@ppp23: if you are asking about what it is, it stated on that document that “Design output means the results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. The total finished design output consists of the device, its packaging and labeling, and the device master record.”
I don’t fully understand the 2nd questions, could you elaborate a bit more?
(Please tag me in your reply)