RAC-US Exam Dumps | In the process of obtaining a product approval, a regulatory affairs professional discovers that the

<< Prev Question Next Question >>

Question 12/34

In the process of obtaining a product approval, a regulatory affairs professional discovers that the product does not meet one of the specific technical requirements of the regulation.
However, competitors with substantially similar products have claimed compliance with the requirement and received approval. Which action should the regulatory affairs professional take FIRST?

A. Notify senior management that the product cannot be registered.

B. Discuss with the regulatory apriority and attempt to reach an acceptable solution.

C. Inform the regulatory authority that such a requirement is not applicable to the product.

D. Inform the internal departments to redesign the product to comply with this requirement.

Question 12/34

LEAVE A REPLY

Download PDF File