Here’s Why the Blood Oxygen Sensor in Apple Watch Series 6 Didn’t Require FDA Approval

Apple introduced the ECG functionality in Apple Watch with the launch of the Apple Watch Series 4. And to offer this feature in the smartwatch, the brand had to take approval from the FDA. However, Apple didn’t have to take approval from the FDA to offer the blood oxygen monitor in the Apple Watch Series 6, and here is why.

The Cupertino-based tech giant introduced the blood oxygen monitor in its smartwatch lineup with the launch of the Apple Watch Series 6. And considering that Apple had to take approval from the FDA to offer the ECG functionality, anyone would think that the brand had to take approval from the FDA to offer the blood oxygen monitoring feature as well.

As it turns out, that isn’t the case. Apple didn’t have to take approval from the FDA to offer a blood oxygen monitor in the Apple Watch Series 6. And The Verge, in its latest report, explains why the brand didn’t have to take FDA approval to offer this feature.

According to the publication, the blood oxygen monitor is classified as a Class II medical device by the FDA. Any company that wants to sell a blood oxygen monitor needs to submit documents to the health agency proving that their blood oxygen monitor works as good as other versions of the same product that are already on sale.

However, FDA’s policies also say that if a brand markets its blood oxygen monitor as a “wellness” device rather than a device to diagnose or treat any medical condition, it will not have to take any clearance from the health agency to sell the device to the public. And that is the route that Apple took.

While the brand didn’t clearly say that that the blood oxygen sensor in the Apple Watch Series 6 is a “wellness” device, it didn’t market it as a device to diagnose or treat a medical condition either. So, technically, Apple is marketing the blood oxygen monitor in the Apple Watch Series 6 as a “wellness” device, which allowed it to offer the feature to the public without taking approval from the FDA.

So why did Apple take an FDA approval for ECG? Could it not have marketed the ECG feature as a “wellness” device as well? Nope. The ECG functionality that is in the Apple Watch Series 4 is classified as a feature that can diagnose or treat a medical condition, by the FDA; it cannot be classified as a “wellness” device, which is why Apple had to take an approval from the FDA to offer the ECG functionality. But the same wasn’t the case with the blood oxygen monitor and Apple could offer it without an FDA approval.

What we don’t know at the moment is if Apple took the decision to market the blood oxygen monitor in the Apple Watch Series 6 to skip getting approval from the FDA or if the brand truly wants people to see it as a “wellness” device. Whatever the case, the blood oxygen monitor has become the need of the hour; it is an essential device to diagnose the COVID-19 virus. And the fact that Apple Watch Series 6 has this feature, makes it a life-saving device, at least at the moment.

We Want to Hear from You

Have you been using the blood oxygen monitor in the Apple Watch Series 6? If yes, have you found it to be accurate? Do let us know about your thoughts in the comments section below.

[Source: The Verge]