Misbranded device - Study guides, Class notes & Summaries

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 - 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 requireme...

DEVICE RAC EXAM 2024 | Questions with 100% Correct Answers | Verified | Latest Update 2024| Graded 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 - 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...

DEVICE RAMP 2023 (100%CORRECT) Questions and Answers (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: correct 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 requirements,...

DEVICE RAC 2024 Questions and Answers Graded A(Actual test) 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, th...

RAC DEVICE EXAM QUESTIONS WITH COMPLETE SOLUTIONS 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 - ANSC 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 be...

RAC Practice Exam Questions and Answers Rated A+ 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. 30 calendar days. Serious injury must be reported within 30 days. 21 CFR 803.50(a). Und...

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 - 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 requireme...

RAC Devices Practice Exam with Complete Solutions 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 - ANSC 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 be...

DEVICE RAC 2024 Questions and Answers Graded A(Actual test) 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, th...

Which division has 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. CDRH In this combination of a device and a drug, the primary mode of action is that of the vascular graft (device). The antibiotic is supportive in this case. 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 devi...