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notjulianjaynes10/12/20240 repliesview on HN

There already exists some limitations from the FDA regarding software. For example if you receive clearance (NB this is different than approval) for a device which uses AI, it cannot modify its own source code and any changes need to go through the clearance process again. (Or something like that it's been a while since I looked this up.)

I don't know that this is how things are currently structured, but if a company was required to submit a device's source code as a condition of receiving a 510(k) clearance perhaps there should also be a condition that the FDA can release this code in instances where the public interest in doing so would outweigh the IP interests of some piece of abandonware.

Yeah who am I kidding that won't happen.