While Apple needed to obtain U.S. FDA approval for the ECG functionality it debuted in the Apple Watch Series 4, it didn’t need such approval for its Blood Oxygen monitoring feature in its recent Apple Watch Series 6, as it isn’t seen as a medical feature.
As reported by The Verge, pulse oximeters like the blood oxygen tracking feature in the Apple Watch are considered Class II Medical devices and while documentation is generally required, but there’s a way around that. If the feature is being marketed for general wellness or fun instead of being included for a medical purpose, no FDA documentation is needed.
This is why the blood oxygen tracking feature is not being marketed by Apple as a medical feature, and an Apple Support document states that blood oxygen tracking measurements are “not intended for medical use” and are designed for “general fitness and wellness purposes.”
The Apple Watch Series 6 Blood Oxygen app doesn’t provide any insight or analysis of blood oxygen readings and the feature does not send alerts when a lower than normal blood oxygen level is detected, as that would be considered a medical feature.
While Apple’s ECG Apple Watch feature availability is still limited because it requires medical approval in every country it launches in, the blood oxygen feature is currently available in over 100 countries, as it doesn’t require such approval.
