Non Invasive Blood Glucose Test
Legal process for non-invasive blood glucose test. We have a new device for that, is there a way we can push to the market without fda approval? If no, then what would be the process for class i approval?
John |Director of anesthesia
There is no way to push through use in hospital without FDA approval. No hospital would accept that ...3.9 Hours Later
No, these are all Class II devices requiring a 510(K) submission. Please contact me at fdaquality@y...3.9 Hours Later
I can provide assistance, I am a retired US FDA officer with medical device *****ledge....5.2 Hours Later