Why Apple Didn’t Need FDA Approval for the Blood Oxygen Tracking Feature in the Apple Watch Series 6
October 8, 2020 | technology | No Comments
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.”