Earlier quoted context omitted.
You're talking about the Apple Watch, right? That's peanuts of regulatory compliance stuff compared to the amount of regulations related to building a car in the US market. The FDA requires this big fat disclaimer: > The ECG app is intended for over-the-counter (OTC)use. The ECG data displayed by the ECG app is intended for informational use only. The user is not intended to interpret or take clinical action based on…
That's not a disclaimer. That's (part of) the indications for use, which is a term of art. These are inherently narrowing statements, and they are in place to constrain what the company can market a device as, and gives the FDA a stick to beat you with if you aren't careful about this. If you follow the submission you'll also see they were granted approval to market as a de-novo filing as a class II device, so it's n…
That's like saying English is a transferable skill. Domain knowledge is what counts here. It's the same reason medical device makers don't try their luck in the automotive market and vice-versa.