Rac Practice Exam 1 . Test 2024 Questions And Answers

Procedures for identifying the control number for each unit, lot or batch of finished devices is required for which type of medical device? A Surgical gloves, B Xray machines, C Pacemakers, D Syringes {Ans: C) Pacemakers}A medical device may be exported under Section 801(e) of the Food, Drug, and Cosmetic Act provided that all of the following apply for the device EXCEPT: A It is in accordance with the specifications f the receiving country, B It is not in conflict with the laws of the recieving country , C It is 510k cleared or PMA approved, D It is labeled on the outside of the shipping carton for export to the receiving country. {Ans: It is 510(k) cleared or PMA approved}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 courses of action include all of the following EXCEPT: A Continue marketing the device for its Class, B Update the current labeling to include the new indication, C Proceed with a PMA submission to FDA., D Request a facetoface postpanel meeting with the FDA