RAC Matrix Questions (Device)
Study online at https://quizlet.com/_i2spbq
1. [Q]Which meeting is held with the FDA for the purpose of reaching concur-
rence 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
2. [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
3. [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
4. [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
5. [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
6. [Q]Which 510 (k) do you file where the device modification does not affect its
intended use?
, RAC Matrix Questions (Device)
Study online at https://quizlet.com/_i2spbq
[A] Traditional
[B] Standard
[C] Abbreviated
[D] Special: [D] Special
7. [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
8. [Q]If the FDA requests additional information while reviewing a 510 (k) sub-
mission, you have ___ days to respond.
[A] 30
[B] 60
[C] 90
[D] 180: [D] 180
9. [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
10. [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
11. [Q]Within __ days of receipt, the FDA must determine whether an NDA can
be filed.
[A] 30
[B] 60
, RAC Matrix Questions (Device)
Study online at https://quizlet.com/_i2spbq
[C] 90
[D] 120: [B] 60
12. [Q]A sponsor may request a meeting to discuss a device application's review
status and obtain additional information to complete the PMA review.
[A]Determination Meeting
[B]Agreement Meeting
[C]Day-100 Meeting
[D]Pre-submission meeting: [C]Day-100 Meeting
13. [Q]which device establishment does not need to register with agency?
[A] Contract manufacturer
[B] Foreign manufacturer
[C] Custom device manufacturer
[D] Domestic Distributors: [D] Domestic Distributors
14. [Q]which activity would a user fees apply?
[A] IND submission
[B] IDE submission
[C] Amendment to an IND
[D] Updating product listing: [D] Updating product listing
15. [Q]which is not a possible outcome for a PMA?
[A] Major Deficiency Letter
[B] Approvable
[C] Cleared for marketing
[D] Approval Letter: [C] Cleared for marketing
16. [Q]How long is the review period for 510ks?
[A] 45 days
[B] 60 days
[C] 90 days
[D] 180 days: [C] 90 days
17. [Q]A 510K submission for any class III device must include a:
[A] Clinical results summary
[B] Hazards analysis evaluation
Study online at https://quizlet.com/_i2spbq
1. [Q]Which meeting is held with the FDA for the purpose of reaching concur-
rence 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
2. [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
3. [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
4. [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
5. [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
6. [Q]Which 510 (k) do you file where the device modification does not affect its
intended use?
, RAC Matrix Questions (Device)
Study online at https://quizlet.com/_i2spbq
[A] Traditional
[B] Standard
[C] Abbreviated
[D] Special: [D] Special
7. [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
8. [Q]If the FDA requests additional information while reviewing a 510 (k) sub-
mission, you have ___ days to respond.
[A] 30
[B] 60
[C] 90
[D] 180: [D] 180
9. [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
10. [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
11. [Q]Within __ days of receipt, the FDA must determine whether an NDA can
be filed.
[A] 30
[B] 60
, RAC Matrix Questions (Device)
Study online at https://quizlet.com/_i2spbq
[C] 90
[D] 120: [B] 60
12. [Q]A sponsor may request a meeting to discuss a device application's review
status and obtain additional information to complete the PMA review.
[A]Determination Meeting
[B]Agreement Meeting
[C]Day-100 Meeting
[D]Pre-submission meeting: [C]Day-100 Meeting
13. [Q]which device establishment does not need to register with agency?
[A] Contract manufacturer
[B] Foreign manufacturer
[C] Custom device manufacturer
[D] Domestic Distributors: [D] Domestic Distributors
14. [Q]which activity would a user fees apply?
[A] IND submission
[B] IDE submission
[C] Amendment to an IND
[D] Updating product listing: [D] Updating product listing
15. [Q]which is not a possible outcome for a PMA?
[A] Major Deficiency Letter
[B] Approvable
[C] Cleared for marketing
[D] Approval Letter: [C] Cleared for marketing
16. [Q]How long is the review period for 510ks?
[A] 45 days
[B] 60 days
[C] 90 days
[D] 180 days: [C] 90 days
17. [Q]A 510K submission for any class III device must include a:
[A] Clinical results summary
[B] Hazards analysis evaluation
