PMA Questions

Question 1

For a Class III devices, what controls are required to demonstrate safety and effectiveness of the device?
A. General and special controls
B. Special controls and valid scientific evidence
C. General controls, special controls and valid scientific evidence
D. General controls and valid scientific evidence

Answer 1

c. General controls, special controls and valid scientific evidence

Question 2

2. For a Class III device when does the Premarket Approval Inspection by FDA personnel occurs?
   A. Within two years following PMA approval
   B. Before the substantive review process
   C. After the PMA Approval
   D. After IDE study

Answer 2

B. Before the substantive review process

Question 3

3. Which of the following is NOT an FDA Action on PMA?
A. Approvable letter 
B. PMA Clearance
C. Approval order
D. Denying approval

Answer 3

B. PMA Clearance

Question 4

Which PMA application method is recommended for products that are in early stage of clinical study?
A. Product Development Protocol (PDP)
B. Traditional PMA 
C. Humanitarian Device Exemption 
D. Modular PMA

Answer 4

D. Modular PMA

Question 5

5. When are the Post approval requirements imposed by FDA?
A. At the time of PMA approval
B. Subsequent to approval 
C. Before the approval 
D. Both a and b

Answer 5

D. Both A and B

Question 6

A PMA holder must:
A. Report death and serious injury that a device has caused/contributed.
B. Establish and maintain adverse events files
C. Submit summary annual reports
D. All of the above

Answer 6

D. All of the above

Question 7

Changes are being made to a Class III devices and it has a significant impact on the safety and effectiveness of the device, the manufacturer must: 
A. Immediately notify FDA
B. Submit a PMA amendment 
C. Submit a Traditional PMA 
D. Submit a PMA supplement

Answer 7

D. Submit a PMA supplement

Question 8

When is a PMA supplement NOT required?
A. Changes does not affect safety and effectiveness of the device.
B. Change is reported in post-approval studies.
C. Change in the color of label
D. All of the above

Answer 8

D. All of the above

Question 9

A Class III device manufacturer is making some modification to the manufacturing procedure that affect the safety and effectiveness of the device and the manufacturing site remain the same. The Class III manufacturer must: 
A. Submit a Special PMA 
B. Submit a Site change supplement. 
C. Include it in the Annual 
Report/30-day supplement
D. Submit a 30-day notice

Answer 9

D. Submit a 30-day notice

Question 10

A Class III device manufacturer is making changes to its device labeling based on the feedback received in the post-market surveillance process, changes are being made to enhance the safety of the device, the manufacturer must: 
A. Submit a PMA supplement 
B. Submit a 30-Day notice
C. Special PMA Supplement
D. Real-Time Supplement

Answer 10

C. Special PMA Supplement

Question 11

A Class III device manufacturer is changing its packaging facility to a new location which was not part of the original PMA supplement, the manufacturer is planning to submit a Manufacturing Site change Supplement to the FDA, what is the timeline that manufacturer has to consider for its approval?
A. 30-Day notice or 135-day PMA Supplement
B. Can immediately start using the new facility after submitting the supplement
C. Include the change is the annual report
D. 180-Day PMA Supplement

Answer 11

D. 180-Day PMA Supplement

Question 12

During the substantive review process of a Class III medical device, the reviewer has some concerns about the manufacturing information and has requested the manufacturer to provide some additional information that is necessary to complete PMA review. The manufacturer should immediately:
A. Request an informal hearing
B. Submit a PMA amendment
C. Submit a PMA manufacturing site change supplement
D. Submit a Panel Track Supplement

Answer 12

B. Submit a PMA amendment