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Download Regulatory Affairs Certification (RAC) US Exam Dumps
NEW QUESTION 27
According to the GHTF IVD guidance, which of the following is the CORRECT classification for a blood glucose self-testing kit?
Answer: A
NEW QUESTION 28
A company is developing a device-drug combination product. Which of the following should be evaluated FIRST in order to determine the applicable guidance documents?
Answer: B
NEW QUESTION 29
The requirements for document control are located in which of the following documents?
Answer: C
NEW QUESTION 30
Why is it necessary to run supplemental safety pharmacology studies?
Answer: B
NEW QUESTION 31
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