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

The making of an MSSP: a blueprint for growth in NZ

The making of an MSSP: a blueprint for growth in NZ

Partners are actively building out security practices and services to match, yet remain challenged by a lack of guidance in the market. This exclusive Reseller News Roundtable - in association with Sophos - assessed the making of an MSSP, outlining the blueprint for growth and how partners can differentiate in New Zealand.

The making of an MSSP: a blueprint for growth in NZ
Reseller News Platinum Club celebrates leading partners in 2018

Reseller News Platinum Club celebrates leading partners in 2018

The leading players of the New Zealand channel came together to celebrate a year of achievement at the inaugural Reseller News Platinum Club lunch in Auckland. Following the Reseller News Innovation Awards, Platinum Club provides a platform to showcase the top performing partners and start-ups of the past 12 months, with more than ​​50 organisations in the spotlight.​​​

Reseller News Platinum Club celebrates leading partners in 2018
Meet the top performing HP partners in NZ

Meet the top performing HP partners in NZ

HP has honoured its leading partners in New Zealand during 2018, following 12 months of growth through the local channel. Unveiled during the fourth running of the ceremony in Auckland, the awards recognise and celebrate excellence, growth, consistency and engagement of standout Kiwi partners.

Meet the top performing HP partners in NZ
Show Comments