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 6
Buyer's Guide: Apple Watch (Neutral)

Top Rated Comments

Apple_Robert Avatar
20 weeks 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)
terraphantm Avatar
20 weeks 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: 13 Votes (Like | Disagree)
randolorian Avatar
20 weeks 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
20 weeks 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
20 weeks 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
20 weeks 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)

Top Stories

jon prosser imac 2021colors

Prosser: 2021 iMac to Come in Five Colors, Apple Silicon Mac Pro to Resemble 'Stacked' Mac Minis

Wednesday February 24, 2021 7:26 am PST by
Hit-and-miss leaker Jon Prosser has today alleged that the upcoming 2021 iMac models will offer five color options, mirroring the colors of the fourth-generation iPad Air, and revealed a number of additional details about the Mac Pro with Apple Silicon. In a new video on YouTube channel FrontPageTech, Prosser explained that the redesigned iMacs will come featuring options for Silver, Space ...
2021 mbp sd slot feature2

Kuo: New MacBook Pro Models With HDMI Port and SD Card Reader to Launch Later This Year

Monday February 22, 2021 8:52 pm PST by
Apple plans to release two new MacBook Pro models equipped with an HDMI port and SD card reader in the second half of 2021, according to analyst Ming-Chi Kuo, who outlined his expectations in a research note obtained by MacRumors. The return of an SD card reader was first reported by Bloomberg's Mark Gurman last month. "We predict that Apple's two new MacBook Pro models in 2H21 will have...
m1 mac mini

M1 Mac Users Report Excessive SSD Wear

Tuesday February 23, 2021 7:07 am PST by
Over the past week, some M1 Mac users have been reporting alarming SSD health readings, suggesting that these devices are writing extraordinary amounts of data to their drives (via iMore). Across Twitter and the MacRumors forums, users are reporting that M1 Macs are experiencing extremely high drive writes over a short space of time. In what appear to be the most severe cases, M1 Macs are sai...
iphone 12 pro display video

BOE Rumored to Supply iPhone 13 Display Panels After iPhone 12 Failures

Monday February 22, 2021 9:54 am PST by
Display manufacturer BOE will be one of the main suppliers of OLED panels for iPhone 13 models, according to a new report today from Taiwan's Economic Daily News. BOE is said to be working with touch panel manufacturer General Interface Solution (GIS), part of the Hon Hai Group to develop OLED panels. Multiple iPhone 12 rumors suggested that BOE would supply some panels for the devices,...
flat mbp 14 inch feature yellow

Redesigned 14-Inch MacBook Pro Expected to Feature Brighter Mini-LED Display With Slimmer Bezels and More

Thursday February 25, 2021 7:48 am PST by
Apple plans to unveil new 14-inch and 16-inch MacBook Pro models with Mini-LED-backlit displays in the second half of this year, according to industry sources cited by Taiwanese supply chain publication DigiTimes. The report claims that Radiant Opto-Electronics will be the exclusive supplier of the Mini-LED backlight units, while Quanta Computer is said to be tasked with final assembly of the...
anker magsafe powercore battery pack

Anker Releases MagSafe-Compatible Battery Pack for iPhone 12 Lineup

Tuesday February 23, 2021 7:49 am PST by
Following rumors that Apple is working on a MagSafe battery pack for iPhone 12 models, popular accessory maker Anker has beaten Apple to the punch with the release of its PowerCore Magnetic 5K Wireless Power Bank. First previewed at CES 2021, the PowerCore battery pack magnetically attaches to the back of any iPhone 12 model and provides 5W of wireless charging. With a 5,000 mAh capacity,...
iPad Pro Mini LED

New iPad Pro and MacBook Models With Mini-LED Displays Again Rumored to Launch This Year

Monday February 22, 2021 9:32 pm PST by
Taiwanese company Ennostar will begin production of Mini-LED backlight units for an upcoming 12.9-inch iPad Pro in the late first quarter or second quarter of this year, according to industry sources cited by DigiTimes. Ennostar is a holding company that was jointly established in January 2021 by LED-related manufacturers Epistar and Lextar Electronics. Apple is expected to unveil the new ...
First Look Big Sur Feature2

Apple Releases macOS Big Sur 11.2.2 to Prevent MacBooks From Being Damaged by Third-Party Non-Compliant Docks

Thursday February 25, 2021 10:07 am PST by
Apple today released macOS Big Sur 11.2.2, the fourth update to the macOS Big Sur operating system that launched in November. macOS Big Sur 11.2.2 comes two weeks after the release of macOS Big Sur 11.2.1, a bug fix update. The new ‌‌‌‌macOS Big Sur‌‌‌ 11.2.2‌ update can be downloaded for free on all eligible Macs using the Software Update section of System Preferences....
steam apple logo

Valve Ordered to Give Apple Information on 436 Steam Games As Part of Epic Games Legal Case

Thursday February 25, 2021 1:50 am PST by
Valve, the makers behind popular game distribution platform Steam, will be forced to hand over aggregate historical sales, price, and other information on 436 games hosted on the store to Apple, as part of the Apple vs. Epic Games antitrust case. As reported in a paywalled report by Law360, during a virtual discovery hearing on Wednesday, U.S. Magistrate Judge Thomas S. Hixson ordered that...
scott forstall original iphone

Epic Games 'Attempting to Locate' Former iOS Chief Scott Forstall to Testify in Ongoing Legal Battle with Apple

Tuesday February 23, 2021 4:22 am PST by
As part of its ongoing legal battle, Epic Games is now seeking testimony from Apple's former iOS software chief, Scott Forstall. Forstall left Apple in 2013, in what was widely reported at the time to have been a forced exit, largely because of the botched early launch of Apple Maps. Since then, Forstall has kept a very low profile and has only made a few media appearances in the past few...