RAC US Exam Question No 34

Question No 34:

A new device undergoes design review. The review determines that current analytical data do not provide enough information to move ahead with human testing. A decision is made to discard the data and being a new study with the same protocol. This is an acceptable approach if:

A. The intended use of the product does not change
B. The original data are destroyed before new testing starts
C. the original data are stored in the device deign history file
D. The new study tests three times as many samples as the ole one.

Answer: C