There’s an SOL on rape in most scenarios.

But no statute of limitations on copyright violations? WTF?

Open source wheelchairs; and a community of variously abled makers who can come together and build assemblies that are “not medical devices” but come together easily into something that could be used as such.

Speaking strictly for the US, and as a non-lawyer - I’m inclined to think that an open source wheelchair would probably sail right through the 510k process, but… Still doesn’t make that process cheap by any means.

I’ve had similar thoughts re: CPAP/APAP machines, neither the SW nor the HW is brutally complex / poorly understood. Pretty straightforward stuff mostly. But trying to distribute a thing like that even as plans is just asking for a C&D from the FDA, I’d expect.