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.

[fyplovely]

The FDA can't even be bothered to test out and trial herbal vitamins that are sold throughout every supermarket and gas station, I doubt they're going to get on top of this. It would definitely be nice though. The FDA doesn't generally care about humans, they just want to justify earning an income for themselves so they don't flip burgers at McDonald's.

[The_Chief]

I'm not disputing that: FDA is largely a paid rubber stamp for Big Pharma. However, manufacturers like Samsung can't activate a health monitoring function like blood pressure without FDA approval: so if we want that feature, we need to bombard FDA... not Samsung.

[realaud]

Vitamins and supplements are specifically excluded from FDA approval, so that any huckster can peddle any poison to the gullible.

[fyplovely]

That's because the FDA is absolutely useless and we're giving people money that have the qualifications and skills to work at McDonald's

[Oxford]

Sorry to burst your bubble, but this has been going on to for many years. I don't think the FDA is in any hurry to approve this. Furthermore, this is a peer-to-peer user forum, meaning no one from Samsung or the FDA is going to see your post.

[realaud]

Chillax, the poster said that it was a copy of the letter he actually wrote to the FDA as an example for others if they wanted to follow suit.

[Raj_P]

Samsung is the one that needs to be blamed here. Samsung hasn't sent devices or requested for FDA approval for their watches. 😠 #Samsung #Blame #Devices #Approval #Watches

[user9ZoJOdawUv]

There are costs to applying for regulatory clearance. While it is my understanding that Samsung has indeed submitted an application to the FDA, it is not uncommon for device manufacturers to seek low cost approvals first. In the world of regulation, the FDA is considered quite expensive and slow, and with the growth of the European and Asian markets, some manufacturers do not consider FDA approval for US market access worth the cost.

Samsung's culpability is in not making it readily clear on their US store page that BP readings are disabled. That would cost almost nothing, aside from stopping erroneous purchases.

[userpMgFwKaOxb]

The FDA will likely grant approval for BP monitoring with a Galaxy Watch when Samsung can demonstrate that its GW meets the FDA's standards for "Software as a Medical Device." The hardware is probably sound. The software is probably the culprit, and IF Samsung has submitted it to the FDA, it apparently does not meet muster. The FDA knows that people have expectations for devices that people will use as medical devices and won't OK it unless it works as it is supposed to work. "Close enough for government work" is not good enough for medical devices. Besides, Samsung has deep pockets, and they want to make sure that it works up to US standards. As much as it is the right thing to do, it is also the legal thing to do and a CYA thing to do. They don't want to be sued either.

Samsung has received FDA approval for ECG and Passive Sleep Apnea Detction. These approvals utilize the same PPG detectors that BP monitoring uses, but their software components needed approval, too. That's why I say FDA approval for BP monitoring is likely contingent on software. If it has been submitted and failed, they should fix it and resubmit.