Here’s why Apple didn’t need FDA clearance for Apple Watch Series 6 blood oxygen sensing

While Apple went to great lengths to garner government approval for Apple Watch Series 4’s ECG feature, the company didn’t do the same for a blood oxygen monitoring function on Apple Watch Series 6. Here’s why.

When the ECG feature was introduced on the Apple Watch Series 4, Apple made note that it navigated a lengthy approval process to gain clearance from the Food and Drug Administration.

As is typical in the consumer electronics industry, the blood oxygen feature on the Series 6 doesn’t have similar certifications. According to The Verge, that’s because pulse oximeters, also known as blood oxygen monitors, are in a different FDA classification. As long as a company doesn’t claim that the devices can diagnose diseases, it can sell one in the U.S. with little oversight.

Generally, a company has to submit documentation to the FDA confirming the a blood oxygen sensing product works as well as other devices already on the market. But Apple, and other smartwatches and health-focused platforms, took another route. If a company claims a pulse oximeter is only used for general “wellness” or just for fun, it doesn’t need to go through any type of approval process.

“Apple Watch is already a powerful health tool with apps that measure heart rate and heart rhythm. And now adding blood oxygen brings in another valuable health measurement to users,” said Apple health chief Sumbul Ahmad Desai at the time of the device’s release.

The Verge notes that the FDA does get involved if a health feature seeks to influence the medical care that a user gets. Apple’s ECG feature falls into this category, since it serves the specific purpose of detecting and alerting users to unusual heart rhythms.

To even get the ECG cleared, Apple needed to submit documents and data

Why Apple Didn’t Need FDA Approval for the Blood Oxygen Tracking Feature in the Apple Watch Series 6

Prior to releasing ECG functionality in the Apple Watch Series 4, Apple needed FDA approval for the feature, but the same isn’t true of Blood Oxygen monitoring in the Apple Watch Series 6 because Apple doesn’t see it as a medical feature.


As outlined by The Verge, pulse oximeters like the blood oxygen tracking feature in the Apple Watch are considered Class II Medical devices and documentation is generally required, but there’s a way around that. If a pulse oximeter is marketed as being for general wellness or fun rather than for a medical purpose, FDA documentation is not required.

That’s the reason why the blood oxygen tracking feature is not being marketed by Apple as a medical feature, and an Apple Support document clearly states that measurements taken using blood oxygen tracking are “not intended for medical use” and are designed for “general fitness and wellness purposes.”

The ‌Apple Watch Series 6‌ Blood Oxygen app provides no insight into blood oxygen readings, nor does it send alerts when a lower than normal blood oxygen level is detected, because that would be a medical feature.

Apple is prohibited from using the blood oxygen tracking feature from impacting the medical care that someone receives, which is a deviation from how the ECG functionality works. ECG readings from the watch are used to alert users of an abnormal heart rhythm (atrial fibrillation) and thus required greater oversight. Apple was required to provide the FDA with data proving that the feature can detect atrial fibrillation, which could be examined by experts.

Avoiding regulatory approval in the United States and in other countries permitted Apple to launch the blood oxygen feature in more than 100 countries. ECG availability is still limited because it requires medical approval in each country it launches in.


Michael