RAC US Exam Question No 23

Question No 23:

While seeking a new Class III indication for a medical device that is currently on the market as Class II, a company received a vote of "non-approvable" from an FDA Advisory Panel. Possible course of action include all of the following EXCEPT?

A. Continue marketing the device for its Class II indication
B. Update the current labeling to include the new indication
C. Proceed with a PMA submission to FDA
D. Request a face-to-face meeting post-panel meeting with FDA

Answer: B