Free Access RAPS.RAC-US.v2022-06-05.q36 Practice Test (Page 5)

Question 16

Which of the following is the BEST approach for mitigating potential regulatory compliance issues at your company?

A.Train all new employees on regulatory compliance processes and assign a mentor to them.

B.Document any failure to follow regulatory compliance processes in employee performance reviews.

C.Develop documented procedures for regulatory compliance processes and train personnel.

D.Train employees on all regulatory compliance processes using state-of-the-art systems.

Question 17

According to ISO 14971, what is the FIRST step when developing a risk management plan for a medical device?

A.Risk management

B.Risk analysis

C.Risk control

D.Risk estimation

Question 18

During a routine review of promotional materials for a product, a regulatory affairs professional discovers an off-label indication. Which of the following would be the FIRST follow-up action for the regulatory affairs professional to take?

A.Allow doctors to use the product for the off-label indication.

B.Request that doctors stop using the product for the off-label indication.

C.Communicate with the sales department to stop using the promotional materials.

D.Contact the marketing department to recall the product.

Question 19

A company is developing a new medical device using innovative technology. Which of the following is MOST critical in working with regulatory authorities?

A.Follow-up meeting after submission

B.Early collaboration

C.Documented agreement

D.Frequent communication

Question 20

When applying for marketing approval of a drug for a rare disease, which requirement can be waived?

A.Pre-clinical studies

B.Phase I clinical trials

C.Phase III clinical trials

D.Phase I and II clinical trials

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