3 ms·
As much as I am in favor of cutting red tape, medical devices should not be received in 30 days max.
by dannyw 2y ago
As much as I am in favor of cutting red tape, medical devices should not be received in 30 days max.
- cruffle_duffle 2y agoWhy? I do this sort of technique all the time at work to keep things moving. “I’m gonna ship this code on Friday and if I don’t hear anything before then I’ll assume no news is good news and do it!”. There should always be an upper bound to how long somebody can block your progress. If something was so important that they want to block me, why didn’t they tell me before Friday? That was ample time to raise objections. It’s just an SLA and holds people accountable.
- ijustlovemath 2y agoReally what happens is your application is given a higher priority level and dedicated reviewers. They're still going through the full review process, its just they're focusing on your submission.
- danudey 2y ago"Breakthrough" devices have to be devices which show a significant improvement to quality of life over existing treatments for "life threatening or irreversably debilitating" conditions, using breakthrough technology in a space where an existing device doesn't exist yet. So it's less "we made a better pacemaker that uses ChatGPT" and more "this new ventilator can keep people alive even when their lungs are filling with fluid and they're going to die otherwise".