Evolving Regulatory Oversight
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FDA Guidance Adds Clarity to the Regulation of Wearable Medical Devices
Since the proliferation of fitness trackers like the Fibit and mobile health apps, FDA's regulatory guidance has evolved significantly, enabling the space to grow even faster than it already had been. In 2016, for example, FDA announced a policy of enforcement discretion for "general wellness" products, meaning consumer products intended for maintaining or encouraging a healthy lifestyle and that present low risk to users. Earlier this year the agency posted two draft guidance documents that outline FDA's current thinking about low-risk wellness devices, enabling manufacturers to bring these products to market faster and cheaper. Meanwhile, as noted on the previous slide, consumer tech giants like Apple and Fitbit continue to see the value in investing more time and money into their products in order to compete more directly with wearable medical devices like AliveCor's KardiaMobile ECG. Last year, AliveCor secured FDA clearance for its KardiaMobile ECG to detect BradyCardia and TachyCardia.