Cder b cber c cdrh d ocp - Study guides, Class notes & Summaries
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DEVICE RAC EXAM QUESTIONS AND ANSWERS WITH COMPLETE SOLUTIONS ASSURED A+.
- Exam (elaborations) • 32 pages • 2023
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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...
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DEVICE RAC EXAM QUESTIONS AND ANSWERS 2024 WITH COMPLETE SOLUTION
- Exam (elaborations) • 21 pages • 2024
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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 QUESTIONS CORRECTLY ANSWERED 2024.
- Exam (elaborations) • 18 pages • 2024
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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 COMPLETE SOLUTIONS ASSURED A+.
- Exam (elaborations) • 32 pages • 2023
-
- $12.99
- + learn more
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 2024 | Questions with 100% Correct Answers | Verified | Latest Update 2024| Graded A+
- Exam (elaborations) • 75 pages • 2024
- Available in package deal
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- $9.49
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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...
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Device RAC Exam Study Guide | Questions with 100% Correct Answers & Explanations | Verified | Latest Update 2024 | 36 Pages
- Exam (elaborations) • 36 pages • 2023
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- $20.49
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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 - 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 device. If the...
-
DEVICE RAC EXAM 2024 | QUESTIONS WITH 100% CORRECT ANSWERS | 2024.
- Exam (elaborations) • 52 pages • 2024
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DEVICE RAC EXAM 2024 | QUESTIONS WITH 
100% CORRECT ANSWERS | 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 - 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 ...
-
DEVICE RAC EXAM QUESTIONS WITH CORRECT ANSWERS GRADED A+
- Exam (elaborations) • 18 pages • 2023
- Available in package deal
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- $11.49
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DEVICE RAC EXAM QUESTIONS WITH CORRECT ANSWERS 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 - 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 ch...
-
Device RAC Exam Questions with 100% Correct Answers | Latest Version 2024 | Verified
- Exam (elaborations) • 36 pages • 2024
-
- $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 - 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 device. If the...
-
DEVICE RAC EXAM QUESTIONS AND ANSWERS 2024 WITH COMPLETE SOLUTION
- Exam (elaborations) • 21 pages • 2024
- Available in package deal
-
- $12.49
- + learn more
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...
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