RAC-US Exam Dumps | A company is currently marketing an implantable orthopedic medical device. The R&D department is

<< Prev Question Next Question >>

Question 2/34

A company is currently marketing an implantable orthopedic medical device. The R&D department is planning to change the material used for the implant. The R&D department states that the change does not impact the safety and effectiveness of the product.
What action should the regulatory affairs professional take FIRST?

A. Write a memo to file since the change does not impact product safety and effectiveness.

B. Review the content of change and supporting data for the equivalency with the current material.

C. No action is needed in this situation.

D. Prepare regulatory submissions that detail the medical device's change in materials.

Question 2/34

LEAVE A REPLY

Download PDF File