Device rac exam 2024 - Study guides, Class notes & Summaries

Device RAC Exam Questions and Answers 2023-2024 with complete solution

DEVICE RAC EXAM QUESTIONS CORRECTLY ANSWERED 2024. 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 chan...

DEVICE RAC EXAM QUESTIONS AND ANSWERS WITH GUARANTEED PASS 2024 LATEST UPDATE The initial importer of a medical device MUST: A. Report incidents in which a device may have caused or contributed to a death or serious injury B. Maintain quality assurance files C. Share responsibility for submittals with other distributors D. Report device malfunctions in an annual report - Answer A During a monitoring visit, the sponsor discovers that an investigator had used a device in a clinical inv...

RAC 2016 US RAC Practice Exam Questions and Answers | Latest Update | 2024/2025 | 100% Pass What is the primary focus of the FDA's Good Manufacturing Practices (GMP)? A) To reduce costs in manufacturing B) To ensure quality and safety in the production of medical devices C) To speed up the approval process D) To enhance marketing strategies What is the main purpose of a Risk Management File? A) To list all marketed devices B) To document identified risks and mitigation strateg...

Device RAC Exam | 94 Actual Questions and Answers 100% Correct | latest update 2024

DEVICE RAC COMPLETE ACTUAL EXAM QUESTIONS 2024. 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 woul...

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 - 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...

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 WRITTEN EXAM QUESTIONS 2024. 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 bes...

DEVICE RAC EXAM | 69 Actual Questions and Answers Verified by Expert | latest update 2024