical device cleared ...
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