Device rac Study guides, Class notes & Summaries
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![Device RAC Exam Questions with 100% Correct Answers | Latest Version 2024 | Verified](/docpics/4903359/660c7d5737201_4903359_121_171.jpeg)
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Device RAC Exam Questions with 100% Correct Answers | Latest Version 2024 | Verified
- Exam (elaborations) • 36 pages • 2024
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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 
Device RAC Exam Questions and Answers 
Device RAC Exam Questions and Answers
![DEVICE RAC EXAM 2024 | Questions with 100% Correct Answers | Verified | Latest Update 2024| Graded A+](/docpics/4700413/65eb7865cfe7d_4700413_121_171.jpeg)
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DEVICE RAC EXAM 2024 | Questions with 100% Correct Answers | Verified | Latest Update 2024| Graded A+
- Exam (elaborations) • 75 pages • 2024
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DEVICE RAC EXAM 2024 | Questions with 100% 
Correct Answers | Verified | Latest Update 2024| 
Graded A+
![DEVICE RAC EXAM – QUESTIONS & SOLUTIONS (Guaranteed Pass!)](/docpics/3566075/651f1b6edb1da_3566075_121_171.jpeg)
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DEVICE RAC EXAM – QUESTIONS & SOLUTIONS (Guaranteed Pass!)
- Exam (elaborations) • 32 pages • 2023
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DEVICE RAC EXAM – QUESTIONS & SOLUTIONS (Guaranteed Pass!)
![DEVICE RAC EXAM 2024 with 100% correct answers](/docpics/4228038/65a469d2920bd_4228038_121_171.jpeg)
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DEVICE RAC EXAM 2024 with 100% correct answers
- Exam (elaborations) • 18 pages • 2024
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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 STUDY GUIDE Questions with 100% Correct Answers | Latest Version 2024 | Verified](/docpics/4903369/660c7d5a35b35_4903369_121_171.jpeg)
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DEVICE RAC EXAM STUDY GUIDE 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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510(k) Premarket Notifications for all of the following medical devices would be reviewed by CDRH's 
Office of Device Evaluation except: 
A) High Flux Hemodialyzer 
B) Blood specimen collection device 
C) Piston syringe 
D) Cardiopulmonary bypass blood tubing - B 
A 510(k) submission for any Class III device MUST include: 
A. Clinical results summary 
B. Hazards analysis evaluation 
C. Stability evaluation 
D. Certification and summary - D 
A clinical study sponsor's representative conducts pe...
![DEVICE RAC EXAM QUESTIONS AND ANSWERS WITH COMPLETE SOLUTIONS ASSURED A+.](/docpics/3875323/655c837244aaf_3875323_121_171.jpeg)
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DEVICE RAC EXAM QUESTIONS AND ANSWERS WITH COMPLETE SOLUTIONS ASSURED A+.
- Exam (elaborations) • 32 pages • 2023
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- $12.99
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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...
2024 Device RAC Exam Questions and Answers with complete solution Graded A+
DEVICE RAC EXAM QUESTIONS AND ANSWERS 2024 WITH COMPLETE SOLUTION
![DEVICE RAC EXAM QUESTIONS AND ANSWERS WITH COMPLETE SOLUTIONS ASSURED A+.](/docpics/3874810/655c73fb06078_3874810_121_171.jpeg)
-
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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