US RAC EXAM REVIEW QUESTIONS WITH
VERIFIED ANSWERS
[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
[D] 30, 60, 75
[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
[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
[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
[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
[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
[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
[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
[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
[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
[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
[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
[B] Clearance, approval
[C] Permission, approval
[D] Clearance, notification
[B] Clearance, approval
[Q]If the FDA requests additional information while reviewing a 510 (k) submission, you
have ___ days to respond.
[A] 30
[B] 60
[C] 90
[D] 180
[D] 180
[Q]Which of the following are exempt from premarket notification?
[A] Custom devices
[B] Special devices
[C] Restricted devices
[D] None of the above
, [A] Custom devices
[Q]Form FDA ____, Blood Establishment Registration and Product Listing, is used for
submission of registration and product listing information to the FDA.
[A] 4030
[B] 2830
[C] 3356
[D] 1170
[B] 2830
[Q]Completion of Form FDA ____ is required for all establishments engaged in the
recovery, processing, storage, labeling, packaging, or distribution of any Human Cells,
Tissues, and Cellular and Tissue-Based Products (HCT/Ps), or the screening or testing of a
cell or tissue donor.
[A] 4030
[B] 2830
[C] 3356
[D] 1170
[C] 3356
[Q]A PMA has a __ day administrative review period and a __ day filing review period.
[A] 30, 60
[B] 15, 30
[C] 30, 45
[D] 15, 45
[D] 15, 45
[Q]Within __ days of receipt, the FDA must determine whether an NDA can be filed.
[A] 30
[B] 60
[C] 90
[D] 120
[B] 60
[Q]What type of meeting is an End of Phase 2 meeting?
[A] Type A
[B] Type B
[C] Type C
[D] Type D
[B] Type B
[Q]What type of meeting is a post-action meeting requested within three months after an
FDA regulatory action (other than an approval)?
VERIFIED ANSWERS
[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
[D] 30, 60, 75
[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
[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
[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
[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
[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
[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
[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
[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
[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
[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
[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
[B] Clearance, approval
[C] Permission, approval
[D] Clearance, notification
[B] Clearance, approval
[Q]If the FDA requests additional information while reviewing a 510 (k) submission, you
have ___ days to respond.
[A] 30
[B] 60
[C] 90
[D] 180
[D] 180
[Q]Which of the following are exempt from premarket notification?
[A] Custom devices
[B] Special devices
[C] Restricted devices
[D] None of the above
, [A] Custom devices
[Q]Form FDA ____, Blood Establishment Registration and Product Listing, is used for
submission of registration and product listing information to the FDA.
[A] 4030
[B] 2830
[C] 3356
[D] 1170
[B] 2830
[Q]Completion of Form FDA ____ is required for all establishments engaged in the
recovery, processing, storage, labeling, packaging, or distribution of any Human Cells,
Tissues, and Cellular and Tissue-Based Products (HCT/Ps), or the screening or testing of a
cell or tissue donor.
[A] 4030
[B] 2830
[C] 3356
[D] 1170
[C] 3356
[Q]A PMA has a __ day administrative review period and a __ day filing review period.
[A] 30, 60
[B] 15, 30
[C] 30, 45
[D] 15, 45
[D] 15, 45
[Q]Within __ days of receipt, the FDA must determine whether an NDA can be filed.
[A] 30
[B] 60
[C] 90
[D] 120
[B] 60
[Q]What type of meeting is an End of Phase 2 meeting?
[A] Type A
[B] Type B
[C] Type C
[D] Type D
[B] Type B
[Q]What type of meeting is a post-action meeting requested within three months after an
FDA regulatory action (other than an approval)?
