Cder b cber c cdrh d ocp - Study guides, Class notes & Summaries
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DEVICE RAC UPDATED Exam Questions and CORRECT Answers
- Exam (elaborations) • 18 pages • 2024
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DEVICE RAC UPDATED Exam Questions 
and CORRECT Answers 
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, thi...
-
Device RAC Exam Questions | Questions with 100% Correct Answers | Verified | Latest Update 2024
- Exam (elaborations) • 18 pages • 2024
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- $12.49
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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 - 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...
-
RAC Exam 2023/2024 with 100% correct answers
- Exam (elaborations) • 36 pages • 2023
- Available in package deal
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- $16.49
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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 - correct 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 o...
-
DEVICE RAC EXAM QUESTIONS with Verified Answers
- Exam (elaborations) • 18 pages • 2024
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- $10.49
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DEVICE RAC EXAM QUESTIONS with Verified Answers 
1. C 
2. A 
3. C 
4. A 
Which division would have primary jurisdiction over a vas- 
cular graft with an antibiotic based on primary mode of 
action? 
A. CDER 
B. CBER 
C. CDRH 
D. OCP 
A company wants to modify its legally marketed device 
such that the modification does not affect the intended 
use or alter the funda
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DEVICE RAC 2024 Questions and Answers Graded A(Actual test)
- Exam (elaborations) • 21 pages • 2024
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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...
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Device RAC Exam Questions with Complete Solutions 100% Verified
- Exam (elaborations) • 36 pages • 2023
- Available in package deal
-
- $11.49
- + learn more
Device RAC Exam Questions with Complete Solutions 100% Verified 
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 - Correct 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 th...
-
Device RAC Exam Questions | Questions with 100% Correct Answers | Verified | Latest Update 2024
- Exam (elaborations) • 18 pages • 2023
- Available in package deal
-
- $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...
-
RAC DEVICE EXAM 2023/2024 WITH 100% CORRECT ANSWERS
- Exam (elaborations) • 18 pages • 2023
- Available in package deal
-
- $17.49
- + 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 - 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 AND ANSWERS WITH COMPLETE SOLUTIONS ASSURED A+.
- Exam (elaborations) • 32 pages • 2023
-
- $11.99
- + 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 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...
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