We've been developing a medical device and going through 510(k) exemption. Great write-up, and to add to it, 2 things that were missing. 1) 510(k) exemption i

We've been developing a medical device and going through 510(k) exemption. Great write-up, and to add to it, 2 things that were missing. 1) 510(k) exemption is where we can point to a predicate device and say "we're so similar to these other devices, that we don't even need to go through the 510(k) process. This is only for low-risk devices. 2) When a predicate device is removed from the market, even if for a safety reason, the devices which received 510(k) approval or exemption are not automatically removed from the market as well! Having said that, it appears the system is working. The QA and documentation requirements seem to be putting enough administration to provide mostly quality products. It doesn't seem the market is awash in harmful products that don't provide benefits. With the exception of Philips having been raked over the coals the last few years with their CPAP issues, are there other major issues with medical devices?