Rac device Study guides, Class notes & Summaries
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![RAC DEVICE EXAM QUESTIONS WITH COMPLETE SOLUTIONS](/docpics/4028539/657c3ae0888d7_4028539_121_171.jpeg)
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RAC DEVICE EXAM QUESTIONS WITH COMPLETE SOLUTIONS
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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...
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RAC Devices Exam Prep 2024/2025 Rated A+
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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...
![RAC Device General Exam Prep Graded A+](/docpics/3195076/64ce5d33082c9_3195076_121_171.jpeg)
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RAC Device General Exam Prep Graded A+
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A 510k is Approved or Cleared? - ANSWER-Cleared 
 
A type of 510(k) submission for device modifications neither affecting the intended use nor altering its fundamental scientific technology. FDA processing time is 30 days. - ANSWER-Special 510(k) 
 
A type of 510(k) submission that is supported by conformance with guidance document(s), special controls or standards. FDA processing time is 90 days. 
 
In other words, it's a "paper comparison," showing substantial equivalence to a guidance or s...
![RAC device Quiz Questions With Complete Solutions 2023-2024](/docpics/3353595/64f23a2754041_3353595_121_171.jpeg)
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RAC device Quiz Questions With Complete Solutions 2023-2024
- Exam (elaborations) • 6 pages • 2023
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RAC device Quiz Questions With Complete Solutions 2023-2024,RAC device Quiz Questions With Complete Solutions 2023-2024,RAC device Quiz Questions With Complete Solutions 2023-2024,RAC device Quiz Questions With Complete Solutions 2023-2024
![RAC device quiz 2024 | Questions with 100% Correct Answers | Verified | Latest Update 2024| Graded A+](/docpics/4700409/65eb7862cf2b2_4700409_121_171.jpeg)
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RAC device quiz 2024 | Questions with 100% Correct Answers | Verified | Latest Update 2024| Graded A+
- Exam (elaborations) • 12 pages • 2024
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RAC device quiz 2024 | Questions with 100% 
Correct Answers | Verified | Latest Update 2024| 
Graded A+
![RAC DEVICE EXAM 2024/REAL EXAM QUESTIONS WITH CORRECT VERIFIED ANSWERS/DEVICE RAC EXAM /LATEST UPDATE 2024-2025/ALREADY GRADED A+](/docpics/5620798/666978c7725cd_5620798_121_171.jpeg)
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RAC DEVICE EXAM 2024/REAL EXAM QUESTIONS WITH CORRECT VERIFIED ANSWERS/DEVICE RAC EXAM /LATEST UPDATE 2024-2025/ALREADY GRADED A+
- Exam (elaborations) • 27 pages • 2024
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RAC DEVICE EXAM 2024/REAL EXAM QUESTIONS WITH CORRECT VERIFIED ANSWERS/DEVICE RAC EXAM /LATEST UPDATE /ALREADY GRADED A+
![RAC Device Glossary Terms – Complete Guide](/docpics/3565922/651f16bb71790_3565922_121_171.jpeg)
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RAC Device Glossary Terms – Complete Guide
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RAC Device Glossary Terms – Complete Guide
![RAC DEVICES EXAM 2024 WITH 100% CORRECT ANSWERS](/docpics/4455067/65c55368d27fc_4455067_121_171.jpeg)
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RAC DEVICES EXAM 2024 WITH 100% CORRECT ANSWERS
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What did the safe medical device act do? Answer - Extended AE reporting to user facilities, required 510ks with SE, recall authority 
 
General controls Answer - Establishment reg and device listing, GMP, labels, clearance before marketing 
 
What controls are required by the 3 US classes? Answer - Class 1 - general controls. Class 2- General and special controls (which include special labeling, PMS, and performance data) Class 3- general, special, and PMA 
 
What are special controls? Answer...
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RAC Devices/RAC Pharmaceuticals Exam Package Deal Full Solutions Pack
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RAC Devices Practice Exam 2023/2024 with Complete Solutions
RAC Devices Exam Prep Graded A+ -US High Risk
Device RAC Exam Questions and Answers
RAC devices EU Exam with Complete Solutions
RAC Exam Prep 2023/2024 Answered 100% Correct
RAC Prep Medical Devices Exam Updated 2023 Graded A+
US RAC Review Questions and Answers RAPS Modules100%

RAC device quiz Questions With Correct Answers.
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