Comment by ETH_start | Hacker News Reader

Comment by ETH_start | Hacker News Reader

Parent Full thread

This is for arrhythmia detectors which are under a special class 2 restriction, not under the standard class 2 restrictions. Standard class 2 restrictions are more stringent. Secondly, even with arrhythmia detectors, clinical studies will be needed with any new design.

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.

> Standard class 2 restrictions are more stringent.

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.

You're right, but it is actually not the general class 2 that electrocardiographs are under, it's Class II (performance standards).

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.

Reply on news.ycombinator.com