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Comment by HeyLaughingBoy | Hacker News Reader

I don't know if you have an organization around you or not, but be careful. If your software is actually producing some sort of a quantitative or even qualititative "you have this visual defect or not" then the FDA may very well consider you a Medical Device and you'll have to go through submission, etc.

There are a lot of small businesses out there that are unwittingly (and illegally) producing medical devices and don't even know it (yet!).

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We will be going through the long and arduous FDA and CE approval process. This is a big part of the cost.

Best of luck with that. As someone who has taken medical imaging software through both, my preference would be to get CE marking first and allow the market and the device to become establish before going for a 510K. The FDA predicate device process together with the glacial speed of the agency means making modifications to a system is unnecessarily difficult which is something you will need to do when innovating in a market. I find the CE process to be a more pragmatic approach.

On some of the darker days with the FDA - and despite their 90 day target we had over 900 days between submission and final clearance - I found it helped to remember the famous Churchill quote; "When you are going through hell, keep going."

Thanks for the advice. We already have experience with the CE process, it's painful but doable. The manufacturing company has been cleared for FDA before, so for now I remain optimistic. (Famous last words...)

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