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 not as much work as a PMA but the regulatory work is not peanuts. Since then they have self-predicated for a 510(k) on a newer version.
Even for a smallish software only project like this, it means they had to set up all the basic infrastructure and have it audited. They also wrote a ton of formal engineering process documentation, a full design history file, etc. These skills at least are pretty transferable.
>Even for a smallish software only project like this, it means they had to set up all the basic infrastructure and have it audited. They also wrote a ton of formal engineering process documentation, a full design history file, etc. These skills at least are pretty transferable.
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.
It doesn't mean you easily set up shop in the other domain, sure. But the two processes are much closer than never having worked in a regulated environment. Especially at a corporate level, you have a much better idea of what is involved if you have been successful in one domain.
You'd have to hire a bunch of people with domain knowledge, but you are better off than starting from scratch.
If I am hiring engineers for aerospace, I'd rather bring someone in from medical devices than no regulatory experience, all else equal. Same in the other direction. Principle extends reasonably.
I guess there are lots of reasons I'd think it would be a big jump for apple, but "they won't get their head around the regulatory requirements" isn't really one of them.
I'm am engineer working in both spaces for 20 years. They do carry over. The principles are the same - much of it came out of the aerospace programs of the 50s, 60s and 70s.
English is a transferable skill, learning new languages is a skill also, being a successful bi or tri lingual person is a skill.
There are many many engineering and manufacturing companies who specialize in being suppliers for regulated industries. Like machine shops that specialize in aerospace, medical and automotive parts. Electronics manufacturers that do the same. At that level its more about process control and running a smooth operation and not the specifics of the application.
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 not as much work as a PMA but the regulatory work is not peanuts. Since then they have self-predicated for a 510(k) on a newer version.
Even for a smallish software only project like this, it means they had to set up all the basic infrastructure and have it audited. They also wrote a ton of formal engineering process documentation, a full design history file, etc. These skills at least are pretty transferable.