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Here’s why Apple did not need FDA approval for oxygen measurement from the Apple Watch Series 6



While Apple went to great lengths to obtain regulatory approval for the Apple Watch Series 4’s ECG feature, the company did not do the same for a blood acid monitoring feature on the Apple Watch Series 6. Here’s why.

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

As is usual in the consumer electronics industry, the oxygen function of blood in Series 6 does not have similar certifications. According to The Verge, this is because pulse oximeters, also known as blood oxygen monitors, are in a different FDA classification. As long as a company does not claim that the devices can diagnose diseases, it can sell one in the United States with little supervision.

In general, a company must submit documentation to the FDA confirming that a blood oxygen sensor product works as well as other devices already on the market. But Apple, and other smartwatches and health-focused platforms, took a different route. If a company claims that a pulse oximeter is only used for general “well-being” or just for fun, it does not need to undergo any kind of approval process.

“Apple Watch is already a powerful health tool with apps that measure heart rate and heart rate. And now Blood Oxygen is adding a new valuable health measure to users,” said Apple’s Chief Health Officer Sumbul Ahmad Desai at the time of the device’s release.

The Verge notes that the FDA becomes involved if a health function seeks to influence the medical treatment that a user receives. Apple’s ECG feature falls into this category, as it serves the specific purpose of detecting and alerting users to unusual heartbeats.

In order to even have the ECG cleared, Apple needed to submit documents and data that proved that it could accurately detect a medical condition. It could.

And although Apple and other healthcare partners are currently studying how pulse oximeters can help manage and control diseases, there are currently no firm reports suggesting that it provides accurate information.


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