12 Which of the following criteria is not used by the FDA to

12. Which of the following criteria is not used by the FDA to decide on market clearance of new devices?
a. Safety
b. Cost Effectiveness
c. Effectiveness

13. Is the following statement true or false: \"FDA performs clinical trials to determine whether a device is safe and effective for use in humans\"?
a. True
b. False

14. \"The FDA and CMS have different missions, but use the same criteria for their decision-making.\"
a. True
b. False

Solution

12. b. Cost Effectiveness .

This criterion is not used by FDA dor market clearance of device.

13.a. . True.

Human safety is of prime importance for FDA and for such purpose any new device is put to trial for human safety and effectiveness.

14. b. False

14.