Many of the wearable devices and mobile health apps available to consumers won't be subject to U.S. Food and Drug Administration regulation, according to draft guidelines from the agency.
Devices and software that promote general wellness are, overall, safe to use, the agency said Tuesday. Such devices and applications don't claim to solve specific and chronic medical conditions an thus won't require government oversight, the agency said. Under these guidelines, a majority of wearable devices, including the Apple Watch, set to go on sale in the second quarter, Android Wear smartwatches and fitness trackers such as Fitbits, won't require regulation.
General wellness products foster a healthy lifestyle through fitness and eating. Devices that reduce the risk of or mitigate chronic diseases that are impacted by healthy living also fall under this category. Examples of devices that won't need regulation include those that promote physical fitness by recording exercise, track sleeping patterns to improve sleep management and promote eating habits that help a person maintain a healthy weight. An app claiming to help people maintain a healthy diet to prevent diabetes and high blood pressure would also not be subject to regulation, since healthy eating is known to reduce the risk of developing those ailments.
Devices that make medical claims regarding the treatment of chronic disease and illness would be regulated, however. Such devices would include those that claim to treat obesity, eating disorders and anxiety, among other conditions.
The FDA issued the guidelines, which are subject to a 90-day public comment period, after device makers sought guidance from the agency. They also come as more wearable devices designed to improve health enter the market.
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