RAC Practice Exam 1/DEVICE RAC EXAM Q&A/RAC Exam practice Q&A/DEVICE RAC EXAM QUESTIONS AND ANSWERS/RAC Sample Test/US RAC Review Questions RAPS Modules/RAC EXAM PRACTICE/US RAC Practice Exam/RAC EXAM PREP INTERNATIONAL REGULATORY
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Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic records and electronic signatures)? A Manually generated timestamped audit trails to record the date and time of operator entries and actions that create, modify or delete electronic records. B Validation of sys...
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Add to cartWhich of the following is NOT required for compliance under 21 CFR Part 11 (electronic records and electronic signatures)? A Manually generated timestamped audit trails to record the date and time of operator entries and actions that create, modify or delete electronic records. B Validation of sys...
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 fu...
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Add to cartWhich 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 fu...
Which of the following was NOT a requirement of the original Food Drug and Cosmetic Act of 1938? a) Proof of efficacy b) Proof of safety c) Authorized standards of identify d) Safe tolerances for unavoidable poisonous substances(1:1) - Answer- A: Proof of efficacy Which amendments to the FD&C Act...
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Add to cartWhich of the following was NOT a requirement of the original Food Drug and Cosmetic Act of 1938? a) Proof of efficacy b) Proof of safety c) Authorized standards of identify d) Safe tolerances for unavoidable poisonous substances(1:1) - Answer- A: Proof of efficacy Which amendments to the FD&C Act...
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 antibiotic is...
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Add to cartWhich 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 antibiotic is...
Which of the following is considered part of the Device Master Record? A. Employee training record B. Labeling specifications C. Design reviews D. Calibration records - Answer- B. Labeling specifications Question Feedback: Labeling specifications are part of the DMR A company has a new...
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Add to cartWhich of the following is considered part of the Device Master Record? A. Employee training record B. Labeling specifications C. Design reviews D. Calibration records - Answer- B. Labeling specifications Question Feedback: Labeling specifications are part of the DMR A company has a new...
In which situation is an IND not required? A) You intend to conduct a clinical trial with an investigational new drug B) You intend to conduct a clinical trial with an approved drug to support a marketing application for a new indication C) You intend to collect blood samples from subjects to l...
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Add to cartIn which situation is an IND not required? A) You intend to conduct a clinical trial with an investigational new drug B) You intend to conduct a clinical trial with an approved drug to support a marketing application for a new indication C) You intend to collect blood samples from subjects to l...
A new chemical isintroduced into a manufacturing facility. The regulatory affizirs practitioner must ensure thatwhich ofthe fOllowing documents are availablefOr the chemical? A DOT manifest B. MSDS e. Interstate Bill of Lading D. USP monograph - Answer- B. MSDS A This document is not usu...
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Add to cartA new chemical isintroduced into a manufacturing facility. The regulatory affizirs practitioner must ensure thatwhich ofthe fOllowing documents are availablefOr the chemical? A DOT manifest B. MSDS e. Interstate Bill of Lading D. USP monograph - Answer- B. MSDS A This document is not usu...
[Q]Which meeting is held with the FDA for the purpose of reaching concurrence on the key parameters of the investigational plan for a Class III device? [A] Agreement meeting [B] Determination meeting [C] Presubmission meeting [D] PMA Day-100 meeting - Answer- [A] Agreement meeting [Q]Which me...
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Add to cart[Q]Which meeting is held with the FDA for the purpose of reaching concurrence on the key parameters of the investigational plan for a Class III device? [A] Agreement meeting [B] Determination meeting [C] Presubmission meeting [D] PMA Day-100 meeting - Answer- [A] Agreement meeting [Q]Which me...
Members of IMDRF - Answer- Australia, Brazil, Canada, China, Europe, Japan, Russia, Singapore, S. Korea, US What types of evaluations are typical variable from nation to nation? - Answer- Performance and clinical evaluations What is the Helsinki Declaration? - Answer- statement of ethical prin...
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Add to cartMembers of IMDRF - Answer- Australia, Brazil, Canada, China, Europe, Japan, Russia, Singapore, S. Korea, US What types of evaluations are typical variable from nation to nation? - Answer- Performance and clinical evaluations What is the Helsinki Declaration? - Answer- statement of ethical prin...
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