DEVICE RAC EXAM STUDY GUIDE Questions with 100% Correct Answers | Latest Version 2024 | Verified

510(k) Premarket Notifications for all of the following medical devices would be reviewed by CDRH's Office of Device Evaluation except: A) High Flux Hemodialyzer B) Blood specimen collection device C) Piston syringe D) Cardiopulmonary bypass blood tubing - B A 510(k) submission for any Class III device MUST include: A. Clinical results summary B. Hazards analysis evaluation C. Stability evaluation D. Certification and summary - D A clinical study sponsor's representative conducts periodic monitoring site visits for all of the following purposes EXCEPT to: A. Review raw data B. Ensure compliance with the protocol C. Review the protocol with the investigator D. Ensure the adequacy of the IRB and its procedures - D A company has been given a product from its British subsidiary to market for the first time in the US. The product is marketed in the EU. A project team gathered by the regulatory professional to review the information available for regulatory submission to FDA should: A. Focus on labeling and marketing since mutual recognition does not require complete technical reviewB. Include production, marketing, QA and clinic