RAC US Exam Question No 19

Question No 19:

A US medical device contract manufacturer has customers for whom it manufactures medical device components (parts) and finished medical devices. To date, all products have been either parts for Class II medical devices or Class II finished medical devices. The manager of new business contacts the regulatory manager to assess the impact of a possible new customer involving a Class III device. What is the first question the regulatory manager should as in order to begin assessing the impact of Class III on plant operpations?

A. Is it a sterile device?
B. Is it a component or device that would be manufactured?
C. Is it an implantable device?
D. Is it a single use device?

Answer: B