Cder b cber c cdrh d ocp - Study guides, Class notes & Summaries
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DEVICE RAC EXAM Questions and Answers Graded A+ 2023 update
- Exam (elaborations) • 41 pages • 2023
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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 
2 / 14 
the design input requirements, this change would be best filed as a(n): 
A. Special 510(...
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Latest Device RAC Exam Questions and Answers 2023-2024
- Exam (elaborations) • 29 pages • 2023
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Latest Device RAC Exam Questions and Answers 
2023-2024 
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 
mod- ification 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 c...
-
DEVICE RAC EXAM QUESTIONS AND ANSWERS (GRADED A)
- Exam (elaborations) • 31 pages • 2024
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DEVICE RAC EXAM QUESTIONS AND ANSWERS (GRADED A)DEVICE RAC EXAM QUESTIONS AND ANSWERS (GRADED A)DEVICE RAC EXAM QUESTIONS AND ANSWERS (GRADED A)DEVICE RAC EXAM QUESTIONS AND 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 - 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...
-
Device RAC Exam Questions with 100% Correct Answers | Latest Version 2024 | Verified
- Exam (elaborations) • 36 pages • 2024
- Available in package deal
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- $13.49
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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 Questions and Answers 100% Accurate
- Exam (elaborations) • 63 pages • 2024
- Available in package deal
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- $17.99
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Device RAC Exam Questions and Answers 100% AccurateDevice RAC Exam Questions and Answers 100% AccurateDevice RAC Exam Questions and Answers 100% AccurateDevice RAC Exam Questions and Answers 100% Accurate 
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 antibiot...
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DEVICE RAC EXAM Questions with 100% Correct Answers | Latest Version 2024 | Verified
- Exam (elaborations) • 18 pages • 2024
- Available in package deal
-
- $12.49
- + 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...
-
Device RAC Exam Study Guide | Questions with 100% Correct Answers & Explanations | Verified | Latest Update 2024
- Exam (elaborations) • 36 pages • 2024
- Available in package deal
-
- $13.49
- + 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...
-
RAC Devices Exam Prep 2024/2025 Rated A+
- Exam (elaborations) • 41 pages • 2024
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- $12.49
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1.	Which division has primary jurisdiction over a vascular graft with an antibi- otic based on primary mode of action? 
A.	CDER 
B.	CBER 
C.	CDRH 
D.	OCP 
ANS : 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. 
2.	A company wants to modify its legally marketed device such that the mod- ification does not affect the intended use or alter the fundamental scientific technology of the de...
-
DEVICE RAC EXAM 2024 with 100% correct answers
- Exam (elaborations) • 18 pages • 2024
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- $17.49
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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 - 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 with 100% Correct Answers | Verified | Latest Update 2024
- Exam (elaborations) • 18 pages • 2024
- Available in package deal
-
- $12.49
- + 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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