Hi,
I'm working and trying to get FDA Breakthrough device for AI software medical device.
There is no predicate device of my device, so I was working to get FDA Breakthrough device before we submit De novo application.
But suddenly, my competitor got FDA Breakthrough device recently for their device which is similar of ours(mostly same intended use and operation of principle).
Can we get second FDA Breakthrough device in this case?
Highly appreciate in advance !
I'm working and trying to get FDA Breakthrough device for AI software medical device.
There is no predicate device of my device, so I was working to get FDA Breakthrough device before we submit De novo application.
But suddenly, my competitor got FDA Breakthrough device recently for their device which is similar of ours(mostly same intended use and operation of principle).
Can we get second FDA Breakthrough device in this case?
Highly appreciate in advance !