Menu
Many wearable devices won't require FDA regulation

Many wearable devices won't require FDA regulation

The agency will require registation only of devices that make claims of treating medical conditions

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.

Fred O'Connor writes about IT careers and health IT for The IDG News Service. Follow Fred on Twitter at @fredjoconnor. Fred's e-mail address is fred_o'connor@idg.com


Follow Us

Join the newsletter!

Or

Sign up to gain exclusive access to email subscriptions, event invitations, competitions, giveaways, and much more.

Membership is free, and your security and privacy remain protected. View our privacy policy before signing up.

Error: Please check your email address.

Tags governmentregulationconsumer electronicsU.S. Food and Drug Administration

Featured

Slideshows

Reseller News launches new-look Awards at 2018 Judges’ Lunch

Reseller News launches new-look Awards at 2018 Judges’ Lunch

Introducing the Reseller News Innovation Awards, launched to the channel at the 2018 Judges’ Lunch in Auckland. With more than 70 judges now part of the voting panel, the new-look awards will reflect the changing dynamics of the channel, recognising excellence across customer value and innovation - spanning start-ups, partners, distributors and vendors.

Reseller News launches new-look Awards at 2018 Judges’ Lunch
Kiwi channel debates GDPR as Reseller News Exchange hits Wellington

Kiwi channel debates GDPR as Reseller News Exchange hits Wellington

This exclusive Reseller News Exchange, in association with Arrow ECS ANZ, ForeScout and StorageCraft, went on the road to debate the early implications of GDPR in New Zealand, extracting opportunities while evaluating challenges for the channel in the year ahead.

Kiwi channel debates GDPR as Reseller News Exchange hits Wellington
Show Comments