My Email to FDA

[The_Chief]

Please fast-track approval for consumer smartwaches to monitor & track blood pressure.

As an American citizen and patient/consumer with hypertension, I am very conscientious of my blood pressure readings. I have a cuff that is connected with my Samsung Galaxy Health app to track my trends.

Many modern smart watches, like Apple Watch or Samsung Galaxy Watch, have advanced features to track body composition, sleep, ECG and heart rate. Manufacturerers have applied for FDA approval to monitor blood pressure - but have not received approval.

Wearing a watch that monitors my blood pressure, all day every day in real time, would give people like me a far more accurate picture of my overall hypertension trends.

Even if FDA mandates a disclaimer that the watch is not a medically-approved device, an abnormal reading would at least alert users to use an FDA-approved blood pressure cuff to verify it.

I look forward to hearing about FDA approval; and manufacturers being able to activate a health feature that, in many cases, is already in the watch but not yet available for use.

[user9ZoJOdawUv]

The FDA's advice, and probably their methodology, is sound for most cases. The ethics of using police powers to prohibit an ostensibly free people from purchasing it anyway, are not.

[userpMgFwKaOxb]

Well, would it be ethical to just approve a device as a medical device for the "heck of it" because free people are free to make their own decisions? Well in that case free people should install the work around and knock themselves out. Don't get me wrong, I think Samsungs solution should be good enough, but there are standards for medical devices. I have a heart condition that the convenience of using my Watch7 would be a great boon for me. But, I also want it to be reliable if I use it as a medical device. Otherwise, I can use one of the myriad Chinese knockoff sorta-smartwatches that "measure" BP. I've had every iterations of these Sammy smartwatches and have patiently waited for THE watch, but I'm not going to just settle at this point. I just read some newer posts in this thread and was somewhat surprised to read one that suggests that Samsung may never have submitted it's watches to the FDA for approval. If so that would be a bit disingenuous, particularly as the Watch Active leveraged BP as a purchase incentive. I thought the software fell short. If they never submitted their watches for FDA review of the BP feature in the first place, that would be a very certain way to not get FDA approval for the BP feature. This is sort of a what the heck moment in that regard. Six or seven years ago BP was a feature that was being pushed and about 3 years ago it drifted off into obscurity.

[userZRSCLYzCJC]

As customers, all we are asking to get the Blood Pressure Monitor enabled by Samsung as they have done for customers in Canada and other regions.
Whatever the reason, Samsung should be able to resolve it as it has for other regions. Samsung announced the Blood Pressure Monitor for their Watches more than 3 years ago.
Samsung is a giant company that certainly has the assets (cash & people) to get it done.

Likely, the FDA is the problem. Regardless, the US is a large market and Samsung should service the US customers accordingly.

[realaud]

Frankly, Samsung doesn't have to provide the feature at all, even though the watches are now manufactured with the sensors to do so, it is not approved and Samsung should either stop marketing it in the U.S. as having the feature, or change their marketing materials to state in bold print, not fine print, that the feature is not available in the U.S.  They have fulfilled their legal obligation of stating "may not be available in all regions", but it's in the tiniest of fine print.  

Samsung cannot just activate it on the watch, disclaimers notwithstanding, without FDA approval without sustaining a heavy fine. I understand their are third party apps available that will accomplish this function, but they are not anything I would trust if my life was going to depend on it.  Also, let us not forget that many of the health tracking features on Samsung watches are already wildly inaccurate, so why would I trust a blood pressure monitor feature (approved or unapproved)?

[userZRSCLYzCJC]

customers, all we are asking to get the Blood Pressure Monitor enabled by Samsung as they have done for customers in Canada and other regions.
Whatever the reason, Samsung should be able to resolve it as it has for other regions. Samsung announced the Blood Pressure Monitor for their Watches more than 3 years ago.
Samsung is a giant company that certainly has the assets (cash & people) to get it done.

Likely, the FDA is the problem. Regardless, the US is a large market and Samsung should service the US customers accordingly.

[realaud]

Oh, aren't we being elitist?  Samsung should pay attention to us AMERICANS. They are paying attention to us and they are working within our laws.  The law says they cannot activate the feature without FDA approval, so they are not. What were you doing for blood pressure monitoring before they announced this feature?  I assume you will continue doing the same until the feature is (if ever) approved.  You are not owed this feature.

[userZRSCLYzCJC]

Respectfully disagree with you.
The Blood Pressure Monitor app does work as proven in other countries and by people who were able to side load it in the US.
Sir, I am not an elitist by asking that something available be enabled here.
Further, not wanting to carry around a larger, heavier Blood Pressure Monitor when a smaller lighter one is available is not unreasonable.
When Samsung announced this feature I changed from Apple products to Samsung based on that announcement. I am glad that you don't have the physical problems I do, but you don't need to belittle people who could really use this app.
I do have one question, which you do not need to answer - why are you so defensive of Samsung and hostile in your reply?

[realaud]

You don't have to agree with me.  The fact of the matter is that the feature DOES NOT HAVE FDA approval. Period.  Therefore, it cannot be activated in the U.S. of A.  It does not matter whether it is active and works in other countries. What matters is it is not allowed to be applied HERE.  It's not Samsung's fault that you switched brands when this feature was announced without first verifying that it was active and functional.

Samsung does not need me to defend them, nor do I have a need to defend Samsung.  I do have a need for people to understand reality, and understand that the reason that the BP monitor is not functional in the US is because of the FDA.

I have my own health issues, but I do not and will not rely on my watch and/or phone to take the place of functional equipment already available to me.   And, I'm certainly not switching devices or tossing my equipment until I am sure that any phone/watch features are functional and accurate.

So, you think stating the fact that Samsung is following US Federal law is hostile? Facts are never hostile, they are facts.

[Members_slcjT5w]

Crappy position

[realaud]

Oh? But, it is mine. I think the crappy position is people expecting Samsung to activate a feature that requires approval, that has not been approved. And thinking that the FDA, especially the current FDA, cares about an individual's concern is a bad call, as well.