FDA Eases Regulation on Wearable Devices In Hopes Of Promoting Innovation
Fox Business
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Contributed by: Kate Gamble
Summary
The FDA has altered its regulatory stance on wearable health devices, announcing that only those claiming to provide medical-grade data will be subject to oversight. This policy shift allows non-medical-grade devices to operate without regulatory constraints, aiming to stimulate innovation in digital health technologies. FDA Commissioner Dr. Marty Makary emphasized the importance of preventing consumer reliance on unvalidated health data while encouraging a competitive market that enables physicians and patients to select effective tools. This change signifies a balancing act between fostering technological advancement and ensuring patient safety within the evolving landscape of healthcare technology.
