Device RAC Exam With Correct Questions And Answers With complete solution

Device RAC Exam With Correct Questions And Answers With complete solution

A physician reports to a manufacturer that a patient was hospitalized with acute sepsis 
after treatment with an approved device. This side effect is not listed in the package insert. 
This event must be reported by the manufacturer to FDA no later than:
A. 5 calendar days
B. 15 calendar days
C. 30 calendar days
D. The next quarterly or annual report - C
If a device failure is occurring with greater than expected frequency and investigation of the 
problem implicates improper use by the end user, which of the following typically occurs?
A. The labeling is revised.
B. The product is recalled.
C. The product is redesigned.
D. A "Dear Doctor" letter is issued. - A
A handling and storage system for medical devices must always include:
A. Procedures for rotation of stock
B. Separate rooms or cages for release and quarantine products
C. Procedures for receipt and transfer of product
D. Environmentally controlled areas for products with shelf life - C
You have modified your 510(k) cleared device with a special 510(k). In which of the following 
cases would you need to create a new listing for the device?
A. You have added new sizes and shapes in the product portfolio.
B. You have changed the material composition of the device.
C. You have changed the package of the device.
D. None of the above. - D
According to the QSR, when an investigation of a complaint is conducted all of the following 
are requirements for inclusion in the record of the investigation EXCEPT:
A. The dates and results of the investigation
B. The nature and details of the complaint
C. Changes in procedures correcting quality problems
D. Any reply to the complainant - C
The QSR calls for the manufacturer of finished devices to carry out all of the following 
EXCEPT:
A. Conduct quality audits by individuals who do not have direct responsibility for the 
operation being audited
B. Audit operations annually
C. Document the dates and results of quality audits and re-audits
D. Have findings reviewed by management responsible for the matters audited - B
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