Cder b cber c cdrh d ocp - Study guides, Class notes & Summaries
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DEVICE RAC EXAM QUESTIONS WITH COMPLETE SOLUTIONS 2022 / 2023
- Exam (elaborations) • 13 pages • 2023
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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. Abbreviat...
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Device RAC Exam With Correct Questions And Answers With complete solution
- Exam (elaborations) • 17 pages • 2024
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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...
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RAC DEVICE EXAM QUESTIONS WITH COMPLETE SOLUTIONS
- Exam (elaborations) • 20 pages • 2023
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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 Devices Practice Exam with Complete Solutions
- Exam (elaborations) • 20 pages • 2023
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- $11.49
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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 EXAM | Questions with 100% Correct Answers | Verified | Latest Update 2024
- Exam (elaborations) • 18 pages • 2023
-
- $15.49
- + learn more
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...
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DEVICE RAC EXAM QUESTIONS WITH 100% CORRECT ANSWERS!!
- Exam (elaborations) • 18 pages • 2024
- Available in package deal
-
- $7.99
- + learn more
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 RAMP 2023 (100%CORRECT) Questions and Answers (A+).
- Exam (elaborations) • 32 pages • 2023
- Available in package deal
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- $10.99
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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 Exam Questions and Answers
- Exam (elaborations) • 27 pages • 2023
- Available in package deal
-
- $12.49
- + learn more
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...
-
DEVICE RAC 2024 Questions and Answers Graded A(Actual test)
- Exam (elaborations) • 21 pages • 2024
- Available in package deal
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- $13.49
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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...
-
DEVICE RAC EXAM Questions with 100% Correct Answers | Latest Version 2024 | Verified
- Exam (elaborations) • 18 pages • 2024
-
- $10.49
- + learn more
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...
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