The FDA classifies these devices as high-risk because they might give a false result but completely ignores the guaranteed harm of not having them at all. It’s a system that punishes action and rewards delay.
Both false positives and false negatives are harmful. False positives will send people to the hospital for no reason and divert resources from people with real emergencies - not to mention leaving them with a large ER bill to pay. False negatives will result in people with actual heart attacks dismissing their symptoms and dying.
I think the FDA safety margin for things like this should be more “this has no actual obvious harm to use, it has a plausible mechanism of action to help + isn’t fraudulently measuring what it claims to measure and its science backed.
Something like this hits all the targets already.
But the failure scenario is not death. It's an unnecessary hospital visit. And you STILL want it banned. If someone wants early heart-attack warnings at 92% accuracy, that should be their call.
As for costs, a few thousand false alarms might clog ERs and bill wallets, but big deal. That’s the price of getting these things in the wild and learning what actually works. More wearables in real world situations equals massive real-world data, faster device improvement, economies of scale, and ultimately, over the long run, millions of prevented heart attacks — plus orders-of-magnitude lower costs down the road. I’d take a handful of extra ER visits any day if it speeds up innovation and saves lives.
They allow a summary report. They don't require a clinical human trial. They barely care if you follow the FCC and safety requirements for electronics in general. This does not look burdensome.
See the "clinical studies" section here:
https://www.fda.gov/medical-devices/guidance-documents-medic...
"designs dissimilar from designs previously cleared under a 510(k), such as those incorporating significant new features or algorithm techniques new technology, i.e., technology different from that used in legally marketed arrhythmia detectors indications for use dissimilar from arrhythmia detector and alarm devices of arrhythmia detectors of the same type."
And those studies aren’t cheap. A Phase II cardiovascular feasibility trial runs roughly US$7 million. If you go pivotal (Phase III), you’re easily in the $11.5 million–$53 million range. Source: https://www.sofpromed.com/what-is-the-cost-of-a-clinical-tri...
We absolutely cannot create a hacker culture of medical devices with these kinds of costs, and in the long run, not having a hacker culture is going to massively slow innovation, and with it, the opportunity to reduce the cost of healthcare and improve the quality.
Nope! Special class II is all the general class II requirements plus the special rules: https://www.fda.gov/medical-devices/overview-device-regulati...
Specifically in this case I chose this classification because the only difference is the alarm. Without an alarm or alert, you're normal Class II. The alert bumps you up to the special rules. A wearable device would have an alert.
> See the "clinical studies" section
I see where it says "clinical studies will not be needed for most arrhythmia detector and alarm devices [...] FDA will always consider alternatives to clinical testing when the proposed alternatives are supported by an adequate scientific rationale."
They recommend ANSI guidelines and standards for algorithms to measure ST length and for the electrodes. They don't even require following them. The clinical requirements are for all of the crazies who want to do crazy things like sell mood rings for heart attacks. It is very unlikely they would require a premarket clinical trial(NOTE that they allow many products to register as investigative!) for something like an apple watch.
Medical device regulations are a paper tiger. The effort in development is the concern- you can't register until the development is paid for, so if you're rejected then you've wasted all that money. Registering could be zero effort and that would not change. Especially for companies like apple, it is much more convincing that they are more concerned with patient lawsuits than problems with the FDA.
And yes, the FDA will require pre-market clinical data. The FDA required a clinical study for the Apple Watch ECG:
https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN180044.p...
Apple also ran the Apple Heart Study which had 419,000 subjects to validate the algorithm:
https://www.nejm.org/doi/full/10.1056/NEJMoa1901183
Median cost for a U.S. pivotal cardiovascular‑device trial: ≈ $19 million:
https://jamanetwork.com/journals/jamanetworkopen/fullarticle...
You're right that a company like Apple could afford it. However, the type of small company or small group that would form the base of a hacker culture cannot afford these kinds of clinical studies just for an experimental product. We need more experimental products being used in the market to get a faster rate of innovation.
"NOTE that they allow many products to register as investigative!"
Receiving the Investigational Device Exemption does NOT allow the device to be commercially sold or mass-distributed to the general public. The IDE just lets the device be used in human clinical trials. That's it.
Well medical devices aside, the legal framework around anything, including business, manufacture etc. is more impeding while failing to address things like environmental destruction/pollution which causes real harm. ( notice, that I did not say climate change, a separate subject).
It all makes sense when one sees it either though the lens of either corruption of more likely human stupidity - where a bunch of rules give people the comfort of being protected.
Also you can already buy home ECG devices for a couple hundred bucks. Not sure if there is some history of being banned in the past or whatever, but otherwise I'd guess the main problem is just a lack of much interest in the market.