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That's awesome! At least in my limited experience developing health care hardware is much more challenging when there isn't a clear "regulatory path" that has b
by roland35 3y ago
That's awesome! At least in my limited experience developing health care hardware is much more challenging when there isn't a clear "regulatory path" that has been done before. Which makes it harder for completely novel devices (eg versus making an improved pacemaker which already has been approved)
- ijustlovemath 3y agoThe good thing for us is that artificial pancreases are regulated not as one device, but as three separate (interoperable) devices: the pumps, the sensors, and the control software. Only our control software is under a de-novo pathway ("totally new thing" pathway), everything else is 510k ("we know what this thing is" pathway). We also have Breakthrough Device designation, which really accelerates the regulatory timeline