US RAC Practice Exam | 200 Questions with 100% Correct Answers | Verified | Latest Update 2024

[Q]Which meeting is held with the FDA for the purpose of reaching concurrence on the key parameters of the investigational plan for a Class III device? [A] Agreement meeting [B] Determination meeting [C] Presubmission meeting [D] PMA Day-100 meeting - [A] Agreement meeting [Q]Which meeting held with the FDA is necessary for an otherwise stalled drug product development program to proceed? [A] Type A [B] Type B [C] Type C [D] Type D - [A] Type A [Q]Which type of meeting is held with the FDA for a Special Protocol Assessment? [A] Type A [B] Type B [C] Type C [D] Type D - [A] Type A [Q]Within how many days after FDA's receipt of a written request for a meeting should the following meetings occur: Type A, Type B, Type C [A] 15, 30, 45 [B] 30, 45, 60 [C] 30, 60, 90