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The FDA Wants to Regulate Whether Your Smartwatch Can Tell You to Turn Your Head and Cough

I still don’t take the wearable market seriously, but the FDA doesn’t share my skepticism.

Federal regulators are growing concerned that wearables are rapidly morphing from simple gadgets into medical devices, and on Tuesday the FDA issued a draft set of guidelines which try to define when a low risk product which promotes health management crosses into the territory of medical devices.

pebble watch

According to the draft guidelines, a general wellness product (like a wearable) becomes a medical device when it goes beyond the general goals of most wearables – to help people monitor their sleeping patterns, activity levels, food consumption, and medical stats.

Devices that claim any of the following aren’t general wellness devices according to the draft guidance:

  • the  product will treat or diagnose obesity;
  • it will treat eating disorders, such as anorexia;
  • it helps treat anxiety;
  • a computer game that will diagnose or treat autism;
  • a product that will treat muscle atrophy or erectile dysfunction;
  • a product that will restore a structure or function impaired due to a disease, e.g., a claim that a prosthetic device enables amputees to play basketball.

Wearables which are designed to assist with weight, sleep, or stress management, but do not mention a specific condition or disease, will not be affected by the draft guidelines. Fitness wearables that are designed to build muscle mass, improve flexibility or sexual function, or increase aerobic activity are also exempt.

In short, the FDA is bringing the same scrutiny to wearables that food supplements receive. This is going to have all sorts of interesting effects on the marketing claims of some of the wearable makers – not that that is a bad thing.


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puzzled January 21, 2015 um 4:07 am

"?a product that will treat muscle atrophy or erectile dysfunction"

So, the FDA has declared porn to be a medical device?

Nate Hoffelder January 21, 2015 um 7:41 am

Yep. I can’t wait to see the FDA regulate that industry.

fjtorres January 21, 2015 um 8:34 am

Some aspects are.
Especially on the HIV testing side.
Remember, porn is a major contributor to the bottom line at all the giant media companies. Wouldn’t do for lawsuits to pop up naming names and showing where the money goes.

jjj January 21, 2015 um 9:28 am

Actually this is scam, they just let everybody go crazy, just like food supplements don’t get even minimal oversight.
All those health sensors are getting away with their claims no matter if the numbers are wildly inaccurate.
Apple can just display random numbers on the screen and they get away with it as long as they don’t claim to make your penis bigger.
A phone or a bracelet that claims to measure your heart rate , sleep and so on should display accurate results and regulators should enforce that. People keep buying those things but they don’t really have a clue if the data is in any way accurate.
This is corporations making the law and it can actually put lives at risk, when someone relies on that data. Maybe someone should request to see FDA conversations with Samsung and Apple, to w/e degree the freedom of information act covers that.

jjj January 21, 2015 um 9:37 am

Forgot to mention that device makers are actually idiots for not requesting FDA approval for their sensor data . People need to trust those devices and it would help a lot from a marketing point of view. The lack of reliability can only harm this segment.
They are afraid of regulations but if they can dictate the law,they can certainly find a way to an approval process that is painless.

fjtorres January 21, 2015 um 9:50 am

The marketing guys would love to be able to claim FDA approval but if there is one bureaucracy that moves slower than a glacier it is the FDA. By the time they got approval for their product it would be obsolete and their competitors' equivalent products would be selling in blister packs in supermarkets.

All the FDA is going to achieve is that the shrink wrapped TOS for wearables are going to get a few extra paragraphs worth of agate type disclaimers.

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