|
|
|
|
|
|
by teuobk
825 days ago
|
|
|
I've worked on the hardware and firmware design and implementation for many medical devices, almost all of which were approved via the 510(k) process. I always found it a mixture of amusing and bemusing that we'd have to tell the FDA, effectively, "Look at how similar this thing is to existing stuff!" while at the same time telling the Patent Office, "Look at how new and novel this thing is!" |
|
|