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DEVICE RAC Bundled Exams with Complete Solution | Verified Answers | 2024
DEVICE RAC Bundled Exams with Complete Solution | Verified Answers | 2024
[Montrer plus]DEVICE RAC Bundled Exams with Complete Solution | Verified Answers | 2024
[Montrer plus]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 fundamenta...
Aperçu 3 sur 18 pages
Ajouter au panierWhich 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 fundamenta...
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 supportiv...
Aperçu 4 sur 36 pages
Ajouter au panierWhich 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 supportiv...
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 ...
Aperçu 4 sur 36 pages
Ajouter au panier510(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 ...
A medical device manufacturer is preparing a submission that requires a Declaration of Conformity with 
design control requirements. What type of submission is the manufacturer preparing to submit to FDA? 
0 A PMA 
1 A Special 510(k), 
2 An Individual Device Exemption (IDE), 
3 An Annual Report for ...
Aperçu 2 sur 7 pages
Ajouter au panierA medical device manufacturer is preparing a submission that requires a Declaration of Conformity with 
design control requirements. What type of submission is the manufacturer preparing to submit to FDA? 
0 A PMA 
1 A Special 510(k), 
2 An Individual Device Exemption (IDE), 
3 An Annual Report for ...
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 s...
Aperçu 3 sur 18 pages
Ajouter au panierWhich 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 s...
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 lo...
Aperçu 3 sur 25 pages
Ajouter au panierIn 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 lo...
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 - B. Labeling specifications 
Question Feedback: Labeling specifications are part of the DMR 
A company has a new oral drug, GOOD...
Aperçu 4 sur 44 pages
Ajouter au panierWhich of the following is considered part of the Device Master Record? 
A. Employee training record 
B. Labeling specifications 
C. Design reviews 
D. Calibration records - B. Labeling specifications 
Question Feedback: Labeling specifications are part of the DMR 
A company has a new oral drug, GOOD...
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