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.

1blood oxygen app
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.

bloodoxygenprocess
Michael Matheny, co-director of the Center for Improving the Public's Health through Informatics at Vanderbilt University, told The Verge that when he went to find data on how well the pulse oximeter in the Apple Watch works, there wasn't much out there. "It was concerning to me," he said.

It's also potentially confusing to customers because Apple's marketing is sometimes unclear. "Patients and consumers don't really understand the difference," said Matheny. "So they'll start using the device and relying on the information."

There have been multiple reports from Apple Watch Series 6 owners suggesting the blood oxygen tracking feature isn't particularly accurate when compared to a finger worn pulse oximeter, with successive readings that can be all over the place.

We here at MacRumors have also noticed problems with unusual readings that don't seem to be right and that are suggestive of breathing problems when there are none, which is potentially problematic and could lead to panic over nothing. The feature can also be hard to use, requiring little arm movement with results potentially impacted by cold weather, tattoos, and other factors. Some users have no problem, though, and all Apple Watch Series 6 owners should remember that blood oxygen tracking isn't a medical feature and should not be relied on as a measurement of health, even if it may have some utility as an alert in an emergency situation.

Related Roundup: Apple Watch Series 9
Buyer's Guide: Apple Watch (Neutral)

Top Rated Comments

terraphantm Avatar
46 months ago

The ECG app doesn't diagnose heart attacks, per all the warnings that show up when you start using it. But the health apps, and the information they provide, are a good way to keep track of your personal "normal" and get a warning if something begins to go haywire.
The ECG physically can't diagnose heart attacks because you're not getting a full picture. Take a look at this 12-lead of a STEMI



This guy is having an anterior and probably inferior STEMI based on leads V1-V5 as well is II/III/AVF. But lead I, which is equivalent to the lead your Apple watch checks, is pretty much normal. The Apple watch would have totally missed it, which is why they warn you every time that it cannot diagnose a heart attack.

It is useful for detecting afib, since that shows up in all leads. And it could probably also be useful for detecting things like heart block or QT prolongation and various other arrhythmias, but Apple decided to focus on afib.
Score: 14 Votes (Like | Disagree)
Apple_Robert Avatar
46 months ago
Apple was smart to do this. Maybe down the line they will see FDA approval.

I compared my watch pulse ox to a medical fda proved device yesterday, and each time, there was only a 1% differential between the watch and the device.
Score: 14 Votes (Like | Disagree)
randolorian Avatar
46 months ago
The worst part of reading an article about Apple Watch is being subjected to the unflattering close-up photos of peoples' hairy arms. ;-).
Score: 12 Votes (Like | Disagree)
derTeHa Avatar
46 months ago
Prior to releasing ECG functionality in the Apple Watch Series 5
ECG was available since Apple Watch Series 4.
Score: 12 Votes (Like | Disagree)
JRobinsonJr Avatar
46 months ago
It doesn't have to be 100% accurate, but absolutely should/must be consistent. Doesn't matter what my 'normal' is as long as I can trust the deviation number. Sounds like the Watch version is neither accurate NOR consistent. So... why bother?
Score: 10 Votes (Like | Disagree)
Killbill2 Avatar
46 months ago
Mine has been accurate, 1% variability plus it tracks at intervals through out the day without me walking around with a big ass hunk of electronics on my finger tip. I used my Masimo ($200-$300) not a $20 amazon meter, the watch seems to be very stable when using manual measures. I'd have to leave the Masimo on and pull the data from both to do a comparison on the auto measurements... but I'm feeling lazy maybe another day I'll do that another day.

Attachment Image
Score: 9 Votes (Like | Disagree)

Popular Stories

iOS 18 Siri Integrated Feature

iOS 18 Will Add These New Features to Your iPhone

Friday April 12, 2024 11:11 am PDT by
iOS 18 is expected to be the "biggest" update in the iPhone's history. Below, we recap rumored features and changes for the iPhone. iOS 18 is rumored to include new generative AI features for Siri and many apps, and Apple plans to add RCS support to the Messages app for an improved texting experience between iPhones and Android devices. The update is also expected to introduce a more...
iGBA Feature

Game Boy Emulator for iPhone Now Available in App Store Following Rule Change [Removed]

Sunday April 14, 2024 8:06 am PDT by
A week after Apple updated its App Review Guidelines to permit retro game console emulators, a Game Boy emulator for the iPhone called iGBA has appeared in the App Store worldwide. The emulator is already one of the top free apps on the App Store charts. It was not entirely clear if Apple would allow emulators to work with all and any games, but iGBA is able to load any Game Boy ROMs that...
iGBA Feature

Apple Removes Game Boy Emulator iGBA From App Store Due to Spam and Copyright Violations

Sunday April 14, 2024 9:22 pm PDT by
Apple today said it removed Game Boy emulator iGBA from the App Store for violating the company's App Review Guidelines related to spam (section 4.3) and copyright (section 5.2), but it did not provide any specific details. iGBA was a copycat version of developer Riley Testut's open-source GBA4iOS app. The emulator rose to the top of the App Store charts following its release this weekend,...
iOS NES Emulator Bimmy Feature

NES Emulator for iPhone and iPad Now Available on App Store [Removed]

Tuesday April 16, 2024 11:33 am PDT by
The first approved Nintendo Entertainment System (NES) emulator for the iPhone and iPad was made available on the App Store today following Apple's rule change. The emulator is called Bimmy, and it was developed by Tom Salvo. On the App Store, Bimmy is described as a tool for testing and playing public domain/"homebrew" games created for the NES, but the app allows you to load ROMs for any...
iOS 18 Siri Integrated Feature

Apple's First AI Features in iOS 18 Reportedly Won't Use Cloud Servers

Sunday April 14, 2024 9:52 am PDT by
Apple's first set of new AI features planned for iOS 18 will not rely on cloud servers at all, according to Bloomberg's Mark Gurman. "As the world awaits Apple's big AI unveiling on June 10, it looks like the initial wave of features will work entirely on device," said Gurman, in the Q&A section of his Power On newsletter today. "That means there's no cloud processing component to the...
new best buy blue

Best Buy Opens Up Sitewide Sale With Record Low Prices on M3 MacBook Air, iPad, and Much More

Saturday April 13, 2024 7:41 am PDT by
Best Buy this weekend has a big sale on Apple MacBooks and iPads, including new all-time low prices on the M3 MacBook Air, alongside the best prices we've ever seen on MacBook Pro, iPad, and more. Some of these deals require a My Best Buy Plus or My Best Buy Total membership, which start at $49.99/year. In addition to exclusive access to select discounts, you'll get free 2-day shipping, an...
m3 mbp space black

M4 Macs Are Expected to Launch in This Order Starting Later This Year

Sunday April 14, 2024 10:40 am PDT by
Bloomberg's Mark Gurman recently reported that the first Macs with M4 series chips will be released later this year, with more models to follow next year. In his Power On newsletter today, Gurman shared a more specific roadmap for these Macs. Here is the order in which Gurman expects the Macs to launch:1. A low-end 14-inch MacBook Pro with the M4, coming around the end of 2024. 2. A 24-inch ...
top stories 13apr2024

Top Stories: M4 Mac Roadmap Leaked, New iPads in Second Week of May, and More

Saturday April 13, 2024 6:00 am PDT by
Apple's hardware roadmap was in the news this week, with things hopefully firming up for a launch of updated iPad Pro and iPad Air models next month while we look ahead to the other iPad models and a full lineup of M4-based Macs arriving starting later this year. We also heard some fresh rumors about iOS 18, due to be unveiled at WWDC in a couple of months, while we took a look at how things ...