US RAC PRACTICE EXAM 2024-2025 /COMPLETE QUESTIONS AND
CORRECT ANSWERS (100% CORRECT ANSWERS ) A GRADED.
[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 - ANSWER-[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 - ANSWER-[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 -
ANSWER-
[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
[D] 30, 60, 75 - ANSWER-[D] 30, 60, 75
[Q]How often does a drug product listing need to occur?
[A] Annually
[B] Every June and December
[C] Quarterly
[D] Once - ANSWER-[B] Every June and December
[Q]Upon receipt of a complete PMA, how many days does the FDA
have to approve or not approve the PMA?
[A] 90
[B] 120
[C] 150
[D] 180 - ANSWER-[D] 180
[Q]What is the one section that is required in an NDA but not in a
BLA?
[A] CMC
[B] Clinical data
[C] Field copy certification
[D] Microbiology - ANSWER-[C] Field copy certification
,[Q]What are the possible outcomes to a PMA?
[A] Approval, unacceptable, refusal
[B] Acceptance, pending, rejected
[C] Approval, Approvable, not approvable, denial
[D] Approval letter, complete response letter, refuse to file letter -
ANSWER-[C] Approval, Approvable, not approvable, denial
[Q]What are the possible outcomes to an NDA?
[A]Approval, unacceptable, refusal
[B]Approval letter, complete response letter, refuse to file letter
[C]Approval, not approvable, denial
[D]Acceptance, pending, rejected - ANSWER-[B]Approval letter,
complete response letter, refuse to file letter
[Q]What is the approval timeline for a priority NDA versus a standard
NDA?
[A] 10 months, 12 months
[B] 6 months, 10 months
[C] 6 months, 12 months
[D] 12 months, 18 months - ANSWER-[B] 6 months, 10 months
[Q]A new drug is any drug not generally recognized as safe and
effective before ____.
[A] 1964 [B]
1948
[C] 1927
[D] 1938 - ANSWER-[D] 1938
, [Q]A 510 (k) is required for ____ Class I devices and ____ Class II
devices.
[A] Some, most
[B] All, all
[C] All, most
[D] Most, some - ANSWER-[A] Some, most
[Q]Which 510 (k) do you file where a guidance document exists that
provides reasonable assurance that the device's safety and
effectiveness have been established?
[A] Traditional
[B] Standard
[C] Abbreviated
[D] Special - ANSWER-[C] Abbreviated
[Q]Which 510 (k) do you file where the device modification does not
affect its intended use?
[A] Traditional
[B] Standard
[C] Abbreviated
[D] Special - ANSWER-[D] Special
[Q]A determination of substantial equivalence to a 510 (k) implies
________ to market the device, not ________ to market the device.
[A] Approval, clearance
