Rac questions and answers - Study guides, Class notes & Summaries
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RAC Questions And Answers 2023
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When is an NDA annual report due? - ANS-60 days after the anniversary date of U.S. approval of the 
application. NDA 
Reporting Period ? All Blood and HCT/P Problems - ANS-45 calendar days of Fatal/Life 
threateneing/Disabling/Surgical Intervention and hospitalization 
Reporting Period? Postmarket Device Death, Serious Injury, Malfunction - ANS-Within 30 calendar days 
of awareness 
Reporting Period? Device Special FDA, or Remedial Action to Prevent Death/Harm - ANS-Within 5 work 
days of aw...
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RAC DRUGS Questions and answers latest update
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RAC DRUGS Questions and answers latest update
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TECHNICIAN URAC QUESTIONS AND ANSWERS
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TECHNICIAN URAC QUESTIONS AND ANSWERS
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RAC Questions and Answers
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RAC Questions and Answers 
 
Administrative Procedure Act ANSWER federal law enacted in 1946, "notice and comment rulemaking" 
 
1906: The Pure Food and Drug Act (PFDA) ANSWER interstate commerce 
labeling 
 
1912 Pure Food and Drug Act ANSWER revised in 1912, stated that a drug was misbranded if its label contained a "false and fraudulent" statement regarding "curative or therapeutic 
effect." 
 
1938 FD&C Act ANSWER • extended control to cosmetics and therapeutic 
devices 
• required...
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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...
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US RAC Exam Prep Questions and Answers 100% Correct
- Exam (elaborations) • 37 pages • 2024
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US RAC Exam Prep Questions and Answers 100% CorrectUS RAC Exam Prep Questions and Answers 100% CorrectUS RAC Exam Prep Questions and Answers 100% CorrectUS RAC Exam Prep Questions and Answers 100% CorrectAnswers 100% Correct 
 
30-day hold - ANSWER-(aka 30-day safety review) Time frame between filing a protocol under an IND and the FDA approval to proceed with enrollment. Also, the time period between when a company submits an IND and when it can initiate a protocol. This timeline may be extende...
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Device RAC Exam Questions and Answers 100% Accurate
- Exam (elaborations) • 63 pages • 2024
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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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EU RAC Exam 2024 | Questions with 100% Correct Answers | Verified | Latest Update | Graded A+
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EU RAC Exam 2024 | Questions with 100% Correct Answers | Verified | Latest Update | Graded A+ 
protocol is approved to ensure what? - That it meets applicable quality and study design requirements. 
First course of action to market a new class III medical device technology in the shortest time is... - to collect required clinical data 
Instructions for Use language is defined by the Member State. Having a local distributor is not a mandatory requirement. - Transposed Meidcal Devices Directive. 
...
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RAC Exam Questions and Answers (Graded A)
- Exam (elaborations) • 17 pages • 2024
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RAC Exam Questions and Answers (Graded A)RAC Exam Questions and Answers (Graded A)RAC Exam Questions and Answers (Graded A)RAC Exam Questions and Answers (Graded A)RAC Exam Questions and Answers (Graded A) 
What source should the regulatory professional consult to determine when a product's patent and exclusivity will expire? 
 
A. Federal Register 
B. The Orange Book 
C. Patent and Trademark Office 
D. Copyright Office - ANSWER-B. The Orange Book 
 
An IVD submission could be submitted as a(n)...
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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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