In the past couple of years, as tech companies have increased their interest in digital health and wearables, we've seen a lot of them hit a regulation-based firewall.
That wall is the US Food and Drug Administration, and companies are a little wary of running into the FDA when they put together their health devices.
But why are they wary – and why do companies even need the FDA's approval when they put together their (potentially) life-saving devices? That's what we'll walk you through right here.
What the heck is the FDA?
Established way back in 1906, the FDA is a government body in the US that protects and promotes public health. It does this by making sure that some of the products we use are safe, and that the food we stuff in our mouths is okay to eat.
So yeah, all the drugs and vaccinations you use to keep from getting sick, or to get better, are first checked out by the FDA. The same goes for any food you eat, from Oreos to ice cream. Well, except for livestock, poultry and eggs, which are handled by another government agency.
Those are the two big things the FDA does, and the two things it talks about in its name (food and drugs, get it?), but it also does a lot of other things. It makes sure radiation from electronic devices is at a safe level, for instance. It also makes sure make-up and dietary supplements are good to go.
And finally, it tries to help speed up innovations in health products. Because it already checks out vaccinations and drugs, it checks out medical devices too. So if you've got a medical device that can do certain things, the FDA needs to take a look at it first, or you can't sell it.
How does this approval thing work?
The first step to getting approval is figuring out if you have a device that even needs an approval. Now, a 'device' doesn't even need to have wires or batteries or circuit boards. FDA-approved devices include things like tongue depressors and bed pans.
If your device is listed in the National Formulary or United States Pharmacopoeia (two medical drug lists), intended for use in the diagnosis, prevention, cure or mitigation of disease in either humans or other animals, or intended to affect the structure of either humans or other animals, then it's going to need that FDA stamp of approval.
If you do have a medical device on your hands, there are three classifications that the FDA might assign to it – Class I, II or III – and they're assigned based on the potential risk to the patient or user. Most devices will also need a Premarket Notification approval. This is an application where the person who made the device has to prove that the device is at least as safe and as effective as something already out in the market.
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If you have a Class III device that sustains or supports human life, plays an important part in preventing the harm of human life, or presents an unreasonable risk of patient injury, then you'll need a Premarket Approval. You basically round up your best scientists to prove the safety and effectiveness of your device.
Once that's all submitted, and the FDA gets around to approving it (90 days for Premarket Notification, 180 days for Premarket Approval), you'll get to sell your device on the market – congratulations!
Just know that if you make any changes to features or anything, you'll have to resubmit. That's one reason why big players like Apple, Fitbit and Samsung avoid making their devices too health conscious, and are quick to say they don't diagnose anything. Could you imagine if the new Apple Watch or Fitbit had to sit through a months-long approval process before release?
What kind of wearables are already approved?
The biggest name in FDA-regulated wearables is easily Dexcom, and that's despite Dexcom not even making a wearable. It's purely because Dexcom, which makes devices to monitor glucose for those with diabetes, partners up with companies like Apple and Fitbit to provide them data.
Outside of that, there is KardiaBand from AliveCor. That's the first Apple Watch band approved by the FDA, and it now allows Apple Watch users to track their EKG right from their wrists.
So really, there isn't much out there if you're looking for sleek wearable devices that also sport FDA approval. There are a couple just over the horizon, however. Omron's blood pressure-monitoring smartwatch is looking to release later this year after receiving FDA approval.
Then there's the Biostrap band, which aims to go deeper on biometric information and is looking to gain FDA approval. And of course, Bragi's Project Ears is hoping to tackle tinnitus and enhance hearing, which it's seeking the FDA stamp for.
Will it ever get less complicated?
Yes! The FDA recently announced a new pilot program which includes big wearable players like Apple, Fitbit, Samsung and several other companies. The program would basically let these companies fast track health developments.
For example, the Fitbit Ionic has SpO2 sensors for detecting sleep apnea, but it can't actually roll this feature out until it validates it. Instead of doing the validation and science itself, it can turn to the FDA to help it out.
The companies have to submit a good deal of information to the FDA though, like access to testing information and quality management information in addition to real-world data that's been collected. Once that's collected and approved, the companies won't have to go through the more stringent, and slower, classification processes.
Until now, the lengthy FDA approval process has held back wearable tech companies from trying to get medical-grade technology into consumer devices. But the new fast-track route could change that, guaranteeing a faster approval process and encouraging tech companies to pursue more ambitious ideas.
For all of us, that means we'd get the best health features quicker and, hopefully, safer than ever. It's a win, win, win.
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