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Why the FDA won’t regulate the Apple Watch to death

Published Mar 30th, 2015 6:25PM EDT
Apple Watch FDA

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Back when the Apple Watch was nothing more than a rumor, there was an endless stream of stories focusing on all of the biomedical engineering talent Apple was bringing on board. Consequently, we started to see an influx of reports detailing all of the incredible ways in which the Apple Watch was going to revolutionize personal health. Some reports event went so far as to proffer that Apple’s new wearable might be able to detect impending heart attacks or even measure metrics such as glucose levels.

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Of course, the deeper Apple delves into personal health, the more likely it is that the device will have to pass FDA muster. As it stands now, though, the health-oriented features of the Apple Watch are rather simple. It can measure your heart rate, count your calories, and track your steps. All in all, the Apple Watch is partly designed to help user’s live a healthier lifestyle.

Which is exactly why the FDA thus far hasn’t taken it upon themselves to put the Apple Watch under much, if any scrutiny.

Speaking to Bloomberg, Bakul Patel of the FDA explained the regulatory agency’s mindset.

“We are taking a very light touch, an almost hands-off approach,” Patel said. “If you have technology that’s going to motivate a person to stay healthy, that’s not something we want to be engaged in.”

While that stance might change in the future, assuming the Apple Watch takes on more advanced health-oriented capabilities, it’s nice to see the FDA taking a level headed and measured approach to the burgeoning wearables category.

It’s also worth noting that Apple executives have met with FDA officials a few times over the past few months. More than likely, these meetings were designed to ensure that the Apple Watch’s functionality wouldn’t raise any red flags over at the FDA.

Yoni Heisler Contributing Writer

Yoni Heisler has been writing about Apple and the tech industry at large with over 15 years of experience. A life long expert Mac user and Apple expert, his writing has appeared in Edible Apple, Network World, MacLife, Macworld UK, and TUAW.

When not analyzing the latest happenings with Apple, Yoni enjoys catching Improv shows in Chicago, playing soccer, and cultivating new TV show addictions.