The types of Q-Subs covered by this guidance in detail are listed in Sections II.A-E of this guidance. Some other submission types are noted solely to indicate that they are tracked with a “Q” number and should be submitted following the processes for Q-Subs, while their details and processes are covered in separate guidance documents (see Sections II.F and G of this guidance).
Finally, there are other interactions with FDA that are outside the scope of the Q-Sub program (Section II.H of this guidance).