Device rac exam qa - Study guides, Class notes & Summaries

RAC Devices Exam Questions with 100% Correct Answers What are the 5 general requirements for conformity assessment? - Answer- 1. Quality Management System (QMS) 2. Postmarket surveillance system (PMS) 3. Technical Documentation Summary 4. Declaration of conformity 5. Manufacturer and medical device registration with regulatory authority What is a design space? - Answer- The multidimensional combination and interaction of input variables and process parameters that have been demonstrat...

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. St...

RAC (Device) Exam Prep Q&A

Which division would have primary jurisdiction over a vascular graft with an antibiotic based on primary mode of action? A. CDER B. CBER C. CDRH D. OCP - Answer- C A company wants to modify its legally marketed device such that the modification does not affect the intended use or alter the fundamental scientific technology of the device. If the design outputs of the modified device meet the design input requirements, this change would be best filed as a(n): A. Special 510(k) B. Abbrevia...

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 ...