Device rac - Study guides, Class notes & Summaries

DEVICE RAC EXAM 2024 | 70 Questions with 100% Correct Answers | Verified | Latest Update 2024| Graded A+

DEVICE RAC EXAM QUESTIONS AND ANSWERS| VERIFIED ANSWERS 2022-2023,DEVICE RAC EXAM QUESTIONS AND ANSWERS| VERIFIED ANSWERS 2022-2023,DEVICE RAC EXAM QUESTIONS AND ANSWERS| VERIFIED ANSWERS 2022-2023

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 - 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. Abbreviated 510...

DEVICE RAC EXAM QUESTIONS AND ANSWERS WITH COMPLETE SOLUTIONS ASSURED A+. 1. 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 2. 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 requir...

DEVICE RAC EXAM QUESTIONS AND ANSWERS 2024 WITH COMPLETE SOLUTION

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 - correct 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....

Device RAC Exam Questions and Answers | Latest Update | 2024/2025 | Already Passed What is the role of regulatory affairs professionals in the medical device industry? A) To ensure compliance with regulations and guidelines B) To create marketing strategies C) To design medical devices D) To conduct clinical trials What does a De Novo classification request pertain to? A) Devices that are already on the market B) Devices that are novel and have no predicate C) Devices undergoing...

DEVICE RAC EXAM QUESTIONS AND ANSWERS | LATEST UPDATE | 2024/2025 | 100% PASS What is the primary purpose of regulatory affairs in the medical device industry? A) To market devices effectively B) To ensure devices are safe and effective for public use C) To manage device recalls D) To design new medical devices Which regulatory body oversees the approval of medical devices in the United States? A) Federal Trade Commission (FTC) B) Food and Drug Administration (FDA) C) Centers for ...

Device RAC Exam Questions with 100% Correct Answers | Verified | Latest Update

Device RAC Exam With Correct Questions And Answers With complete solution A physician reports to a manufacturer that a patient was hospitalized with acute sepsis after treatment with an approved device. This side effect is not listed in the package insert. This event must be reported by the manufacturer to FDA no later than: A. 5 calendar days B. 15 calendar days C. 30 calendar days D. The next quarterly or annual report - C If a device failure is occurring with greater than expected...