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RAC Bundled Exams with Complete Solution | Verified | Guaranteed Success
RAC Bundled Exams with Complete Solution | Verified | Guaranteed Success
[Show more]RAC Bundled Exams with Complete Solution | Verified | Guaranteed Success
[Show more]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...
Preview 3 out of 18 pages
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 - 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...
Preview 4 out of 36 pages
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 - 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...
Facility Registration - Devices - within XX days of application or manufacturing - 30 days 
Facility Re-Registration - Devices, Drugs & Biologics - Annual 
GLP & GCP Record Retention - 5 Years - from application or 
2 Years - from approval or termination date 
IND/IDE (GCP) - Progress Report - Repor...
Preview 1 out of 4 pages
Add to cartFacility Registration - Devices - within XX days of application or manufacturing - 30 days 
Facility Re-Registration - Devices, Drugs & Biologics - Annual 
GLP & GCP Record Retention - 5 Years - from application or 
2 Years - from approval or termination date 
IND/IDE (GCP) - Progress Report - Repor...
Similar but more detailed than the Essential Requirements - General Safety and Performance 
Requirements 
This ISO standard includes the most recent update to specific medical device companies quality 
management system? - 13485:2016 
Which entity affixes it's identification number near the CE Mark...
Preview 2 out of 13 pages
Add to cartSimilar but more detailed than the Essential Requirements - General Safety and Performance 
Requirements 
This ISO standard includes the most recent update to specific medical device companies quality 
management system? - 13485:2016 
Which entity affixes it's identification number near the CE Mark...
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...
Preview 3 out of 18 pages
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 s...
A company is performing routine site monitoring of its pivotal clinical study for a blood sugar meter and 
finds one site has not consented 1/3 of its subjects properly. What is the FIRST thing the company needs 
to do? 
A. Stop the entire study 
B. Inform FDA and ask for guidance 
C. Re-train the s...
Preview 3 out of 23 pages
Add to cartA company is performing routine site monitoring of its pivotal clinical study for a blood sugar meter and 
finds one site has not consented 1/3 of its subjects properly. What is the FIRST thing the company needs 
to do? 
A. Stop the entire study 
B. Inform FDA and ask for guidance 
C. Re-train the s...
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...
Preview 4 out of 44 pages
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 - B. Labeling specifications 
Question Feedback: Labeling specifications are part of the DMR 
A company has a new oral drug, GOOD...
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...
Preview 3 out of 25 pages
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 lo...
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